This Professional Resource gives subscribers

additional insight related to the Recommendations published in

PHARMACISTS LETTER / PRESCRIBERS LETTER

September 2016 ~ Resource #320947

Anticipated Availability of First-Time Generics

To help explain the benefits of generic drugs to your patients, the FDA has patient education materials available at
[Link]

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Ammonul
(Medicis)
Asacol HD
(Warner Chilcott)
Cordran SP
(Aqua)
Crestor
(AstraZeneca)
Delalutin
(Bristol-Myers Squibb)
Diabeta
(Sanofi Aventis)
Doryx
(Mayne)
Enablex
(Novartis)
Exelon
(Novartis)
Fenoglide
(Santarus)
Frova
(Endo)
Fusilev
(Spectrum)

Sodium benzoate/Sodium
phenylacetate
Mesalamine delayed-release tablet

Trigen (Ailex)

Generic now available

Zydus

Flurandrenolide 0.05% cream

Cintex (Teligent)

Generic now available (authorized

generic)
Generic now available

Rosuvastatin calcium

Apotex, Avkare (Par), Citron (Aurobindo),

Glenmark, Mylan, Par, Sandoz, Sun, Teva
ANI Pharmaceuticals (McGuff/Aspen)

Generic now available

Impax (CorePharma)

Generic now available

Doxycycline hyclate delayedrelease tablet 50 mg, 200 mg

Darifenacin

Mylan

Generic now available

Par (Anchen), Teva

Generic now available

Rivastigmine transdermal patch

Alvogen

Generic now available

Fenofibrate tablet 40 mg, 120 mg

Mylan

Generic now available

Frovatriptan

Glenmark, Mylan, Par

Generic now available

Levoleucovorin 50 mg/vial

West-Ward (Eurohealth)

Generic now available

Hydroxyprogesterone caproate
injection (brand discontinued)
Glyburide

Generic now available

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 2 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Gleevec
(Novartis)
Glumetza
(Santarus)
Glyset
(Pharmacia & Upjohn)
Imitrex
(GlaxoSmithKline)
Integrilin
(Schering)
Intermezzo
(Purdue)
Lodosyn
(Aton)
Naftin
(Merz)
Nasonex
(Merck)
Neoprofen
(Recordati Rare)
Nilandron
(Concordia)
Nuvigil
(Teva)
Oxistat
(Fougera)
Tikosyn
(Pfizer)
Trizivir
(GlaxoSmithKline)
Voltaren
(GlaxoSmithKline)

Imatinib

Apotex, Sun, Teva

Generic now available

Metformin extended-release tablet

Lupin

Generic now available

Miglitol tablets

Sun (Orient)

Generic now available

Sumatriptan nasal spray

Lannett

Generic now available

Eptifibatide

AuroMedics (Aurobindo), Teva

Generic now available

Zolpidem sublingual tablet

Gavis (Novel)

Generic now available

Carbidopa

Generic now available

Naftifine 2% cream

Alvogen, Avkare (Alvogen), Amerigen,

Edenbridge
Taro

Mometasone nasal spray

Apotex

Generic now available

Ibuprofen lysine

X-Gen (Exela)

Generic now available

Nilutamide

ANI Pharmaceuticals

Generic now available

Armodafinil

Mylan

Generic now available

Oxiconazole 1% cream

Taro

Generic now available

Dofetilide

Mayne (Tiger)

Generic now available

Abacavir, lamivudine, zidovudine

Lupin

Generic now available

Diclofenac 1% gel

Amneal

Generic now available

Generic now available

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 3 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Zegerid
(Santarus)
Zegerid OTC
(Bayer)
Ziana
(Medicis)
Cubicin
(Cubist)
Edecrin
(Aton)
Epzicom
(GlaxoSmithKline)
Zegerid
(Santarus)
Remicade
(Janssen)
Azor
(Daiichi Sankyo)
Benicar/Benicar HCT
(Daiichi Sankyo)

Omeprazole/Sodium bicarbonate
capsule
Omeprazole/Sodium bicarbonate
capsule
Clindamycin phosphate 1.2%/
Tretinoin 0.025%
Daptomycin

Ajanta, Dr. Reddys, Northstar Rx (Ajanta),

Par
Perrigo (CVS, Walgreens)

Generic now available

Teva (Actavis)

Generic now available

Crane, Hospira, Teva

2nd half of 201619

Ethacrynic acid 25 mg tablet

Edenbridge

2nd half of 2016153

Abacavir sulfate/Lamivudine
600 mg/300 mg tablet
Omeprazole/Sodium bicarbonate
suspension
Infliximab

Aurobindo, Cipla, Hetero, Matrix, Mylan,

Teva
Ajanta

September 201690

Hospira (biosimilari)

4th quarter 2016143

Olmesartan/Amlodipine

Macleods, Matrix, Teva, Torrent

October 2016

Olmesartan/Olmesartan HCTZ

Olmesartan: Alembic, Alkem, Amneal,

Aurobindo, Glenmark, Jubilant, Macleods,
Mylan, Sandoz, Sciegen, Teva, Torrent
Olmesartan HCTZ: Aurobindo, Macleods,
Mylan, Prinston, Teva
Accord, Handa, Mylan

October 201624

Seroquel XR
(AstraZeneca)
Kaletra
(Abbott)
Lantus
(Sanofi-Aventis)

Quetiapine extended-release tablet

Lopinavir/Ritonavir

Insulin glargine

Tablet: Aurobindo, Cipla, Hetero, Matrix,

Macleods, Mylan
Oral solution: Cipla
Eli Lilly/Boehringer Ingelheim

Generic now available

2nd half of 201647

November 20162
December 20169,36,137
December 2016109 (This product
will be a new brand of insulin
glargine [Basaglar], not a generic.)
More. . .

Copyright 2016 by Therapeutic Research Center

3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 4 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Norvir
(Abbvie)
ProAir HFA
(Teva)
Relpax
(Pfizer)
Aggrenox
(Boehringer Ingelheim)
Azilect
(Teva)
Tamiflu
(Genentech)
Minastrin 24 Fe
(Warner Chilcott)
Pristiq
(Wyeth)
Vytorin
(Merck)
Zetia
(Merck)
Strattera
(Lilly)
Adcirca
(Lilly)
Prezista
(Janssen)
Reyataz
(Bristol-Myers Squibb)
Sustiva
(Bristol-Myers Squibb)

Ritonavir 100 mg tablet

Aurobindo, Cipla, Mylan, Hetero,h,73 Roxane

December 20169,137

Albuterol

Perrigof,34

December 201634

Eletriptan

Ajanta, Apotex, Mylan, Teva

December 201624

Aspirin/Dipyridamole

Teva

Rasagiline mesylate tablet

Alkem, Apotex, Mylan, Orchid, Sandoz,f,30

January 2017 (note: authorized

generics now available)
February 201730

Oseltamivir capsules

Natco

Before February 2017139

Ethinyl estradiol/Norethindrone
acetate/Ferrous fumarate
Desvenlafaxine succinate
extended-release tablet
Ezetimibe/Simvastatin

Lupin

March 2017151

Actavis, Alembic, Mylan, Lupin, Roxane,

Sandoz
Impax, Mylan, Tevaf,134

March 201733

Ezetimibe

Actavis, Mylan, Sandoz, Teva

April 201712,140

Atomoxetine

May 2017

Tadalafil

Apotex, Aurobindo, Dr. Reddys, Glenmark,

Hetero, Mylan, Sandoz, Sun, Zydus
Aurobindo, Synthon

November 201718

Darunavir tablet

Hetero, Lupin, Mylan, Teva

November 201779

Atazanavir

Aurobindo, Emcure, Matrix, Teva

December 201752

Efavirenz

Tablet: Aurobindo, Cipla, Emcure, Hetero,

Macleods, Matrix, Micro Labs, Mylan, Par,
Strides
Capsule: Aurobindo, Cipla, Micro Labs

December 201724

April 201728,134

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 5 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Truvada
(Gilead)
Viagra
(Pfizer)

Emtricitabine/Tenofovir
disoproxil fumarate tablet
Sildenafil

December 201725

Viread
(Gilead)
Copaxone
(Teva)
Solodyn
(Medicis)

Tenofovir disoproxil fumarate

tablet
Glatiramer 40 mg/mL

Aurobindo, Cipla, Hetero, Lupin,f,25 Matrix,

Mylan,f,25 Strides Arcolab, Teva
Actavis, Ajanta, Amneal, Apotex, Aurobindo,
Dr. Reddys, Hetero, Macleods, Mylan,
Rubicon
Aurobindo, Cipla, InvaGen, Lupin, Macleods,
Matrix, Mylan, Strides Arcolab, Teva
Dr. Reddys,h,94 Mylan,h,146
Momenta/Novartis,h,146 Sandozh,70
Apotex,h,117 Aurobindo, Mylan, Sandoz,
Sidmak, Sun, Teva

Treximet
(Pozen)
Factive
(Cornerstone)
Sensipar
(Amgen)
Enbrel
(Amgen)
Lexiva
(Vertex)
Remodulin
(United Therapeutics)
Acanya
(Valeant)
Clolar
(Genzyme)
Emend
(Merck)
Latuda
(Sunovion)

Minocycline extended-release
tablet 55 mg, 65 mg, 80 mg,
105 mg, 115 mg
Sumatriptan/Naproxen

December 2017 (or earlier)91,92

December 20178
First half 2018146
February 201824

Gemifloxacin tablet

Alphapharm,f,102 Dr. Reddys, Mylan, Par,

Tevaf,102
Orchid

February 2018102
March 201829

Cinacalcet tablet

Actavis, Mylan, Teva

March 201851

Etanercept

Sandoz (biosimilar1)

April 2018 or later159

Fosamprenavir

Lupin, Mylan

June 2018d,130

Treprostinil injection

Sandoz

June 2018 (or earlier)126

Benzoyl peroxide 2.5%/

Clindamycin phosphate 1.2%
Clofarabine

Actavis

July 2018 (or earlier)87

Abon,h,142 Sun,h,101 Zydus

July 2018d

Aprepitant capsule

Sandoz

July 2018e,113

Lurasidone

Amneal, Emcure, InvaGen,h,135 Lupin, MSN,

Sun

July 2018d
More. . .

Copyright 2016 by Therapeutic Research Center

3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 6 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Atripla
(Gilead)
Aloxi
(Eisai)
Levitra
(GlaxoSmithKline)
Vesicare
(Astellas)
Finacea
(Bayer)
Fortesta
(Endo)
Lyrica
(Pfizer)

Efavirenz/Emtricitabine/Tenofovir
disoproxil fumarate
Palonosetron injection

August 2018e,68

Vardenafil tablet

Aurobindo, Cipla, Hetero, Macleods, Matrix,

Teva
Akorn, Aurobindo, Dr. Reddys, Exela,
Fresenius Kabi, Sandoz, Teva
Macleods, Teva

Solifenacin succinate

Actavis, Teva

October 201820

Azelaic acid

Glenmark

November 2018

Testosterone gel

Actavis

November 2018d,65

Pregabalin

December 201850

Zyclara
(Medicis)
Ranexa
(Gilead)
AzaSite
(InSite Vision)
Emend
(Merck)
Faslodex
(AstraZeneca)
Exjade
(Novartis)
Sporanox
(Janssen)

Imiquimod cream

Capsule: Actavis, Alembic, Apotex,

Aurobindo, Lupin, Macleods, Mylan, Sandoz,
Teva, Wockhardt
Oral solution: Apotex, Lupin, Novel
Actavisf,17

Ranolazine

Lupin, Teva

February 201981

Azithromycin 1% ophthalmic
solution
Fosaprepitant injection

Mylan,f,13 Sandoz

March 2019e,13,43

Accord,h,53 Fresenius Kabi, Sandoz

March 201935

Fulvestrant

Sandozf,144

March 2019144

Deferasirox tablets for oral

suspension
Itraconazole solution

Actavis, Mylanh,11

April 2019d

Ferah,132

June 2019d

September 2018 (or earlier)78

October 2018e,10

January 2019 (or earlier)17

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 7 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Uloric
(Takeda)
Edluar
(Orexo)
Fentora
(Cephalon)
Treanda
(Teva)
Daliresp
(AstraZeneca)
Namenda XR
(Forest)
Silenor
(Somaxon)
Vigamox
(Alcon)
Delzicol
(Warner Chilcott)
Safyral
(Bayer)
Chantix
(Pfizer)
Dexilant
(Takeda)
Lialda
(Shire)
Absorica
(Ranbaxy)
Ofirmev
(Mallinckrodt)

Febuxostat

Alembic, Dr. Reddys,h,97 Hetero,h,97 Lupin,h,97

Mylan, Ranbaxy,h,97 Roxane,h,106 Sunh,97
Mylan, Par

June 2019d,16

Zolpidem sublingual tablet

September 2019e,154.155

Fentanyl citrate buccal/sublingual

tablet
Bendamustine 25 mg/vial and
100 mg/vial
Roflumilast

Actavis,f,72 Impax,f,57 Mylanf,89

October 201972

Accord, Glenmark, Hospira, InnoPharma,

Sagentf,107
Strides

November 2019111

Memantine extended-release
capsule
Doxepin

Amneal,f,3 Mylan, Sun,h,118 Teva,f,58

Wockhardth,118
Actavis, Mylan, Par, Zydus

January 2020 (or earlier)39

Moxifloxacin ophthalmic

Actavis, Akorn, Apotex, Lupin, Teva

March 2020e,6

Mesalamine delayed-release
capsule
Drospirenone/Ethinyl
estradiol/Levomefolate calcium
Varenicline

Mylanh,115

April 2020d

Actavis

April 2020d,46

Apotex, Mylan, Teva

May 2020d,49

Dexlansoprazole

June 2020104

Mesalamine delayed-release tablet

Impax,f,104 Par (acquired Handas ANDA),132

TWif,93
Allergan,f,42,145 Mylan,h,38 Zydus,h,76

Isotretinoin

Actavisf,88

December 2020 (or earlier)88

Acetaminophen injection

Paddock, Perrigo,31 Sandoz

December 2020 (or earlier)31

January 2020156
January 20203

June 202042,145

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 8 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Latisse
(Allergan)
Sutent
(Pfizer)
Tarceva
(OSI)
Diclegis
(Duchesnay)
Perforomist
(Mylan)
Bystolic
(Forest)

Bimatoprost 0.03%

Apotex, Sandoz

January 202145

Sunitinib

Mylan

February 2021

Erlotinib tablet

Mylan

May 2021e,141

Doxylamine/Pyridoxine

Actavis

June 2021e,158

Formoterol inhalation solution

Teva

June 2021

Nebivolol

September 2021 (or earlier)67

Emtriva
(Gilead)
Brovana
(Sunovion)
Revlimid
(Celgene)
Vimpat
(UCB)

Emtricitabine capsule

Actavis,f,67 Alkem,f,67 Amerigen,f,67

Glenmark,f,63,67 Hetero,f,67 Indchemie,f,67
Torrentf,67
Aurobindo, Cipla, Matrix

September 2021d,4

Arformoterol

Teva

November 2021

Lenalidomide

Allerganf,23

March 202223

Lacosamide

Tablet: Accord, Actavis, Alembic, Amneal,

Aurobindo, Glenmark, MSN, Mylan, Sun
Oral solution: Amneal, Apotex, Glenmark

March 20225

Zipsor
(Depomed)
Alimta
(Lilly)
Banzel
(Eisai)

Diclofenac potassium liquid-filled

capsule
Pemetrexed

Actavis,f,95 Biopharma

March 2022 (or earlier)95

Accord, APP, Emcure,h,69 Heritage,h,69

Hospira, Sandoz,h,56 Teva
Glenmark, Hetero,h,80 Lupin,h,80 Mylan,
Roxane

May 2022d

Viibryd
(Forest)

Vilazodone

Teva

June 2022d,21

Rufinamide

May 2022 (or earlier)48

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 9 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Januvia
(Merck)
Toviaz
(Pfizer)

Sitagliptin

Actavis, Apotex, Mylan, Sandoz, Sun, Teva

July 2022d,21,124

Fesoterodine extended-release
tablet

July 2022d,82,147

Pralatrexate

Actavis, Accord,h,108 Alembic, Amerigen,

Amneal, Aurobindo, Cadila,h,108 Dr. Reddys,
Impax,h,108 Mylan,h,147 Lupin, Sandoz, Sun,
Wockhardt,h,82 Zydush,108
Teva

November 2022149

Maraviroc

Hetero

November 2022d,21

Sodium oxybate

Amneal,h,7 Par,h,7 Roxaneh,7

December 2022d,7

Prasugrel

Aurobindo, Hec Pharm,h,26 Mylan, Parh,148

January 2023d

Naproxen/Esomeprazole
magnesium delayed-release tablet
Lisdexamfetamine

Actavis,h,77 Anchen,h,77 Dr. Reddys, Lupin,h,77

Mylanh,77
Actavis, Amneal, Mylan, Roxane, Sandoz

February 2023d,77

Magnesium sulfate anhydrous,

potassium sulfate, sodium sulfate
Rilpivirine

Paddock

March 2023

Strides Arcolab

April 2023

Gabapentin

Actavis, Incepta,f,98 Zydusf,98

January 2024 (or earlier)62,98

Pitavastatin

Aurobindo, Mylan,h,138 Zydush,136

February 2024d

Olopatadine 0.2% ophthalmic

solution
Tapentadol tablet

Actavis, Apotex, Teva, Wockhardth,100

May 2024d

Actavis, Alkem, Roxane

June 2025d,125

Dasatinib

Apotex

March 2026e,152

Folotyn
(Spectrum)
Selzentry
(Pfizer)
Xyrem
(Jazz)
Effient
(Eli Lilly)
Vimovo
(Horizon)
Vyvanse
(Shire)
Suprep
(Braintree)
Edurant
(Janssen)
Gralise
(Depomed)
Livalo
(Kowa)
Pataday
(Alcon)
Nucynta
(Depomed)
Sprycel
(Bristol-Myers Squibb)

February 202355

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 10 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Janumet
(Merck)
Janumet XR
(Merck)
Natazia
(Bayer)
Aplenzin
(Valeant)
Cambia
(Depomed)
Nuedexta
(Avanir)
AndroGel 1.62%
(AbbVie)
Ampyra
(Acorda)
Lumigan
(Allergan)
Epiduo
(Galderma)
Fanapt
(Vanda)
Nexavar
(Bayer)
Oracea
(Galderma)
Promacta
(Novartis)

Sitagliptin/Metformin

Actavis, Apotex, Sandoz

April 2026d,21

Sitagliptin/Metformin extendedrelease tablet

Dienogest/estradiol valerate

Anchen, Teva

April 2026d,21

Actavis, Lupin,h,61 Teva

May 2026d,61

Bupropion hydrobromide
extended-release tablet
Diclofenac potassium oral
solution 50 mg
Dextromethorphan/Quinidine

Actavis, Paddock,h,105 Parf,83

June 2026e,83

Par

June 2026e,150

Impax,f,116 Par, Sandoz,f,103 Wockhardtf,85

July 2026 (or earlier)85,103

Testosterone

Actavis,h,44 Perrigo

October 2026d

Dalfampridine extended-release
tablet
Bimatoprost ophthalmic solution
0.01%
Adapalene 0.1%/Benzoyl
peroxide 2.5%
Iloperidone

Accord, Actavis, Allergan,f,96,119 Aurobindo,

Roxane, Alkem, Mylan,h,96 Sun, Teva
Actavis,f,123 Apotex, Hi-Tech,f,123 Lupin,f,123
Sandoz
Actavis, Glenmark, Parf,131

2027 (or earlier)e,96,119-122

July 2027e,131

Inventia, Roxanef,157

November 2027157

Sorafenib

Mylan

December 2027d,21

Doxycycline 40 mg capsule

Amneal, Lupin, Mylan

December 2027110

Eltrombopag

Hetero

February 2028d,21

Differin
(Galderma)

Adapalene topical solution 0.1%

Call (Rochester)

May 2028

June 2027123

More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 11 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Canasa
(Aptali)
Nucynta ER
(Depomed)
Onglyza
(Bristol-Myers Squibb)
Staxyn
(Bayer)
Pennsaid
(Horizon)
Colcrys
(Takeda)
Lo Loestrin Fe
(Actavis)
Tygacil
(Wyeth)
Isentress
(Merck)
Quartette
(Teva)
Moxeza
(Alcon)
Qsymia
(Vivus)
Savella
(Forest)
Tykerb
(Novartis)
Travatan Z
(Alcon)
Suboxone
(Reckitt Benckiser)

Mesalamine rectal suppository 1 g

Mylan, Sandoz

June 2028d,133

Tapentadol extended-release
tablet
Saxagliptin

Actavis

September 2028d,125

Actavis,h,99 Amneal, Aurobindo, Par

November 2028d

Vardenafil orally disintegrating

tablet
Diclofenac sodium 2% solution

Actavis, Macleods, Par

December 202840

Amneal, Lupin, Paddock, Perrigo,f,66 Taro

January 2029 (or earlier)66

Colchicine

Actavis, Hikma,h,64 Par

February 2029d

Ethinyl estradiol/Norethindrone
acetate/Ferrous fumarate
Tigecycline injection

Glenmark, Jai (Mylan)

February 2029e,32

Fresenius Kabi, Sandoz

February 202974

Raltegravir tablet

Hetero

March 2029d,21

Levonorgestrel/Ethinyl estradiol

Lupin

March 2029d,21

Moxifloxacin ophthalmic solution

Lupin

May 2029d,6

Phentermine/Topiramate
extended-release capsule
Milnacipran

Actavish,41

June 2029d

Amneal, Apotex,h,14 Glenmark,f,127 Hetero,h,14

Lupin, Mylan, Par,h,14 Ranbaxyh,14
Natco

September 2029e,127 (may be

authorized generic)
September 2029d,21

Apotex, Mylan, Par

October 2029d,128

Actavish,86

March 2030d

Lapatinib
Travoprost 0.004% ophthalmic
solution
Buprenorphine/Naloxone
sublingual film

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(Professional Resource #320947: Page 12 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Jevtana
(Sanofi Aventis)
Giazo
(Valeant)
Multaq
(Sanofi-Aventis)
Contrave
(Orexigen)
Zubsolv
(Orexo)
Alocril
(Allergan)
Avandamet
(SB Pharmco)
Avandaryl
(SB Pharmco)
Avandia
(SB Pharmco)
Axiron
(Eli Lilly)

Cabazitaxel

Breckenridgeh,54

October 2030d

Balsalazide 1.1 g tablet

Apotex,h,129 Par, Mylan

June 2031e,75

Dronedarone

Actavis, Alkem, Glenmark

June 2031

Bupropion/Naltrexone sustained
release tablet
Buprenorphine/Naloxone
sublingual tablet
Nedocromil ophthalmic

Actavish,114

January 2032d

Actavish,84

September 2032d

Akorn

Uncertaing

Rosiglitazone/Metformin

Teva

Uncertain27 (brand discontinued)

Rosiglitazone/Glimepiride

Teva

Uncertain27 (brand discontinued)

Rosiglitazone

Uncertain27

Testosterone transdermal solution

Actavis, Dr. Reddys, Mylan, Roxane,

Sandoz, Teva, Hikma
Actavis, Amneal,h, 112 Lupin,h,112 Perrigo

Bloxiverz
(Eclat)
CellCept
(Roche Palo)
Exalgo
(Mallinckrodt)
Exelon
(Novartis)

Neostigmine

Eurohealth

Uncertain (patents invalidated;

generic could launch during appeal
process)112
Uncertaing

Mycophenolate mofetil
hydrochloride injection
Hydromorphone extended-release
tablet 32 mg
Rivastigmine oral solution (brand
discontinued)

Bedford Labs

Uncertaing

Actavis, Osmotica

Uncertaing

Ranbaxy

Uncertaing (brand discontinued)

Oxytrol
(Actavis)

Oxybutynin transdermal patch

Teva

Uncertain37
More. . .

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(Professional Resource #320947: Page 13 of 21)

Branda
(Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Prandimet
(Novo Nordisk)
Renagel
(Genzyme)
Renvela
(Genzyme)
Rezira
(Hawthorn)

Repaglinide/metformin tablet

Lupin

Uncertaing

Sevelamer hydrochloride (oral

suspension)(brand not available)
Sevelamer carbonate (oral
suspension)
Hydrocodone/pseudoephedrine
oral solution

Impaxf,15

Uncertain (brand discontinued)

Impaxf,15

Uncertaing

Coastal, Tris Pharma, Paddock (Perrigo)

Uncertaing

Sarafem
(Apil)
Welchol
(Daiichi Sankyo)

Fluoxetine tablet

Teva

Uncertaing

Colesevelam tablet and oral

suspension

Impax,f,22 Actavis,h,71 Glenmarkf,59

Uncertain22,59

a.
b.
c.
d.
e.
f.
g.
h.
i.

This list is not all-inclusive.

Current through August 2016. These are manufacturers with either approval or tentative approval to market the generic version of the drug unless
otherwise noted. For drugs already available, manufacturers with tentative approval are not listed.
Generic availability is subject to change as a result of litigations and patent exclusivities.
Patent challenged; availability may be sooner than patent expiration date.
Generic manufacturer has settled patent litigation with the brand manufacturer. Generic availability may be sooner than patent expiration date.
Generic manufacturer has not received approval or tentative approval from the FDA, but has settled patent litigation with the brand manufacturer.
Patents have expired; however, generics are not yet available.
Generic manufacturer has not received approval or tentative approval from the FDA, but has filed patent challenge.
A biosimilar is not a generic. Biosimilars and their reference product are complex biologic medicines that originate in living organisms. A biosimilar is not
the exact duplicate of the reference biologic, but is very similar and is expected to have the same efficacy and safety for its approved indications.60

Users of this resource are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and internet links in this article were current as of the date of publication.

More. . .
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[Link] ~ [Link] ~ [Link] ~ [Link]

(Professional Resource #320947: Page 14 of 21)

Project Leader in preparation of this professional

resource: Melanie Cupp, Pharm.D., BCPS

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(Accessed
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2013.
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(Accessed
August 27, 2016).
111. Anon. Glenmark Pharma gets US FDA approval for
bendamustine HCl and two oral contraceptives.
March
28,
2016.
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112. Anon. Acrux and Eli Lilly to appeal patent ruling on
Axiron.
August
24,
2016.
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8052BA82CDD4823A4D4C0625. (Accessed August
27, 2016).
113. Food and Drug Administration. ANDA approval
letter. Sandoz generic Emend. May 13, 2016.
[Link]
a/2012/[Link].
(Accessed
August 29, 2016).
114. Anon. Orexigen announces receipt of paragraph IV
certification
notice.
April
22,
2015.
[Link]
(Accessed August 29,
2016).

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(Professional Resource #320947: Page 19 of 21)

115. Anon. Mylan in patent lawsuit. November 20, 2015.

[Link] (Accessed August 24, 2016).
116. Lawson A. Avanir prevails over Par, Impax in
Nuedexta
patent
row.
May
1,
2014.
[Link]
(Accessed August 27, 2016).
117. United States District Court for the District of New
Jersey. Medicis Pharmaceuticals Corporation vs
Apotex Inc. and Apotex Corp. Complaint for patent
infringement.
April
15,
2015.
[Link] (Accessed August 27, 2016).
118. Anon. Forest Laboratories, Inc. (FRX) files lawsuit
against several companies for infringement of
Namenda XR patents.
February 3, 2014.
[Link] (Accessed August
29, 2016).
119. Anon. Acorda soars, settles patent dispute with
Allergan.
October
6,
2015.
[Link]
(Accessed August 27, 2016).
120. Anon.
Acorda Therapeutics (ACOR) discloses
settlement agreement with Actavis regarding
Ampyra.
October
5,
2015.
[Link] (Accessed August 27, 2016).
121. Anon.
Acorda Therapeutics (ACOR) enters
settlement with Aurobindo Pharma. December 10,
2015.
[Link]
a+Therapeutics+(ACOR)+Enters+Settlement+with+A
urobindo+Pharma/[Link].
(Accessed
August 27, 2016).
122. Anon. Sun Pharma settles patent litigation with
Acorda Therapeutics.
October 21, 2015.
[Link]
are/biotech/pharmaceuticals/sun-pharma-settlespatent-litigation-with-acordatherapeutics/articleshow/[Link]. (Accessed
August 27, 2016).
123. Decker S. Allergan wins lawsuit against Lupin, two
others over Lumigan.
January 15, 2014.
[Link]
kbyC4in7J/[Link]. (Accessed August 27,
2016).
124. Anon. Sun Pharma gets FDA nod for generic
version
of
Januvia.
April
16,
2013.
[Link] (Accessed August 26, 2016).
125. Anon. Depomed announces favorable Markman
ruling in Nucynta and Nucynta ER patent litigation.
February
8,
2016.
[Link]
d-announces-favorable-markman-ruling-in-nucynta-

[Link].
(Accessed
August 27, 2016).
126. Kass D. Sandoz, UTC settle generic Remodulin
patent
suit.
September
30,
2015.
[Link]
(Accessed
August 31, 2016).
127. Shine J. Glenmark settles patent war over Savella.
December 21, 2015.
[Link]
Companies/OYBtDHxTAbNVlp3RYOkCCI/[Link].
(Accessed
August 27, 2016).
128. Food and Drug Administration. ANDA approval
letter. Apotex generic Travatan Z. July 10, 2016.
[Link]
etter/2015/[Link].
(Accessed
August 29, 2016).
129. Kass D. Valeant hits Apotex with patent suit over
colitis drug.
October 1, 2015.
[Link]
[Link]/articles/709788/valeant-hits-apotex-withpatent-suit-over-colitis-drug. (Accessed August 29,
2016).
130. James B. ViiV, Vertex sue over Mylans bid to
market generic Lexiva.
August 24, 2012.
[Link]
(Accessed August 22, 2016).
131. Davis R. Galderma, Actavis settle generic Epiduo
suit ahead of trial. April 13, 2015. [Link]
[Link]/articles/642310/galderma-actavis-settlegeneric-epiduo-suit-ahead-of-trial.
(Accessed
August 27, 2016).
132. Anon. Par Pharmaceutical acquires rights to market
and distribute generic Dexilant in the U.S. April 19,
2012.
[Link] (Accessed
August 24, 2016).
133. Anon. Mylan confirms first-to-file patent challenge
relating
to
Canasa.
July
11,
2013.
[Link]
(Accessed August 27,
2016).
134. Voreacos D, Decker S. Teva wont sell generic
Vytorin until 2017 under accord. July 8, 2011.
[Link] (Accessed August 22, 2016).
135. Anon.
Sunovion Pharmaceuticals files patent
infringement lawsuits regarding Latuda. January 14,
2015.
[Link] (Accessed August 22,
2016).
136. Anon. Aurobindo Pharma lands in patient litigation
cases
in
USA.
April
28,
2014.
[Link] (Accessed August 26, 2016).

More. . .
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(Professional Resource #320947: Page 20 of 21)

137. Keshavan M. Which drugs are going off-patent in

2016? January 4, 2016. [Link]
/2016/01/drugs-off-patent/?rf=1. (Accessed August
29, 2016).
138. Westney A. Mylan hit with IP suit over generic
cholesterol
drug.
April
18,
2014.
[Link]
(Accessed August 26, 2016).
139. Anon. Natco settles suit over Tamiflu. December
15,
2015.
[Link]
natco-settles-suit-over-tamiflu/178756/.
(Accessed
September 9, 2016).
140. Anon. Merck wins U.S. Zetia (ezetimibe)/Vytorin
(ezetimibe/simvastatin) patent infringement lawsuit.
April 27, 2012.
[Link]
/press-release/corporate-news/merck-wins-us-zetiaezetimibe-vytorin-ezetimibesimvastatin-patent-infri.
(Accessed August 22, 2016).
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Tarceva.
July
25,
2013.
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(Accessed August 26, 2016).
142. Broady G. Genzyme sues to stop generic leukemia
treatment.
July
30,
2012.
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August 22, 2016).
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Q4.
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over its top-selling cancer med. July 13, 2016.
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145. Anon.
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March
29,
2016.
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(Accessed August 24, 2016).
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Tevas new Copaxone formula loses two defenses
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(Accessed August 26, 2016).
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[Link]
(Accessed
August 26, 2016).
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(pralatrexate injection) ANDA patent litigation. July
13, 2016. [Link] (Accessed August 26, 2016).
150. Food and Drug Administration. ANDA approval
letter.
Mylan generic Cambia.
May 2, 2016.
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August 31, 2016).
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Apotex generic Sprycel.
June 10,
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August 31, 2016).
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August 31, 2016).
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30,
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156. Anon. Strides Shasun receives USFDA tentative
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June 1, 2016.
[Link]
fda_tentative_approval_for_roflumilast_tablets.pdf.
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157. Anon. Vanda patents found valid and infringed in
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August 25, 2016.
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August 31, 2016).
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biosimilar of Amgens Enbrel.
[Link]

(Accessed August 31, 2016).

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(Professional Resource #320947: Page 21 of 21)

Cite this document as follows: Professional Resource, Anticipated Availability of First-Time Generics. Pharmacists
Letter/Prescribers Letter. September 2016.

Evidence and Recommendations You Can Trust

3120 West March Lane, Stockton, CA 95219 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright 2016 by Therapeutic Research Center

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Detail-Document #250801
This Detail-Document accompanies the related article published in

PHARMACISTS LETTER / PRESCRIBERS LETTER

August 2009 ~ Volume 25 ~ Number 250801

Angiotensin Receptor Blocker (ARB) Antihypertensive Dose Comparison

(Full update February 2012)
NOTE: When switching products consider indication, liver function, renal function, other medical conditions, and allergies. Dose equivalencies are
approximate; individual responses may vary. Monitor blood pressure, potassium, and renal function.
Abbreviations: BID=twice daily; MI=myocardial infarction; QD=once daily
Drug
Comparable dose based on therapeutic interchange studies, comparative
clinical trials, and manufacturers recommended dosing for hypertension.1-19,21,22,23
*Shaded area denotes manufacturers recommended starting dose for hypertension*
(See footnotes regarding lower doses)

Azilsartan (Edarbi)

40 mg QDc

40 mg QDc

40 mg QDc

40 mg QDc

Candesartan (Atacand)

4 mg QDa

8 mg QD or
divided BID

16 mg QD or
divided BIDb

16 mg QD or
divided BIDb to
32 mg QD or
divided BID

---

Eprosartan (Teveten)

400 mg QD

600 mg QDL

75 mg QDc

150 mg QD

800 mg QD or
divided BIDd
300 mg QD

---

Irbesartan (Avapro)

800 mg QD or
divided BIDd
300 mg QD

Losartan (Cozaar)

25 mg QDe

Olmesartan (Benicar)

10 mg QD

50 mg QD or
divided BIDn
20 mg QDf

Telmisartan (Micardis)

20 mg QD

40 mg QDg

Valsartan (Diovan)

40 mg QD or
20 mg BIDh

80 mg QDj or
40 mg BIDi,m

100 mg QD or
divided BIDn
20 mg QDf to
40 mg QD
40 mg QDg to
80 mg QD
160 mg QDj

80 mg QD

---

---

---

40 mg QD

---

80 mg QD

---

320 mg QDk,m

--More. . .

Copyright 2009 by Therapeutic Research Center

Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link]

(Detail-Document #250801: Page 2 of 3)

a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
L.
m.
n.

Starting dose for heart failure.3

Consider lower starting dose for moderate hepatic impairment or volume-depleted patients.3
Starting dose for volume/sodium-depleted patients.6,17
Maximum dose is 600 mg QD in moderate or severe renal impairment.5
Starting dose for volume/sodium-depleted patients or patients with (or with a history of) hepatic impairment.7
Consider lower starting dose for volume-depleted patients.8
Use lower starting dose for hepatic impairment or volume/sodium-depleted patients.9
Starting dose post-MI.10
Starting dose for heart failure.10
Recommended initial dose for hypertension monotherapy in patients who are not volume-depleted. Dose cautiously in hepatic or severe renal
impairment.10
Divide BID for post-MI and heart failure indications.10
Recommended initial dose for monotherapy in patients who are not volume-depleted.5
Dose cautiously in hepatic or severe renal impairment.10
Losartan may not control blood pressure as well as other ARBs.20 BID dosing may improve blood pressure control.7

Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and Internet links in this article were current as of the date of publication.

More. . .
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[Link] ~ [Link]

(Detail-Document #250801: Page 3 of 3)

Project Leader in preparation of this DetailDocument: Melanie Cupp, Pharm.D., BCPS

References
1.

2.

3.
4.

5.

6.

7.
8.
9.

10.

11.

12.

13.

Zannad F, Fay R. Blood pressure-lowering efficacy

of olmesartan relative to other angiotensin II receptor
antagonists: an overview of randomized controlled
studies. Fundam Clin Pharmacol 2007;21:181-90.
Sease J, Williams AM.
Equivalent doses in
irbesartan, valsartan, and losartan identified through
formulary switch at a Veterans Affairs medical
center. Formulary 2008;43:14-20.
Product information for Atacand. AstraZeneca LP.
Wilmington, DE 19850. April 2011.
Puig JG, Lopez MA, Bueso TS, et al. Clinical profile
of eprosartan. Cardiovasc Drugs Ther 2002;16:5439.
Product information for Teveten.
Abbott
Laboratories. North Chicago, IL 60064. December
2011.
Product information for Avapro.
Bristol-Myers
Squibb Company. Princeton, NJ 08543. January
2012.
Product information for Cozaar. Merck & Co., Inc.
Whitehouse Station, NJ 08889. November 2011.
Product information for Benicar. Daiichi Sankyo, Inc.
Parsippany, NJ 07054. June 2011.
Product information for Micardis.
Boehringer
Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT
06877. January 2012.
Product information for Diovan.
Novartis
Pharmaceuticals Corporation. East Hanover, NJ
07936. January 2012.
Asmar R. Targeting effective blood pressure control
with angiotensin receptor blockers. Int J Clin Pract
2006;60:315-320.
Elliott WJ, Calhoun DA, DeLucca PT, et al. Losartan
versus valsartan in the treatment of patients with mild
to moderate essential hypertension: data from a
multicenter, randomized, double-blind, 12-week trial.
Clin Ther 2001;23:1166-79.
Nakayama S, Watada Hm Mita T, et al. Comparison
of effects of olmesartan and telmisartan on blood
pressure and metabolic parameters in Japanese
early-stage type-2 diabetes with hypertension.
Hypertens Res 2008;31:7-13.

14. Sasaki T, Noda Y, Yasuoka Y, et al. Comparison of

the effects of telmisartan and olmesartan on home
blood pressure, glucose, and lipid profiles in patients
with hypertension, chronic heart failure, and
metabolic syndrome. Hypertens Res 2008;31;921-9.
15. Whittaker A. A review of olmesartan medoxomila
new angiotensin II blocker.
Br J Cardiol
2005;12;125-9.
16. Brunner HR, Stumpe KO, Januszewicz A.
Antihypertensive efficacy of olmesartan medoxomil
and candesartan cilexetil assessed by 24-hour
ambulatory blood pressure monitoring in patients
with essential hypertension.
Clin Drug Investig
2003;23:419-30.
17. Product
information for
Edarbi.
Takeda
Pharmaceuticals America, Inc. Deerfield, IL 60015.
December 2011.
18. Bakris GL, Sica D, Weber M, et al. The comparative
effects of azilsartan medoxomil and olmesartan on
ambulatory and clinic blood pressure.
J Clin
Hypertens 2011;13:81-8.
19. White WB, Weber MA, Sica D, et al. Effects of the
angiotensin receptor blocker azilsartan medoxomil
versus olmesartan and valsartan on ambulatory and
clinic blood pressure in patients with stages 1 and 2
hypertension. Hypertension 2011;57:413-20.
20. VA/DoD drug class review. Angiotensin II receptor
antagonists (AIIRAs).
Update February 2010.
[Link]
20Class%20Reviews/Angiotensin%20II%20Receptor
%20Antagonists,%20Drug%20Class%[Link].
(Accessed February 13, 2012).
21. Smith DH. Comparison of angiotensin II type 1
receptor antagonists in the treatment of essential
hypertension. Drugs 2008;68:1207-25.
22. Giles TD, Oparil S, Silfani TN, et al. Comparison of
increasing doses of olmesartan medoxomil, losartan
potassium, and valsartan in patients with essential
hypertension. J Clin Hypertension 2007;9:187-95.
23. Smith DH, Dubiel R, Jones M. Use of 24-hour,
ambulatory blood pressure monitoring to assess
antihypertensive efficacy:
a comparison of
olmesartan
medoxomil,
losartan
potassium,
valsartan, and irbesartan. Am J Cardiovasc Drugs
2005;5:41-50.

Cite this Detail-Document as follows: Angiotensin receptor blocker (ARB) antihypertensive dose comparison.
Pharmacists Letter/Prescribers Letter 2009 (Full update February 2012);25(8):250801.

Evidence and Advice You Can Trust

3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright 2009 by Therapeutic Research Center

Subscribers to Pharmacists Letter and Prescribers Letter can get Detail-Documents, like this one, on any
topic covered in any issue by going to [Link] or [Link]

Detail-Document #260301
This Detail-Document accompanies the related article published in

PHARMACISTS LETTER / PRESCRIBERS LETTER

March 2010 ~ Volume 26 ~ Number 260301

Comparison of Angiotensin Receptor Blockers

(Full update February 2012)
Abbreviations: ACEI = angiotensin-converting enzyme inhibitor; CHF = congestive heart failure; CrCl = creatinine clearance; CV = cardiovascular;
DM = diabetes mellitus; HCT = hydrochlorothiazide; HTN = hypertension; LVH = left ventricular hypertrophy; MI = myocardial infarction
Medication
Initial Dosea
Maintenance Dosea
FDAClinical Benefit
How Supplied/CostL
a,h
Approved
in
a
Indication
Azilsartan
HTN: 80 mg once daily23,f
80 mg once daily23,f
Hypertension
40, 80 mg
(Edarbi)
$82.66 (80 mg once daily)
With chlorthalidone
(Edarbyclor; not for
volume-depleted patients):
40/12.5, 40/2527

Candesartan
(Atacand)

HTN: 16 mg once daily1,b

HTN:
8-32 mg daily in one
or two divided doses1

Hypertension1
Heart Failure1

CHF: Reduces risk

of CV death or CHF
hospitalization1

CHF: 4 mg once daily1,b

CHF: 32 mg once
daily1

Diabetic retinopathy:
reduces incidence
(type 1 DM) and
improves mild to
moderate retinopathy
(type 2 DM)2,3
Nephropathy (type 2
DM): reduces
microalbuminuria14

4, 8, 16, 32 mg1
$104.99 (32 mg once
daily)
With HCT (Atacand HCT;
indicated for HTN only;
not for initial therapy; not
recommended if CrCl
<30 mL/min): 16/12.5,
32/12.5,
32/25 mg4

More. . .
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[Link] ~ [Link]

(Detail-Document #260301: Page 2 of 7)

Medication

Initial Dosea

Maintenance Dosea

Eprosartan
(Teveten)

600 mg once daily5,c

400-800 mg daily in
one or two divided
doses5

Irbesartan
(Avapro)

HTN: 150 mg once daily7,d

HTN: 150-300 mg
once daily7
Nephropathy (type 2
DM): 300 mg once
daily7

Losartan
(Cozaar, generics)

HTN: 50 mg once daily9,e

HTN with LVH: 50 mg once

daily9,e
Nephropathy (type 2 DM):
50 mg once daily9,e

Continued

CHF:
12.5 mg once daily (not
currently taking an ARB) or
25 mg once daily (switching

FDAApproved
Indicationa
Hypertension5

How Supplied/CostL

Clinical Benefit
ina,h

400, 600 mg5

$98.66 (600 mg once
daily)

Hypertension7
Nephropathy
(type 2 DM)7

Nephropathy (type 2
DM): reduces rate of
progression7

With HCT (Teveten HCT;

not for initial therapy):
600/12.5, 600/25 mg6
75, 150, 300 mg7
$108 (300 mg once daily)
With HCT (Avalide;
indicated for HTN only;
not for volume-depleted
patients; not recommended
if CrCl <30 mL/min):
150/12.5,
300/12.58

HTN:
25-100 mg daily in
one or two divided
doses9

Hypertension9

HTN/LVH:
50-100 mg once daily
(plus HCT if
needed)9

Hypertension
with LVH9

Nephropathy (type 2
DM): 100 mg once
daily9

Nephropathy
(type 2 DM)9

CHF: Reduces risk

of CV death or CHF
hospitalization;10
mortality similar to
captopril34

HTN with LVH:

reduces stroke risk
(may not benefit
African-Americans)9

25, 50, 100 mg9

$79.55 (100 mg once
daily)
With HCT (Hyzaar;
indicated for HTN and
HTN with LVH only; not
for volume-depleted
patients; not recommended
if CrCl <30 mL/min):
50/12.5, 100/12.5,
100/25 mg11

More. . .
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[Link] ~ [Link]

(Detail-Document #260301: Page 3 of 7)

Medication

Initial Dosea

Maintenance Dosea

Losartan, cont.

from another ARB)10

(Off-label use)

CHF: 150 mg once

daily10 (Off-label)

Olmesartan
(Benicar)

20 mg once daily12,g

20-40 mg once
daily12

FDAApproved
Indicationa

Hypertension12

How Supplied/CostL

Clinical Benefit
ina,h
Nephropathy (type 2
DM): reduces rate of
progression9
Type 2 DM: delays
onset of
microalbuminuria,
but with increased
risk of fatal CV
events among
patients with
coronary artery
disease28

5, 20, 40 mg12
$129.32 (40 mg once
daily)
With HCT (Benicar HCT;
not for initial therapy; not
recommended if CrCl <30
mL/min): 20/12.5,
40/12.5,
40/25 mg13
With amlodipine (Azor):
5/20, 10/20, 5/40,
10/40 mg21
With HCT and amlodipine
(Tribenzor; not for initial
therapy; not for volumedepleted patients; avoid if
CrCl <30 mL/min):
20/5/12.5, 40/5/12.5,
40/5/25, 40/10/12.5,
40/10/25 mg22

Telmisartan
(Micardis)
Continued

HTN: 40 mg once daily15,i

CV risk reduction (in patients
unable to take ACE

HTN: 40-80 mg once Hypertension15

daily15
CV risk
reduction in

High CV risk:
reduces risk of CV
events15

20, 40, 80 mg15

$108.65 (80 mg once
daily)
More. . .

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[Link] ~ [Link]

(Detail-Document #260301: Page 4 of 7)

Medication

Initial Dosea

Maintenance Dosea

Telmisartan, cont.

inhibitors):
80 mg once daily15,i

CV risk reduction:
80 mg once daily15

FDAApproved
Indicationa
patients unable
to take ACEI15

Clinical Benefit
ina,h

How Supplied/CostL

Nephropathy (type 2
DM): reduces
microalbuminuria,16
slows progression as
well as enalapril,32
and reduces
proteinuria in patients
with HTN29,30

With HCT (Micardis HCT;

indicated for HTN only;
not for initial therapy; not
for volume-depleted
patients; not
recommended if CrCl
<30 mL/min): 40/12.5,
80/12.5, 80/25 mg17

Hemodialysis
patients with CHF:
added to ACEI,
reduces all-cause and
CV mortality, and
heart failure
hospitalization24

Valsartan
(Diovan)

40, 80, 160, 320 mg18

HTN: 80-160 mg once

daily18,j,k

HTN: 80-320 mg
once daily18

Hypertension

CHF: reduces
hospitalization18

CHF: 40 mg twice daily18,k

CHF: 40-160 mg
twice daily (target
160 mg twice daily)18

Heart Failure
(Class II to IV)

Post-MI: 20 mg twice daily18,k

Post-MI: 20-160 mg
twice daily (target
160 mg twice daily)18

Post-MI with
left ventricular
dysfunction/
failure

Post-MI with left

ventricular
dysfunction/failure:
reduces CV
mortality18

$128 (320 mg once daily)

Continued

Nephropathy (type 2
DM): reduces
microalbuminuria,19
and proteinuria in
patients with HTN30

With HCT (Diovan HCT;

indicated for HTN only;
not for volume-depleted
patients; not recommended
if CrCl <30 mL/min.):
80/12.5, 160/12.5, 160/25,
320/12.5, 320/25 mg20
With amlodipine (Exforge;
indicated for HTN only):
5/160, 10/160, 5/320,

More. . .
Copyright 2010 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link]

(Detail-Document #260301: Page 5 of 7)

Medication

Valsartan, cont.

Initial Dosea

Maintenance Dosea

FDAApproved
Indicationa

Clinical Benefit
ina,h

How Supplied/CostL

HTN with high CV

risk: reduces CV
morbidity/mortality
about as well as
amlodipine33

10/320 mg25
With amlodipine and HCT
(Exforge HCT; indicated
for HTN only; not for
initial therapy; not for
volume-depleted patients;
avoid if CrCl
<30 mL/min): 5/160/12.5,
10/160/12.5, 5/160/25,
10/160/25, 10/320/25 mg26
With aliskiren (Valturna;
not for volume-depleted
patients): 150/160,
300/320 mg31

a. Indications, dosing, and clinical benefit for adult patients.

b. Consider lower starting dose for moderate hepatic impairment or volume-depleted patients.1
c. Recommended initial dose for monotherapy in patients who are not volume-depleted. Do not exceed 600 mg daily in moderate or severe renal
impairment.5
d. Initial dose of 75 mg once daily recommended for volume/sodium-depleted patients.7
e. Starting dose for volume/sodium-depleted patients or patients with (or with a history of) hepatic impairment is 25 mg once daily.9
f. Starting dose for volume/sodium-depleted patients is 40 mg once daily.23
g. Consider lower starting dose for volume-depleted patients.12
h. Evidence level A; high-quality randomized controlled trials.
i. Use lower starting dose for hepatic impairment or volume/sodium-depleted patients.15
j. Recommended initial dose for monotherapy in patients who are not volume-depleted.18
k. Dose cautiously in hepatic or severe renal impairment.18
L. Cost is for 30-day supply of brand (or generic, if available), per [Link] at time of writing.
Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and Internet links in this article were current as of the date of publication.
More. . .
Copyright 2010 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link]

(Detail-Document #260301: Page 6 of 7)

Levels of Evidence
In accordance with the trend towards Evidence-Based
Medicine, we are citing the LEVEL OF EVIDENCE
for the statements we publish.
Level
A

C
D

Definition
High-quality randomized controlled trial (RCT)
High-quality meta-analysis (quantitative
systematic review)
Nonrandomized clinical trial
Nonquantitative systematic review
Lower quality RCT
Clinical cohort study
Case-control study
Historical control
Epidemiologic study
Consensus
Expert opinion
Anecdotal evidence
In vitro or animal study

Adapted from Siwek J, et al. How to write an evidence-based clinical

review article. Am Fam Physician 2002;65:251-8.

Project Leader in preparation of this DetailDocument: Melanie Cupp, Pharm.D., BCPS

References
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Product information for Atacand. AstraZeneca LP.

Wilmington, DE 19850. April 2011.
2. Sjlie AK, Klein R, Porta M, et al.
Effect of
candesartan on progression and regression of
retinopathy in type 2 diabetes (DIRECT-Protect 2): a
randomised placebo-controlled trial.
Lancet
2008;372:1385-93.
3. Chaturvedi N, Porta M, Klein R, et al. Effect of
candesartan on prevention (DIRECT-Prevent 1) and
progression (DIRECT-Protect 1) of retinopathy in
type 1 diabetes: randomised, placebo-controlled
trials. Lancet 2008;372:1394-402.
4. Product information for Atacand HCT. AstraZeneca
LP. Wilmington, DE 19850. April 2011.
5. Product information for Teveten.
Abbott
Laboratories. North Chicago, IL 60064. January
2012.
6. Product information for Teveten HCT.
Abbott
Laboratories. North Chicago, IL 60064. January
2012.
7. Product information for Avapro.
Bristol-Myers
Squibb Sanofi Synthelabo Partnership. New York,
NY 10016. January 2012.
8. Product information for Avalide.
Bristol-Myers
Squibb Sanofi Synthelabo Partnership. New York,
NY 10016. January 2012.
9. Product information for Cozaar. Merck & Co., Inc.
Whitehouse Station, NJ 08889. November 2011.
10. Konstam MA, Neaton JD, Dickstein K, et al. Effects
of high-dose versus low-dose losartan on clinical
outcomes in patients with heart failure (HEAAL
study): a randomised, double-blind trial. Lancet
2009;374:1840-8.

11. Product information for Hyzaar. Merck & Co., Inc.

Whitehouse Station, NJ 08889. November 2011.
12. Product information for Benicar. Daiichi Sankyo, Inc.
Parsippany, NJ 07054. June 2011.
13. Product information for Benicar HCT.
Daiichi
Sankyo, Inc. Parsippany, NJ 07054. May 2011.
14. Mogensen CE, Neldam S, Tikkanen I, et al.
Randomised controlled trial of dual blockade of
renin-angiotensin
system
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with
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BMJ
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15. Product information for Micardis.
Boehringer
Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT
06877. January 2012.
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of transition from incipient to overt nephropathy with
telmisartan in patients with type 2 diabetes.
Diabetes Care 2007;30:1577-8.
17. Product information for Micardis HCT. Boehringer
Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT
06877. January 2012.
18. Product information for Diovan.
Novartis
Pharmaceuticals Corp. East Hanover, NJ 07936.
January 2012.
19. Viberti G, Wheeldon NM, MicroAlbuminuria
Reduction with VALsartan (MARVAL) study
investigators.
Microalbuminuria reduction with
valsartan in patients with type 2 diabetes mellitus: a
blood pressure-independent effect.
Circulation
2002;106:672-8.
20. Product information for Diovan HCT.
Novartis
Pharmaceuticals Corp. East Hanover, NJ 07936.
January 2012.
21. Product information for Azor. Daiichi Sankyo, Inc.
Parsippany, NJ 07054. November 2011.
22. Product information for Tribenzor. Daiichi Sankyo,
Inc. Parsippany, NJ 07054. November 2011.
23. Product
information
for
Edarbi.
Takeda
Pharmaceuticals America, Inc. Deerfield, IL 60015.
December 2011.
24. Cice G, Di Benedetto A, Dlsa S, et al. Effects of
telmisartan added to angiotensin-converting enzyme
inhibitors on mortality and morbidity in hemodialysis
patients with chronic heart failure a double-blind,
placebo-controlled trial.
J Am Coll Cardiol
2010;56:1701-8.
25. Product information for Exforge.
Novartis
Pharmaceuticals Corp. East Hanover, NJ 07936.
January 2012.
26. Product information for Exforge HCT.
Novartis
Pharmaceuticals Corp. East Hanover, NJ 07936.
January 2012.
27. Product information for Edarbyclor.
Takeda
Pharmaceuticals America, Inc. Deerfield, IL 60015.
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28. Haller H, Ito S, Izzo JL Jr, et al. Olmesartan for the
delay or prevention of microalbuminuria in type 2
diabetes. N Engl J Med 2011;364:907-17.

More. . .
Copyright 2010 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
[Link] ~ [Link]

(Detail-Document #260301: Page 7 of 7)

29. Bakris G, Burgess E, Weir M, et al. Telmisartan is

more effective than losartan in reducing proteinuria in
patients with diabetic nephropathy.
Kidney Int
2008;74:364-9.
30. Galle J, Schwedhelm E, Pinnetti S, et al.
Antiproteinuric effects of angiotensin receptor
blockers:
telmisartan versus valsartan in
hypertensive patients with type 2 diabetes mellitus
and overt nephropathy. Nephrol Dial Transplant
2008;23:3174-83.
31. Product information for Valturna.
Novartis
Pharmaceuticals Corp. East Hanover, NJ 07936.
October 2011.
32. Barnett AH, Bain SC, Bouter P, et al. Angiotensinreceptor
blockade
versus converting-enzyme
inhibition in type 2 diabetes and nephropathy. N
Engl J Med 2004;351:1952-61.

33. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in

hypertensive patients at high cardiovascular risk
treated with regimens based on valsartan or
amlodipine: the VALUE randomised trial. Lancet
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34. Pitt B, Poole-Wilson PA, Segal R, et al. Effect of
losartan compared with captopril on mortality in
patients with symptomatic heart failure: randomized
trialthe Losartan Heart Failure Survival Study
ELITE II. Lancet 2000;355:1582-7.

Cite this Detail-Document as follows:

Comparison of angiotensin receptor blockers.
Letter/Prescribers Letter 2010 (Full update February 2012);26(3):260301.

Pharmacists

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