Anticipated Availability of First-Time Generics

This Clinical Resource gives subscribers
additional insight related to the Recommendations published in
January 2017 ~ Resource #330146
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
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default.htm
Branda Generic Name Generic Manufacturer(s)b,1 Anticipated Availabilityc

(Manufacturer)
Aggrenox Aspirin/Dipyridamole Teva Generic now available

(Boehringer Ingelheim)
Ammonul Sodium benzoate/Sodium Trigen (Ailex), Zydus (Navinta) Generic now available
(Medicis) phenylacetate
Asacol HD Mesalamine delayed-release tablet Zydus Generic now available (authorized
(Warner Chilcott) generic)
Azor Olmesartan/Amlodipine Ajanta, Macleods, Teva Generic now available
(Daiichi Sankyo)
Benicar/Benicar HCT Olmesartan/Olmesartan HCTZ Mylan Generic now available
(Daiichi Sankyo)
Bloxiverz Neostigmine methylsulfate West-Ward (Eurohealth) Generic now available
(Eclat) 5 mg/10 mL
CellCept Mycophenolate mofetil Par Generic now available
(Roche Palo) hydrochloride injection
Cordran Flurandrenolide 0.05% lotion Perrigo Generic now available
(Aqua)
Cordran SP Flurandrenolide 0.05% cream Cintex (Teligent) Generic now available
(Aqua)
Cubicin Daptomycin Fresenius Kabi (Crane), Teva Generic now available
(Cubist)
Delalutin Hydroxyprogesterone caproate ANI Pharmaceuticals (McGuff/Aspen) Generic now available
(Bristol-Myers Squibb) injection (brand discontinued)
Diabeta Glyburide Impax (CorePharma) Generic now available
(Sanofi Aventis)
More. . .
Copyright 2017 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
PharmacistsLetter.com ~ PrescribersLetter.com ~ PharmacyTechniciansLetter.com ~ NursesLetter.com
(Clinical Resource #330146: Page 2 of 23)

(Manufacturer)
Doryx Doxycycline hyclate delayed- Heritage, Mylan, Teva (Actavis Elizabeth) Generic now available
(Mayne) release tablet
Edecrin Ethacrynic acid 25 mg tablet Edenbridge Generic now available
(Aton)
Emend Aprepitant capsule Sandoz Generic now available
(Merck)
Epzicom Abacavir sulfate/Lamivudine Lupin, Teva Generic now available
(GlaxoSmithKline) 600 mg/300 mg tablet
Exalgo Hydromorphone extended-release Teva (Actavis) Generic now available
(Mallinckrodt) tablet 32 mg
Fenoglide Fenofibrate tablet 40 mg, 120 mg Mylan Generic now available
(Santarus)
Fusilev Levoleucovorin 50 mg/vial West-Ward Generic now available
(Spectrum)
Glyset Miglitol tablets Sun (Orient) Generic now available
(Pharmacia & Upjohn)
Imitrex Sumatriptan nasal spray Lannett Generic now available
(GlaxoSmithKline)
Lantus Insulin glargine (Basaglar Eli Lilly/Boehringer Ingelheim Biosimilari now available
(Sanofi-Aventis) [biosimilari])
Latisse Bimatoprost 0.03% Sandoz Generic now available
(Allergan)
Lodosyn Carbidopa Alvogen, Amerigen, Edenbridge Generic now available
(Aton)
Naftin Naftifine 2% cream Taro Generic now available
(Merz)
More. . .

(Manufacturer)
Naropin Ropivacaine 40 mg/20 mL, 40 mg/20 mL, 150 mg/20 mL: Aurobindo, Generic now available
(Fresenius Kabi) 200 mg/100 mL, 100 mg/20 mL, Hospira, Sagent
100 mg/10 mL, 150 mg/30 mL, 200 mg/100 mL, 100 mg/20 mL,
150 mg/20 mL, 200 mg/20 mL 200 mg/20 mL: Aurobindo
100 mg/10 mL: Aurobindo, Hospira
150 mg/30 mL: Aurobindo, Hospira, Sagent,
Sandoz (Navinta)
Nasonex Mometasone nasal spray Apotex Generic now available
(Merck)
Neoprofen Ibuprofen lysine X-Gen (Exela) Generic now available
(Recordati Rare)
Nilandron Nilutamide ANI Pharmaceuticals Generic now available
(Concordia)
Nuvigil Armodafinil Breckenridge (Natco), Lupin, Mylan Generic now available
(Teva)
Oxistat Oxiconazole 1% cream Taro, Welgo (Taro) Generic now available
(Fougera)
Remicade Infliximab (Inflectra [biosimilari]) Hospira (Pfizer) Biosimilari now available
(Janssen)
Seroquel XR Quetiapine extended-release tablet Accord Generic now available
(AstraZeneca)
Tamiflu Oseltamivir capsules Alvogen (Natco) Generic now available
(Genentech)
Tikosyn Dofetilide Mayne (Tiger) Generic now available
(Pfizer)
Tribenzor Olmesartan/Amlodipine/HCTZ Par, Teva Generic now available
(Daiichi Sankyo)
Trilipix Fenofibric acid 45 mg, 135 mg Impax, Lupin, Mylan, Par (Anchen), Teva Generic now available
(Abbvie) delayed-release capsule (Actavis)
Trizivir Abacavir, lamivudine, zidovudine Lupin Generic now available
(GlaxoSmithKline)
More. . .

(Manufacturer)
Vagifem Estradiol vaginal tablet (Yuvafem) Amneal Generic now available

(Novo Nordisk)
Voltaren Diclofenac 1% gel Amneal, Avkare (Amneal) Generic now available
(GlaxoSmithKline)
Zegerid Omeprazole/Sodium bicarbonate Ajanta, Aurobindo (Aurolife), Dr. Reddys, Generic now available
(Santarus) capsule Northstar Rx (Ajanta), Par
Zegerid Omeprazole/Sodium bicarbonate Ajanta, Par Generic now available
(Santarus) suspension
Zegerid OTC Omeprazole/Sodium bicarbonate Perrigo (CVS, Walgreens) Generic now available
(Bayer) capsule
Ziana Clindamycin phosphate 1.2%/ Teva (Actavis) Generic now available
(Medicis) Tretinoin 0.025%
Zovia 1/50E-28 Ethynodiol diacetate/ethinyl Jai (Mylan) Generic now available
(Actavis) estradiol
Azilect Rasagiline mesylate tablet Alkem, Apotex, Mylan, Orchid, Sandozf,30 February 201730
(Teva)
Minastrin 24 Fe Ethinyl estradiol/Norethindrone Jai, Lupin (Mibelas) March 2017151
(Warner Chilcott) acetate/Ferrous fumarate
Pristiq Desvenlafaxine succinate Actavis, Alembic, Mylan, Lupin, Roxane, March 201733
(Wyeth) extended-release tablet Sandoz, Wyeth
Vytorin Ezetimibe/Simvastatin Impax, Mylan, Tevaf,134 April 201728,134
(Merck)
Zetia Ezetimibe Actavis, Glenmark, Mylan, Sandoz, Teva April 201728
(Merck)
Strattera Atomoxetine Apotex, Aurobindo, Dr. Reddys, Glenmark, May 2017
(Lilly) Hetero, Mylan, Sandoz, Sun, Zydus
Reyataz Atazanavir Aurobindo, Emcure, Matrix, Teva July 2017 (or earlier)83
(Bristol-Myers Squibb)
Adcirca Tadalafil Aurobindo, Synthon November 201718
(Lilly)
Prezista Darunavir tablet Hetero, Lupin, Mylan, Teva November 201779
(Janssen)
More. . .

(Manufacturer)
Virazole Ribavirin inhalation solution Navinta November 2017 (or earlier)d,21

(Valeant)
Sustiva Efavirenz Tablet: Aurobindo, Cipla, Emcure, Hetero, December 201724
(Bristol-Myers Squibb) Macleods, Matrix, Micro Labs, Mylan, Par,
Strides, Teva
Capsule: Aurobindo, Cipla, Micro Labs
Truvada Emtricitabine/Tenofovir Aurobindo, Cipla, Hetero, Lupin,f,25 Matrix, December 201725
(Gilead) disoproxil fumarate tablet Mylan,f,25 Strides Arcolab, Teva
Viagra Sildenafil Actavis, Ajanta, Amneal, Apotex, Aurobindo, December 2017 (or earlier)91,92
(Pfizer) Dr. Reddys, Hetero, Macleods, Mylan,
Rubicon
Viread Tenofovir disoproxil fumarate Aurobindo, Cipla, InvaGen, Lupin, Macleods, December 20178
(Gilead) tablet Matrix, Mylan, Pharmacare, Strides Arcolab,
Teva
Copaxone Glatiramer 40 mg/mL Dr. Reddys,h,94 Mylan,h,146 First half 2018146
(Teva) Momenta/Novartis,h,146 Sandozh,70
Solodyn Minocycline extended-release Apotex,h,117 Alkem, Aurobindo, Mylan, February 201824
(Medicis) tablet 55 mg, 65 mg, 80 mg, Sandoz, Sidmak, Sun, Teva
105 mg, 115 mg
Treximet Sumatriptan/Naproxen Alphapharm,f,102 Dr. Reddys, Mylan, Par, February 2018102
(Pozen) Tevaf,102
Factive Gemifloxacin tablet Orchid March 201829
(Cornerstone)
Sensipar Cinacalcet tablet Mylan, Teva March 201851
(Amgen)
Enbrel Etanercept Sandoz (biosimilari) April 2018 or later159
(Amgen)
Lexiva Fosamprenavir Lupin, Mylan, Ranbaxyf,130 June 2018130
(Vertex)
Remodulin Treprostinil injection Sandoz June 2018 (or earlier)126
(United Therapeutics)
More. . .

(Manufacturer)
Acanya Benzoyl peroxide 2.5%/ Actavis July 2018 (or earlier)87

(Valeant) Clindamycin phosphate 1.2%
Clolar Clofarabine Abon,h,142 Amneal,h,2 Mylan,f,12 Sun,h,101 July 2018 (or earlier)12
(Genzyme) Zydus
Latuda Lurasidone Accord, Actavis, Amneal, Aurobindo, July 2018 (or earlier)d,135
(Sunovion) Emcure, InvaGen, Lupin, MSN, Sun
Atripla Efavirenz/Emtricitabine/Tenofovir Aurobindo, Cipla, Hetero, Macleods, Matrix, August 2018 (or earlier)e,68
(Gilead) disoproxil fumarate Teva
Aloxi Palonosetron injection Akorn, Aurobindo, Dr. Reddys, Exela, September 2018 (or earlier)78
(Eisai) Fresenius Kabi, Sandoz, Teva
Fentora Fentanyl citrate buccal tablet Actavis,f,72 Impax,f,57 Mylan,f,89 Sandoz,f,106 October 2018 (or earlier)90
(Cephalon) Tevaf,90
Levitra Vardenafil tablet Macleods, Teva October 2018 (or earlier)e,10
(GlaxoSmithKline)
Staxyn Vardenafil orally disintegrating Actavis, Macleods, Par October 201840,96
(Bayer) tablet
Vesicare Solifenacin succinate Actavis, Teva October 201820
(Astellas)
Finacea Azelaic acid gel Glenmark November 2018 (or earlier)d,19
(Bayer)
Fortesta Testosterone gel Actavis November 2018
(Endo)
Lyrica Pregabalin Capsule: Actavis, Alembic, Alkem, Apotex, December 201850
(Pfizer) Aurobindo, Lupin, Macleods, Mylan, Sandoz,
Teva, Wockhardt
Oral solution: Apotex, Lupin, Novel
Rapaflo Silodosin Lupin December 2018 (or earlier)d,21
(Allergan)
Zyclara Imiquimod cream Actavisf,17 January 2019 (or earlier)17
(Medicis)
Gilenya Fingolimod Aurobindo, MSN, Torrentf, February 2019173
(Novartis)
More. . .

(Manufacturer)
Ranexa Ranolazine Lupin, Teva February 201981

(Gilead)
AzaSite Azithromycin 1% ophthalmic Mylan,f,13 Sandoz March 2019 (or earlier)e,13
(InSite Vision) solution
Emend Fosaprepitant injection Accord,h,53 Fresenius Kabi, Sandoz March 201935
(Merck)
Faslodex Fulvestrant Sandozf,144 March 2019 (or earlier)144
(AstraZeneca)
Exjade Deferasirox tablets for oral Actavis, Mylanh,11 April 2019 (or earlier)e,43
(Novartis) suspension
Sporanox Itraconazole solution Ferah,45 June 2019 (or earlier)d
(Janssen)
Uloric Febuxostat Alembic, Dr. Reddys,h,97 Hetero,h,97 Lupin,h,97 June 201916,47
(Takeda) Mylan, Ranbaxy,h,97 Roxane, Sunh,97
Ziagen Abacavir oral solution Hetero August 2019 (or earlier)d,21
(Viiv)
Edluar Zolpidem sublingual tablet Mylan, Par September 2019e,154,155
(Orexo)
Treanda Bendamustine 25 mg/vial and Accord, Breckinridge, Eagle, Glenmark, November 2019 (or earlier)111
(Teva) 100 mg/vial Hospira, InnoPharma, Sagentf,107
Zohydro Hydrocodone extended-release Actavis November 2019 (or earlier)d,171
(Recro) capsule
Daliresp Roflumilast Strides January 2020156
(AstraZeneca)
Namenda XR Memantine extended-release Amneal, Apotex, Lupin, Mylan, Sun, Teva,f,58 January 20203
(Forest) capsule Wockhardth,118
Silenor Doxepin Actavis, Mylan, Par, Zydus January 2020 (or earlier)39
(Somaxon)
Delzicol Mesalamine delayed-release Cadila,f,139 Mylan,h,115 Zydusf,109 March 2020 (or earlier)109,139
(Warner Chilcott) capsule
More. . .

(Manufacturer)
Vigamox Moxifloxacin ophthalmic solution Actavis, Akorn, Apotex, Lupin, Teva March 2020 (or earlier)e,6,178
(Alcon)
Chantix Varenicline Actavis, Apotex, Mylan, Teva May 2020 (or earlier)d,49
(Pfizer)
Dexilant Dexlansoprazole Impax,f,104 Par, TWif,93 June 2020104
(Takeda)
Lialda Mesalamine delayed-release tablet Allergan,f,42,145 Mylan,h,38 Zydush,76 June 202042,46,145,163
(Shire)
Kuvan Sapropterin Dr. Reddys,f Par Sometime after September 2020 (or
(BioMarin) earlier)176
Cialis Tadalafil Aurobindo, Alembic November 2020 (or earlier)d,21
(Eli Lilly)
Absorica Isotretinoin Actavisf,88 December 2020 (or earlier)88
(Ranbaxy)
Ofirmev Acetaminophen injection Fresenius Kabi, Perrigo (Paddock),31 Sandoz December 2020 (or earlier)31
(Mallinckrodt)
Sutent Sunitinib Mylan February 2021
(Pfizer)
Jevtana Cabazitaxel Accord, Actavis, BPI,h,170 Breckenridge,h,54 March 2021 (or earlier)d,170
(Sanofi Aventis) Fresenius Kabih,170
Diclegis Doxylamine/Pyridoxine Actavis June 2021 (or earlier)e,158
(Duchesnay)
Perforomist Formoterol inhalation solution Teva June 2021
(Mylan)
Bystolic Nebivolol Actavis,f,67 Alkem,f,67 Amerigen,f,67 September 2021 (or earlier)67
(Forest) Glenmark,f,63,67 Hetero,f,67 Indchemie,f,67
Torrentf,67
Emtriva Emtricitabine capsule Aurobindo, Cipla, Matrix September 2021 (or earlier)d,4
(Gilead)
Brovana Arformoterol Teva November 2021
(Sunovion)
More. . .

(Manufacturer)
Humira Adalimumab Amgen (biosimilari) 2022 (or earlier)d,162

(AbbVie)
Revlimid Lenalidomide Allerganf,23 March 202223
(Celgene)
Vimpat Lacosamide Tablet: Accord, Actavis, Alembic, Amneal, March 20225
(UCB) Aurobindo, Glenmark, MSN, Mylan, Sun
Oral solution: Amneal, Apotex, Glenmark
Zipsor Diclofenac potassium liquid-filled Actavis,f,95 Bionpharma March 2022 (or earlier)95
(Depomed) capsule
Alimta Pemetrexed Accord, APP, Emcure,h,69 Heritage,h,69 May 2022
(Lilly) Sandoz,h,56 Teva
Banzel Rufinamide Glenmark, Hetero,h,80 Lupin,h,80 Mylan, West- May 2022 (or earlier)48
(Eisai) Ward
Vimovo Naproxen/Esomeprazole Actavis,h,77 Anchen,h,77 Dr. Reddys, Lupin,h,77 May 2022 (or earlier)d,77
(Horizon) magnesium delayed-release tablet Mylanh,77
Viibryd Vilazodone Teva June 2022 (or earlier)d,21
(Forest)
Januvia Sitagliptin Actavis, Apotex, Mylan, Sandoz, Sun, Teva July 2022d,21,124
(Merck)
Janumet Sitagliptin/Metformin Actavis, Apotex, Sandoz July 2022d,21,124
(Merck)
Janumet XR Sitagliptin/Metformin extended- Anchen, Teva July 2022d,21,124
(Merck) release tablet
Toviaz Fesoterodine extended-release Actavis, Accord,f,108,141 Alembic, Amerigen, July 2022d,82,141,147
(Pfizer) tablet Amneal, Aurobindo, Cadila,f,108,141 Dr. Reddys,
Impax,f,108,141 Mylan,h,141,147 Lupin, Sandoz, Sun,
Wockhardt,f,82,141 Zydusf,108,141
Folotyn Pralatrexate Teva November 2022149
(Spectrum)
Effient Prasugrel Aurobindo, Hec Pharm,h,26 Mylan, Parh,148 January 2023 (or earlier)d
(Eli Lilly)
More. . .

(Manufacturer)
Vyvanse Lisdexamfetamine Actavis, Amneal, Mylan, Roxane, Sandoz February 202355

(Shire)
Suprep Magnesium sulfate anhydrous, Breckenridge, Paddock March 2023 (or earlier)d,174
(Braintree) potassium sulfate, sodium sulfate
Edurant Rilpivirine Strides Arcolab April 202365
(Janssen)
Gralise Gabapentin Actavis, Incepta,f,98 Zydusf,98 January 2024 (or earlier)62,98
(Depomed)
Livalo Pitavastatin Aurobindo, Lupin, Mylan,h,138 Zydush,136 February 2024 (or earlier)d
(Kowa)
Pataday Olopatadine 0.2% ophthalmic Actavis, Akorn, Apotex, Teva, Wockhardth,100 May 2024 (or earlier)d
(Alcon) solution
Namzaric Donepezil/Memantine Amnealf,160 January 2025160
(Forest)
Nucynta Tapentadol tablet Actavis, Alkem, Roxane June 2025164
(Depomed)
Nucynta ER Tapentadol extended-release Actavis June 2025164
(Depomed) tablet
Xyrem Sodium oxybate Ohm,f,153 Par,h,7 Ranbaxy,f,143 Roxane,h,7 December 2025143
(Jazz) Sun,f,153 Wockhardtf,143
Sprycel Dasatinib Apotex March 2026 (or earlier)e,152
Afinitor Everolimus Breckenridge,h,177 West-Ward May 2026 (or earlier)d,177
(Novartis)
Natazia Dienogest/estradiol valerate Actavis, Lupin,h,61 Teva May 2026 (or earlier)d,61,165
(Bayer)
Aplenzin Bupropion hydrobromide Actavis, Paddock,h,105 Parf,83 June 2026 (or earlier)e,83
(Valeant) extended-release tablet
Cambia Diclofenac potassium oral Par June 2026 (or earlier)e,150
(Depomed) solution 50 mg
Nuedexta Dextromethorphan/Quinidine Impax,f,116 Par, Sandoz,f,103 Wockhardtf,85 July 2026 (or earlier)85,103
(Avanir)
More. . .

(Manufacturer)
AndroGel 1.62% Testosterone Actavis,h,44 Perrigo October 2026 (or earlier)e,166

(AbbVie)
Ampyra Dalfampridine extended-release Accord, Actavis, Alkem, Alkem, Aurobindo, 2027 (or earlier)119,121,122
(Acorda) tablet Roxane, Mylan, Sun, Teva
Aveed Testosterone undecanoate Paddock March 2027 (or earlier)d,21
(Endo)
Lumigan Bimatoprost ophthalmic solution Actavis,f,123 Apotex, Hi-Tech,f,123 Lupin,f,123 June 2027123
(Allergan) 0.01% Sandoz
Epiduo Adapalene 0.1%/Benzoyl Actavis, Glenmark, Perrigo, Parf,131 July 2027(or earlier)131
(Galderma) peroxide 2.5%
Fanapt Iloperidone Inventia, Roxanef,157 November 2027157
(Vanda)
Nexavar Sorafenib Mylan December 2027 (or earlier)d,21
(Bayer)
Oracea Doxycycline 40 mg capsule Amneal, Lupin, Mylan December 2027 (or earlier)110
(Galderma)
Promacta Eltrombopag Hetero February 2028 (or earlier)d,21
(Novartis)
Canasa Mesalamine rectal suppository 1 g Mylan, Sandoz June 2028 (or earlier)d,133
(Aptali)
Prepopik Citric acid, magnesium oxide, Par October 2028 (or earlier)d,175
(Ferring) sodium picosulfate
Onglyza Saxagliptin Actavis,h,99 Amneal, Aurobindo, Par November 2028 (or earlier)d
Pennsaid Diclofenac sodium 2% solution Actavis, Amneal, Lupin, Perrigo (Paddock), January 2029 (or earlier)66
(Horizon) Taro
Colcrys Colchicine Actavis, Hikma,h,64 Par February 2029 (or earlier)d,64
(Takeda) (authorized generic available)
Lo Loestrin Fe Ethinyl estradiol/Norethindrone Glenmark, Jai (Mylan), Novast (Lo Larin FE) February 2029 (or earlier)e,32
(Actavis) acetate/Ferrous fumarate
Tygacil Tigecycline injection Fresenius Kabi, Sandoz February 202974 (authorized generic
(Wyeth) available)
More. . .

(Manufacturer)
Isentress Raltegravir tablet Hetero March 2029 (or earlier)d,21

(Merck)
Quartette Levonorgestrel/Ethinyl estradiol Actavis,h,120 Lupin (Fayosim) March 2029 (or earlier)d,120
(Teva)
Moxeza Moxifloxacin ophthalmic solution Actavis,h,125 Lupin May 2029 (or earlier)d,6,125
(Alcon)
Qsymia Phentermine/Topiramate Actavis,h,41 Tevah,41 June 2029 (or earlier)d,41
(Vivus) extended-release capsule
Onexton Benzoyl peroxide 3.75%/ Allergan,h,113 Taro August 2029 (or earlier)d
(Dow) Clindamycin phosphate 1.2%
Savella Milnacipran Amneal, Apotex,h,14 First Time US September 2029 (or earlier)127,168
(Forest) Generics,h,167 Glenmark,f,127 Hetero,h,14 Lupin, (may be authorized generic)
Mylan, Par, Ranbaxy,h,14 Sandozh,52
Tykerb Lapatinib Natco September 2029 (or earlier)d,21
(Novartis)
Travatan Z Travoprost 0.004% ophthalmic Apotex, Mylan, Par October 2029 (or earlier)d,128
(Alcon) solution
Tivicay Dolutegravir Aurobindo December 2029
(Viiv)
Suboxone Buprenorphine/Naloxone Actavis,h,86 Parh,169 March 2030d
(Reckitt Benckiser) sublingual film
Zorvolex Diclofenac liquid-filled capsules Lupin April 2030 (or earlier)d,21
(Iroko)
Giazo Balsalazide 1.1 g tablet Apotex,h,129 Lupin, Mylan, Par June 2031 (or earlier)e,75
(Valeant)
Mirvaso Brimonidine tartrate gel Perrigoh,161 June 2031 (or earlier)d
(Galderma)
Multaq Dronedarone Actavis, Alkem, Glenmark June 2031 (or earlier)d,21
(Sanofi-Aventis)
Contrave Bupropion/Naltrexone sustained Actavish,114 January 2032 (or earlier)d
(Orexigen) release tablet
More. . .

(Manufacturer)
Xartemis XR Oxycodone/acetaminophen Actavis May 2032 (or earlier)d,172

(Mallinckrodt) extended-release tablet
Zubsolv Buprenorphine/Naloxone Actavish,84 September 2032 (or earlier)d
(Orexo) sublingual tablet
Alocril Nedocromil ophthalmic Akorn Uncertaing
(Allergan)
Avandamet Rosiglitazone/Metformin Teva Uncertain27 (brand discontinued)
(SB Pharmco)
Avandaryl Rosiglitazone/Glimepiride Teva Uncertain27 (brand discontinued)
(SB Pharmco)
Avandia Rosiglitazone Mylan, Roxane, Sandoz, Teva, Hikma Uncertain27
(SB Pharmco)
Axiron Testosterone transdermal solution Actavis, Amneal,h,112 Lupin,h,112 Perrigo Uncertain (patents invalidated;
(Eli Lilly) generic could launch during appeal
process)112
Differin Adapalene topical solution 0.1% Call (Rochester) Uncertaing (brand discontinued)
(Galderma)
Exelon Rivastigmine oral solution (brand Ranbaxy Uncertaing (brand discontinued)
(Novartis) discontinued)
Kaletra Lopinavir/Ritonavir Tablet: Aurobindo, Cipla, Hetero, Matrix, Uncertain9,36,137
(Abbott) Macleods, Mylan
Oral solution: Cipla
Norvir Ritonavir 100 mg tablet Aurobindo, Cipla, Mylan, Hetero,h,73 Roxane Uncertain9,137
(Abbvie)
Oxytrol Oxybutynin transdermal patch Teva Uncertain37
(Actavis)
Prandimet Repaglinide/metformin tablet Lupin Uncertaing
(Novo Nordisk)
ProAir HFA Albuterol Perrigof,34 Uncertain34
(Teva)
Relpax Eletriptan Ajanta, Apotex, Mylan, Teva Uncertain24
(Pfizer)
More. . .

(Manufacturer)
Renagel Sevelamer hydrochloride (oral Impaxf,15 Uncertain (brand discontinued)

(Genzyme) suspension)(brand not available)
Renvela Sevelamer carbonate (oral Impaxf,15 Uncertaing
(Genzyme) suspension)
Rezira Hydrocodone/pseudoephedrine Coastal, Tris Pharma, Perrigo (Paddock) Uncertaing
(Hawthorn) oral solution
Safyral and Beyaz Drospirenone/Ethinyl Actavis Uncertain (perhaps before April
(Bayer) estradiol/Levomefolate calcium 2020)132,140
Sarafem Fluoxetine tablet Teva Uncertaing (brand discontinued)
(April)
Selzentry Maraviroc Hetero, Sandoz Uncertaing
(Pfizer)
Welchol Colesevelam tablet and oral Impax,f,22 Actavis,h,71 Glenmarkf,59 Uncertain22,59
(Daiichi Sankyo) suspension
a. This list is not all-inclusive.
b. Current through December 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.
c. Generic availability is subject to change as a result of litigations and patent exclusivities.
d. Patent challenged; availability may be sooner than patent expiration date.
e. Generic manufacturer has settled patent litigation with the brand manufacturer. Generic availability may be sooner than patent expiration date.
f. Generic manufacturer has not received approval or tentative approval from the FDA, but has settled patent litigation with the brand manufacturer. Generic
availability may be sooner than patent expiration date.
g. Patents have expired; however, generics are not yet available.
h. Generic manufacturer has not received approval or tentative approval from the FDA, but has filed patent challenge.
i. 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. . .
Project Leader in preparation of this clinical 11. United States District Court for the District of
resource (330146): Melanie Cupp, Pharm.D., Delaware. Novartis Pharmaceuticals Corporation,
Novartis Corporation, Novartis AG, and Novartis
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http://www.investors.com/news/technology/jazz- /30/wkr0006.pdf. (Accessed December 18, 2016).
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concerning Lialda. March 29, 2016. patents-found-valid-and-infringed-in-fanapt-anda-
https://www.shire.com/newsroom/2016/march/shire- litigation-300318458.html. (Accessed December 21,
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(Accessed December 19, 2016). 158. Food and Drug Administration. ANDA approval
letter. Actavis generic Diclegis. August 19, 2016.
More. . .
http://www.accessdata.fda.gov/drugsatfda_docs/appl 169. Wickham A. Reckitt sues to block Pars generic

etter/2016/205811Orig1s000ltr.pdf. (Accessed Suboxone. August 21, 2013.
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biosimiilar version of Amgens Enbrel. August 30, December 23, 2016).
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Cite this document as follows: Clinical Resource, Anticipated Availability of First-Time Generics. Pharmacists
Letter/Prescribers Letter. January 2017.
More. . .
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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 80 mg QD
Candesartan (Atacand) 4 mg QDa 8 mg QD or 16 mg QD or 16 mg QD or ---

divided BID divided BIDb divided BIDb to
32 mg QD or
divided BID
Eprosartan (Teveten) 400 mg QD 600 mg QDL 800 mg QD or 800 mg QD or ---

divided BIDd divided BIDd
Irbesartan (Avapro) 75 mg QDc 150 mg QD 300 mg QD 300 mg QD ---
Losartan (Cozaar) 25 mg QDe 50 mg QD or 100 mg QD or --- ---

divided BIDn divided BIDn
Olmesartan (Benicar) 10 mg QD 20 mg QDf 20 mg QDf to 40 mg QD ---
40 mg QD
Telmisartan (Micardis) 20 mg QD 40 mg QDg 40 mg QDg to 80 mg QD ---
80 mg QD
Valsartan (Diovan) 40 mg QD or 80 mg QDj or 160 mg QDj 320 mg QDk,m ---
20 mg BIDh 40 mg BIDi,m
More. . .
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #250801: Page 2 of 3)
a. Starting dose for heart failure.3

b. Consider lower starting dose for moderate hepatic impairment or volume-depleted patients.3
c. Starting dose for volume/sodium-depleted patients.6,17
d. Maximum dose is 600 mg QD in moderate or severe renal impairment.5
e. Starting dose for volume/sodium-depleted patients or patients with (or with a history of) hepatic impairment.7
f. Consider lower starting dose for volume-depleted patients.8
g. Use lower starting dose for hepatic impairment or volume/sodium-depleted patients.9
h. Starting dose post-MI.10
i. Starting dose for heart failure.10
j. Recommended initial dose for hypertension monotherapy in patients who are not volume-depleted. Dose cautiously in hepatic or severe renal
impairment.10
k. Divide BID for post-MI and heart failure indications.10
L. Recommended initial dose for monotherapy in patients who are not volume-depleted.5
m. Dose cautiously in hepatic or severe renal impairment.10
n. 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
organizations. Information and Internet links in this article were current as of the date of publication.
More. . .
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #250801: Page 3 of 3)
Project Leader in preparation of this Detail- 14. Sasaki T, Noda Y, Yasuoka Y, et al. Comparison of
Document: Melanie Cupp, Pharm.D., BCPS the effects of telmisartan and olmesartan on home
blood pressure, glucose, and lipid profiles in patients
with hypertension, chronic heart failure, and
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06877. January 2012. %20Antagonists,%20Drug%20Class%20Review.pdf.
10. Product information for Diovan. Novartis (Accessed February 13, 2012).
Pharmaceuticals Corporation. East Hanover, NJ 21. Smith DH. Comparison of angiotensin II type 1
07936. January 2012. receptor antagonists in the treatment of essential
11. Asmar R. Targeting effective blood pressure control hypertension. Drugs 2008;68:1207-25.
with angiotensin receptor blockers. Int J Clin Pract 22. Giles TD, Oparil S, Silfani TN, et al. Comparison of
2006;60:315-320. increasing doses of olmesartan medoxomil, losartan
12. Elliott WJ, Calhoun DA, DeLucca PT, et al. Losartan potassium, and valsartan in patients with essential
versus valsartan in the treatment of patients with mild hypertension. J Clin Hypertension 2007;9:187-95.
to moderate essential hypertension: data from a 23. Smith DH, Dubiel R, Jones M. Use of 24-hour,
multicenter, randomized, double-blind, 12-week trial. ambulatory blood pressure monitoring to assess
Clin Ther 2001;23:1166-79. antihypertensive efficacy: a comparison of
13. Nakayama S, Watada Hm Mita T, et al. Comparison olmesartan medoxomil, losartan potassium,
of effects of olmesartan and telmisartan on blood valsartan, and irbesartan. Am J Cardiovasc Drugs
pressure and metabolic parameters in Japanese 2005;5:41-50.
early-stage type-2 diabetes with hypertension.
Hypertens Res 2008;31:7-13.
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.
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PHARMACISTS LETTER / PRESCRIBERS LETTER
November 2016 ~ Resource #321152
Comparison of Angiotensin Receptor Blockers

--Information in chart is based on U.S. product labeling unless otherwise denoted.--
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 Dose for FDA- Usual or Target Clinical Benefit (Based on Level How Supplied/Wholesale Average
approved Indications in Maintenance Dose A evidence in adults) Cost of 30-day supply (generic, if
Adults (Adults) available)
Azilsartan HTN: 80 mg once daily.. 80 mg once daily 40, 80 mg
(Edarbi) Starting dose for $170.77 (80 mg once daily)
volume/sodium-depleted
patients is 40 mg once daily. With chlorthalidone (Edarbyclor; not
for volume/sodium-depleted patients):
40/12.5, 40/25
Candesartan Correct volume/sodium HTN: CHF: reduces risk of CV death or 4, 8, 16, 32 mg

(Atacand, depletion before starting. 8-32 mg daily in one CHF hospitalization
generics) or two divided doses $107.39 (32 mg once daily)
HTN: 16 mg once daily Diabetic retinopathy: reduces
(8 mg once daily for CHF: 32 mg once incidence (type 1 DM) and With HCT (Atacand HCT; indicated
moderate hepatic impairment) daily improves mild to moderate for HTN only; not for initial therapy;
retinopathy (type 2 DM)1,2 not for volume/sodium-depleted
CHF: 4 mg once daily patients; no information on use in
(Consider lower starting dose patients with CrCl <30 mL/min):
for moderate hepatic 16/12.5, 32/12.5, 32/25 mg
impairment.)
Eprosartan HTN: 600 mg once daily 400-800 mg daily in 600 mg

(Teveten one or two divided
brand not doses $342.59 (Average Wholesale Price)
available) 600 mg once daily
Max dose 600 mg in
moderate or severe
renal impairment.
More. . .
Irbesartan HTN: 150 mg once daily HTN: 150-300 mg Nephropathy (type 2 DM): 75, 150, 300 mg
(Avapro, once daily reduces rate of progression as
generics) Nephropathy (type 2 DM, measured by doubling of serum <$10 (300 mg once daily)
elevated serum creatinine, Nephropathy (type 2 creatinine or need for renal
and proteinuria): 75 mg once DM): 300 mg once replacement (e.g., dialysis) With HCT (Avalide; indicated for
daily daily HTN only; not for volume-depleted
patients; not recommended if
Volume/sodium-depleted CrCl <30 mL/min):
patients: 75 mg once daily. 150/12.5, 300/12.5
Losartan Correct volume/sodium HTN: HTN with LVH: reduces stroke 25, 50, 100 mg
(Cozaar, depletion before starting. 50-100 mg once risk (may not benefit African
generics) Starting dose for patients with daily Americans) <$5 (100 mg once daily)
possible intravascular volume
depletion or a history of HTN/LVH: With HCT (Hyzaar; indicated for
hepatic impairment is 25 mg 50-100 mg once Nephropathy (type 2 DM, elevated HTN and HTN with LVH only; not
once daily. daily (plus HCT if creatinine, and proteinuria): recommended in hepatic impairment;
needed) reduces rate of progression as not for volume-depleted patients; no
HTN with or without LVH: measured by doubling of serum information on use in patients with
50 mg once daily Nephropathy (type 2 creatinine or need for renal CrCl <30 mL/min):
DM): 50-100 mg replacement (e.g., dialysis) 50/12.5, 100/12.5, 100/25 mg
Nephropathy (type 2 DM,
once daily
elevated serum creatinine,
CHF: Reduces risk of CV death or
and proteinuria) plus HTN:
CHF: 150 mg once CHF hospitalization;3 mortality
50 mg once daily
daily3 (Off-label) similar to captopril4
CHF:
12.5 mg once daily (not
currently taking an ARB) or
25 mg once daily (switching
from another ARB)3
(Off-label use)
More. . .
Olmesartan HTN: 20 mg once daily. HTN: 20-40 mg None 5, 20, 40 mg
(Benicar) once daily
$242.70 (40 mg once daily)
Correct volume/sodium
depletion before starting. With HCT (Benicar HCT; not for
Consider a lower starting initial therapy; not for volume/
dose for patients with sodium-depleted patients; no
possible intravascular volume information on use in patients with
depletion. CrCl <30 mL/min): 20/12.5, 40/12.5,
40/25 mg
With amlodipine (Azor; not for initial
therapy in hepatic impairment): 5/20,
10/20, 5/40, 10/40 mg
With HCT and amlodipine
(Tribenzor; not for initial therapy;
avoid if CrCl <30 mL/min):
20/5/12.5, 40/5/12.5, 40/5/25,
40/10/12.5, 40/10/25 mg
Telmisartan Use lower starting dose for HTN: 40-80 mg High CV risk: reduces risk of CV 20, 40, 80 mg
(Micardis, hepatic impairment or once daily events (MI, stroke, death)
generics) volume/sodium-depleted $79.02 (80 mg once daily)
patients.
Hemodialysis patients with CHF: With HCT (Micardis HCT; indicated
CV risk reduction:
added to ACEI, reduces all-cause for HTN only; not for initial therapy;
HTN: 40 mg once daily 80 mg once daily
and CV mortality, and heart failure not for volume-depleted patients; not
hospitalization5 recommended if CrCl <30 mL/min):
CV risk reduction (in patients
40/12.5, 80/12.5, 80/25 mg
unable to take ACE
inhibitors):
With amlodipine (Twynsta; not for
80 mg once daily
initial therapy in patients >75 years of
age or hepatically impaired)
More. . .
Valsartan HTN: 80-160 mg once daily HTN: 80-320 mg CHF: reduces CHF hospitalization 40, 80, 160, 320 mg
(Diovan, once daily
generics) CHF (Class II to IV): 40 mg Post-MI with left ventricular $12.66 (320 mg once daily)
twice daily CHF: 40-160 mg dysfunction/failure: reduces CV
twice daily (target mortality With HCT (Diovan HCT; indicated
Post-MI with left ventricular 160 mg twice daily) for HTN only; not for volume-
dysfunction/failure: 20 mg HTN with high CV risk: reduces depleted patients: 80/12.5, 160/12.5,
twice daily Post-MI: 20-160 mg CV morbidity/mortality about as 160/25, 320/12.5, 320/25 mg
twice daily (target well as amlodipine6
No data in patients with 160 mg twice daily) With amlodipine (Exforge; indicated
CrCl <30 mL/min or severe for HTN only; not for volume-
hepatic impairment. depleted patients; not for initial
therapy in elderly or hepatically
impaired patients): 5/160, 10/160,
5/320, 10/320 mg
With amlodipine and HCT (Exforge

HCT; indicated for HTN only; not for
initial therapy; not for volume-
depleted patients
5/160/12.5, 10/160/12.5, 5/160/25,
10/160/25, 10/320/25 mg
U.S. product information used in preparation of this chart: Edarbi (March 2016), Edarbyclor (March 2016), Atacand (July 2016), Atacand HCT (July
2016), eprosartan (Mylan, November 2014), Avapro (July 2016), Avalide (July 2016), Cozaar (December 2015), Hyzaar (December 2015), Benicar
(May 2016), Benicar HCT (February 2016), Azor (May 2016), Tribenzor (May 2016), Micardis (December 2014), Micardis HCT (January 2016),
Twynsta (January 2016), Diovan (September 2016), Exforge (August 2015), Exforge HCT (July 2015).
Users of this resource are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
organizations. Information and internet links in this article were current as of the date of publication.
More. . .
Levels of Evidence randomised placebo-controlled trial. Lancet

In accordance with the trend towards Evidence-Based 2008;372:1385-93.
2. Chaturvedi N, Porta M, Klein R, et al. Effect of
Medicine, we are citing the LEVEL OF EVIDENCE
candesartan on prevention (DIRECT-Prevent 1) and
for the statements we publish. progression (DIRECT-Protect 1) of retinopathy in
Level Definition type 1 diabetes: randomised, placebo-controlled
A High-quality randomized controlled trial (RCT) trials. Lancet 2008;372:1394-402.
High-quality meta-analysis (quantitative 3. Konstam MA, Neaton JD, Dickstein K, et al. Effects
systematic review) of high-dose versus low-dose losartan on clinical
B Nonrandomized clinical trial outcomes in patients with heart failure (HEAAL
Nonquantitative systematic review study): a randomised, double-blind trial. Lancet
Lower quality RCT 2009;374:1840-8.
Clinical cohort study 4. Pitt B, Poole-Wilson PA, Segal R, et al. Effect of
Case-control study losartan compared with captopril on mortality in
Historical control patients with symptomatic heart failure: randomized
Epidemiologic study trialthe Losartan Heart Failure Survival Study
C Consensus ELITE II. Lancet 2000;355:1582-7.
Expert opinion 5. Cice G, Di Benedetto A, Dlsa S, et al. Effects of
D Anecdotal evidence telmisartan added to angiotensin-converting enzyme
In vitro or animal study inhibitors on mortality and morbidity in hemodialysis
Adapted from Siwek J, et al. How to write an evidence-based clinical patients with chronic heart failure a double-blind,
review article. Am Fam Physician 2002;65:251-8. placebo-controlled trial. J Am Coll Cardiol
2010;56:1701-8.
6. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in
Project Leader in preparation of this clinical hypertensive patients at high cardiovascular risk
resource (321152): Melanie Cupp, Pharm.D., treated with regimens based on valsartan or
BCPS amlodipine: the VALUE randomised trial. Lancet
2004;363:2022-31.
References
1. 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
Cite this document as follows: Clinical Resource, Comparison of Angiotensin Receptor Blockers. Pharmacists
Letter/Prescribers Letter. November 2016.
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Evidence and Recommendations You Can Trust

Angiotensin Receptor Blocker (ARB) Antihypertensive Dose Comparison

Abbreviations: BID=twice daily; MI=myocardial infarction; QD=once daily

Candesartan (Atacand) 4 mg QDa 8 mg QD or 16 mg QD or 16 mg QD or ---

Eprosartan (Teveten) 400 mg QD 600 mg QDL 800 mg QD or 800 mg QD or ---

Losartan (Cozaar) 25 mg QDe 50 mg QD or 100 mg QD or --- ---

a. Starting dose for heart failure.3

Evidence and Advice You Can Trust

Comparison of Angiotensin Receptor Blockers

Candesartan Correct volume/sodium HTN: CHF: reduces risk of CV death or 4, 8, 16, 32 mg

Eprosartan HTN: 600 mg once daily 400-800 mg daily in 600 mg

With amlodipine and HCT (Exforge

Levels of Evidence randomised placebo-controlled trial. Lancet

Evidence and Recommendations You Can Trust

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