New & Projected Patent Expirations

Transcription

1 Asacol HD (Apil) Mesalamine delayed-release tablet 800 mg Zydus Generic now available Avage (Allergan) Tazarotene 0.1% cream Taro Generic now available Axiron (Eli Lilly) Testosterone transdermal solution Perrigo, Teva Generic now available Azilect (Teva) Rasagiline mesylate tablet Alvogen (Orchid), Teva (authorized generic) Generic now available Beyaz (Bayer) Drospirenone/Ethinyl estradiol/levomefolate calcium Teva (Rajani) Generic now available Busulfex (Otsuka) Busulfan injection American Regent (Luitpold), Sagent (Pharmascience) Generic now available Clolar (Genzyme) Clofarabine Fresenius Kabi (Abon) Generic now available Cordran (Aqua) Flurandrenolide 0.05% lotion Perrigo Generic now available Effient (Eli Lilly) Prasugrel Mylan, Prasco Labs (authorized generic) Generic now available Epiduo (Galderma) Adapalene 0.1%/Benzoyl peroxide 2.5% Teva Generic now available Lialda (Shire) Mesalamine delayed-release tablet 1.2 g Cadila (Zydus) Generic now available Minastrin 24 Fe (Warner Chilcott) Ethinyl estradiol/norethindrone acetate/ferrous fumarate Lupin (Mibelas) Generic now available Pataday (Alcon) Olopatadine 0.2% ophthalmic solution Teva Generic now available Prandimet (Novo Nordisk) Repaglinide/metformin tablet Lupin Generic now available Pristiq (Wyeth) Desvenlafaxine succinate extended-release tablet Lupin, Mylan, Teva (Actavis), West-Ward Generic now available Quartette (Teva) Levonorgestrel/Ethinyl estradiol Lupin (Fayosim) Generic now available Relpax (Pfizer) Eletriptan Ajanta, Teva Generic now available Renvela (Genzyme) Sevelamer carbonate (for oral suspension and tablet) Aurobindo Generic now available Sabril (Lundbeck) Vigabatrin for oral solution Par Generic now available Sarafem (Apil) Fluoxetine 10 mg tablet Torrent Generic now available Strattera (Lilly) Atomoxetine Glenmark, Teva Generic now available Tazorac (Allergan) Tazarotene 0.1% cream Taro Generic now available Transderm Scop (GlaxoSmithKline) Scopolamine patch Perrigo Generic now available Vigamox (Alcon) Moxifloxacin ophthalmic solution Apotex, Lupin Generic now available Virazole (Valeant) Ribavirin inhalation solution Zydus (Navinta) Generic now available Vytorin (Merck) Ezetimibe/Simvastatin Impax, Teva Generic now available Zetia (Merck) Ezetimibe Amneal, Apotex, Ohm, Par (Glenmark),Sandoz, Teva Generic now available Cancidas (Merck) Caspofungin Gland, Sandoz September 2017 Herceptin (Roche) Trastuzumab Mylan (biosimilar i ), Celltrion/Teva (biosimilar i ) 100 September Adcirca (Lilly) Tadalafil Aurobindo, Synthon November /7

2 Sustiva (Bristol-Myers Squibb) Viagra (Pfizer) Viread (Gilead) Copaxone (Teva) Efavirenz Sildenafil Tenofovir disoproxil fumarate tablet Glatiramer 40 mg/ml "Tablet: Aurobindo, Cipla, Emcure, Hetero, Macleods, Matrix, Micro Labs, Mylan, Par, Pharmacare, Strides, Teva Capsule: Aurobindo, Cipla, Micro Labs "Ajanta, Amneal, Apotex, Appco, Aurobindo, Dr. Reddy s, Hetero, Macleods, Mylan, Reyoung, Rubicon, Teva Aurobindo, Cipla, InvaGen, Lupin, Macleods, Matrix, Mylan, Pharmacare, Strides Arcolab, Teva December December 2017 (or earlier) 92 December Dr. Reddy s, h,94 Mylan, h,146 Momenta/Novartis, h,146 Sandoz, h,70 others 30 First half ,146 Treximet (Pozen) Sumatriptan/Naproxen Alphapharm, f,102 Dr. Reddy s, Mylan, Par, Teva f,102 February Factive (Cornerstone) Gemifloxacin tablet Orchid March Sensipar (Amgen) Cinacalcet tablet Aurobindo, Mylan, Teva March Enbrel (Amgen) Etanercept Sandoz (biosimilar i ) April 2018 or later 159 Lexiva (Vertex) Fosamprenavir tablet Lupin, Mylan, Ranbaxy f,130 June Remodulin (United Therapeutics) Treprostinil injection Sandoz June 2018 (or earlier) 126 Levitra (GlaxoSmithKline) Vardenafil tablet Macleods, Teva 3 rd quarter Acanya (Valeant) Benzoyl peroxide 2.5%/ Clindamycin phosphate 1.2% Teva July 2018 (or earlier) 87 Ampyra (Acorda) Aloxi (Eisai) Dalfampridine extended-release tablet Palonosetron injection Accord, Alkem, Allergan, f,119 Aurobindo, Mylan, Par, f Roxane, Sun, Teva Akorn, Aurobindo, Dr. Reddy s, Exela, Fresenius Kabi, Sandoz, Sagent, Teva July September 2018 (or earlier) 78 Cialis (Eli Lilly) Tadalafil Alembic, Aurobindo, Sun, Teva September Staxyn (Bayer) Vardenafil orally disintegrating tablet Alembic, Macleods, Par, Teva October ,96 Vesicare (Astellas) Solifenacin succinate Ajanta, Glenmark, Teva October Finacea (Bayer) Azelaic acid gel Glenmark November 2018 Fortesta (Endo) Testosterone gel Teva November 2018 Lyrica (Pfizer) Pregabalin "Capsule: Alembic, Alkem, Apotex, Aurobindo, Lupin, Macleods, Mylan, Sandoz, Teva, Wockhardt Oral solution: Apotex, Lupin, Novel December Rapaflo (Allergan) Silodosin Lupin, Sandoz Before December 2018 e,19 Latuda (Sunovion) Lurasidone Accord, Amneal, Aurobindo, Emcure, InvaGen, Lupin, MSN, Par, Sun, Teva, Zydus January ,135 Zyclara (Medicis) Imiquimod cream Actavis f,17 January 2019 (or earlier) 17 Gilenya (Novartis) Fingolimod Accord, Alkem, Aurobindo, Biocon, Glenmark, MSN, Par, Strides, Teva, Torrent, f,173 Zydus, February /7

3 Ranexa (Gilead) Ranolazine Teva February Solodyn (Medicis) Minocycline extended-release tablet 55 mg, 65 mg, 80 mg, 105 mg, 115 mg Apotex, h,117 Alkem, Aurobindo, Mylan, Sandoz, Sidmak, Sun February AzaSite (InSite Vision) Azithromycin 1% ophthalmic solution Mylan, f,13 Sandoz March 2019 Emend (Merck) Fosaprepitant injection Fresenius Kabi, Sagent, Sandoz March ,90 Faslodex (AstraZeneca) Fulvestrant Sandoz f,144 March 2019 (or earlier) 144 Exjade (Novartis) Deferasirox tablets for oral suspension Actavis Elizabeth, Mylan h,11 Before April 2019 e,43 Canasa (Aptalis) Mesalamine rectal suppository 1 g Mylan, Renaissance, Sandoz, Zydus June 2019 (or earlier) 133 Sporanox (Janssen) Itraconazole solution Fera h,45 June 2019 (or earlier d ) Uloric (Takeda) Febuxostat Alembic, Dr. Reddy s, h,97 Hetero, h,97 Lupin, Macleods, Mylan, Ranbaxy, h,97 Roxane, Sun h,97 June ,47 Ziagen (Viiv) Abacavir oral solution Camber (Hetero) August 2019 (or earlier d ) 21 Edluar (Orexo) Zolpidem sublingual tablet Mylan, Par September ,155 Zubsolv (Orexo) Buprenorphine/Naloxone sublingual tablet Actavis f,84 September Treanda (Teva) Bendamustine 25 mg/vial and 100 mg/vial Accord, Apotex, Breckinridge, Glenmark, Hospira, InnoPharma, Sagent, f,107 Wockhardt November 2019 (or earlier) 111 Daliresp (AstraZeneca) Roflumilast Apotex, h,72 Hetero, Mylan, Strides Pharma, others 72 January 2020 (or earlier d ) 72,156 Namenda XR (Forest) Memantine extended-release capsule Amneal, Anchen, Apotex, Lupin, Macleods, Mylan, Sun, Teva, f,58 Wockhardt, h,118 Zydus January Silenor (Somaxon) Doxepin tablet Actavis, Mylan, Par, Zydus January 2020 (or earlier) 39 Delzicol (Warner Chilcott) Mesalamine delayed-release capsule Cadila, f,139 Mylan, h,115 Zydus f,109 March 2020 (or earlier) 109,139 Safyral (Bayer) Drospirenone/Ethinyl estradiol/levomefolate calcium Teva April 2020 (or earlier ) Chantix (Pfizer) Varenicline Apotex, Mylan, Teva May 2020 (or earlier d ) 49 Dexilant (Takeda) Dexlansoprazole Impax, f,104 Par, TWi f,93 June Avelox (Bayer) Moxifloxacin 0.8% IV solution Mylan July 2020 (earlier d ) 21 Desonate (Bayer) Desonide 0.05% gel Teresina August 2020 (or earlier d ) 21 Kuvan (BioMarin) Sapropterin Dr. Reddy s, f,91 Par October 2020 (or earlier) 161 Absorica (Ranbaxy) Isotretinoin Actavis f,88 December 2020 (or earlier) 88 Ofirmev (Mallinckrodt) Acetaminophen injection Custopharm (Perrigo), Sandoz December 2020 (or earlier) 31 Sutent (Pfizer) Sunitinib Mylan February 2021 Jevtana (Sanofi Aventis) Cabazitaxel Accord, Actavis, Apotex, BPI, h,122 Breckenridge, h,54 Dr. Reddy s, h,121 Fresenius Kabi, h,170 Sandoz March 2021 (or earlier d ) 151 Tarceva (OSI) Erlotinib Apotex May 2021 (or earlier d ) 76 3/7

4 Diclegis (Duchesnay) Doxylamine/Pyridoxine Actavis Before June 2021 e,158 Perforomist (Mylan) Formoterol inhalation solution Teva June 2021 Selzentry (Pfizer) Maraviroc Hetero, Sandoz August 2021 (or earlier d ) 21 Bystolic (Forest) Nebivolol Actavis, f,67 Alkem, f,67 Amerigen, f,67 Glenmark, f,63,67 Hetero, f,67 Indchemie, f,67 Torrent f,67 September 2021 (or earlier) 67 Atripla (Gilead) Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Aurobindo, Cipla, Hetero, Macleods, Matrix, Teva Before September 2021 e,10,68 Emtriva (Gilead) Emtricitabine capsule Aurobindo, Cipla, Matrix September 2021 (or earlier d ) 4 Truvada (Gilead) Emtricitabine/Tenofovir disoproxil fumarate tablet Aurobindo, Cipla, Hetero, Lupin, f,25 Matrix, Mylan, h,25 Strides Arcolab, Teva Before September 2021 e,112 Brovana (Sunovion) Arformoterol Cipla, Teva November 2021 (or earlier d ) 21 Pradaxa (Boehringer Ingelheim) Dabigatran Alembic, Glenmark, Hetero, h,44 Teva December 2021(or earlier d ) 44 Velcade (Millennium) Bortezomib Accord, Apotex, Fresenius Kabi, Hospira, Pharmascience, Teva Revlimid (Celgene) Lenalidomide Allergan f,23 March Vimpat (UCB) Lacosamide "Tablet: Accord, Alembic, Amneal, Aurobindo, Glenmark, MSN, Mylan, Sun, Teva Oral solution: Amneal, Apotex, Glenmark January 2022 (or earlier d ) 125 March Zipsor (Depomed) Diclofenac potassium liquid-filled capsule Actavis, f,95 Bionpharma March 2022 (or earlier) 95 Alimta (Lilly) Pemetrexed Accord, Apotex, APP, Emcure, h,69 Heritage, h,69 Hospira, Qilu, Sandoz, h,56 Teva May 2022 (or earlier d ) Banzel (Eisai) Rufinamide Glenmark, Hetero, h,80 Lupin, f,145 Mylan, Roxane, h,80 West-Ward May 2022 (or earlier) 48 Vimovo (Horizon) Naproxen/Esomeprazole magnesium delayed-release tablet Actavis, h,77 Dr. Reddy s, Lupin, f,77 Mylanh, 77 May 2022 (or earlier d ) 77 Viibryd (Forest) Vilazodone Accord, Alembic, Ivagen, h,2 Teva June 2022 (or earlier d ) Janumet (Merck) Sitagliptin/Metformin Apotex, Sandoz, Teva, Zydus July 2022 (or earlier d ) 21,124 Janumet XR (Merck) Sitagliptin/Metformin extended- release tablet Anchen, Teva July 2022 (or earlier d ) 21,124 Januvia (Merck) Sitagliptin Apotex, Mylan, Sandoz, Sun, Teva July 2022 (or earlier d ) 21,124 Toviaz (Pfizer) Fesoterodine extended-release tablet Accord, f,108,141 Alembic, Amerigen, Amneal, Aurobindo, Cadila, f,108,141 Dr. Reddy s, Impax, f,108,141 Mylan, h,141,147 Lupin, Sandoz, Sun, Teva, Wockhardt, h,82 Zydus f,108,141 July 2022 (or earlier d ) 82,141,147 Folotyn (Spectrum) Pralatrexate Teva November Rayos (Horizon) Prednisone delayed-release tablet Teva December 2022 (or earlier) 36 Humira (AbbVie) Adalimumab Amgen (biosimilar i ), Boehringer Ingelheim (biosimilar i ) 26 January Vyvanse (Shire) Lisdexamfetamine Actavis, Amneal, Mylan, Roxane, Sandoz February Epiduo Forte (Galderma) Adapalene 0.3%/Benzoyl peroxide 2.5% Taro March 2023 (or earlier d ) 21 4/7

5 Suprep (Braintree) Magnesium sulfate anhydrous, potassium sulfate, sodium sulfate Novel, Paddock (Perrigo), Breckenridge f,174 March Edurant (Janssen) Rilpivirine Strides Arcolab April Livalo (Kowa) Pitavastatin Aurobindo, Lupin, Mylan, h,138 Orient, Sawai, Zydus f,136 May 2023 (or earlier) 136 Gralise (Depomed) Gabapentin Incepta, f,98 Zydus, f,98 Teva January 2024 (or earlier) 62,98 Bepreve (Bausch and Lomb) Bepotastine 1.5% ophthalmic solution Sandoz September 2024 (or earlier d ) 21 Fentora (Cephalon [Teva]) Fentanyl citrate buccal tablet Impax, f,57 Mylan, f,89 Sandoz, f,106 Before December 2024 e,57 Namzaric (Forest) Donepezil/Memantine Amneal January Nucynta (Depomed) Tapentadol tablet Tablet: Alkem, Roxane, Teva Oral solution: Teva June Nucynta ER (Depomed) Tapentadol extended-release tablet Teva, West-ward June Qsymia (Vivus) Phentermine/Topiramate extended-release capsule Dr. Reddy s, f Teva h,41 June 2025 (or earlier e ) 46 Xyrem (Jazz) Sodium oxybate Amneal, Ohm, Par, h,7 Ranbaxy, f,143 Roxane (West-Ward), Sun, f,153 Wockhardt f,143 December Sprycel (Bristol-Myers Squibb) Dasatinib Apotex Before March 2026 e,152 Afinitor (Novartis) Everolimus Breckenridge, h,148 Par, West-Ward May 2026 (or earlier d ) 148 Natazia (Bayer) Dienogest/estradiol valerate Lupin, h,61 Teva May 2026 (or earlier d ) 61,165 Aplenzin (Valeant) Bupropion hydrobromide extended-release tablet Teva, Paddock, h,105 Par f,83 Before June 2026 e,38,83 Cambia (Depomed) Diclofenac potassium oral solution 50 mg Par Before June 2026 e,150 Nuedexta (Avanir) Dextromethorphan/Quinidine Impax, f,116 Par, Sandoz, f,103 Wockhardt f,85 July 2026 (or earlier) 85,103 Dymista (Meda) Azelastine and fluticasone nasal spray Apotex August 2026(or earlier d ) 21 AndroGel 1.62% (AbbVie) Testosterone Perrigo, Teva October 2026 (or earlier) e,166 Saphris (Forest) Asenapine Alembic October 2026 (or earlier d ) 21 Prezista (Janssen) Darunavir tablet Cipla, Hetero, Lupin, Mylan, Teva Before February Aveed (Endo) Testosterone undecanoate Paddock f,176 March Tradjenta (Boehringer Ingelheim) Linagliptin Aurobindo May 2027 (or earlier d ) 120 Lumigan (Allergan) Bimatoprost ophthalmic solution 0.01% Actavis, f,123 Apotex, Hi-Tech, f,123 Lupin, f,123 Sandoz June Travatan Z (Alcon) Travoprost 0.004% ophthalmic solution Apotex, Mylan, Par Before September Fanapt (Vanda) Iloperidone Inventia, Roxane f,157 November Nexavar (Bayer) Sorafenib Mylan December 2027 (or earlier d ) 21 Oracea (Galderma) Doxycycline 40 mg capsule Amneal, Lupin, Mylan December /7

6 Promacta (Novartis) Eltrombopag Hetero February 2028 (or earlier d ) 21 Prepopik (Ferring) Citric acid, magnesium oxide, sodium picosulfate Par October Onglyza (Bristol-Myers Squibb) Saxagliptin Amneal, Aurobindo, Glenmark, Par, Teva h,99 November 2028 (or earlier d ) Pennsaid (Horizon) Diclofenac sodium 2% solution Amneal, Lupin, Perrigo (Paddock), Taro, Teva January 2029 (or earlier) 66 Colcrys (Takeda) Colchicine Hikma, h,42 Par, Teva Lo Loestrin Fe (Actavis) Ethinyl estradiol/norethindrone acetate/ferrous fumarate Tygacil (Wyeth) Tigecycline injection Fresenius Kabi, Sandoz February 2029 (or earlier e ) 64 (authorized generic available) Glenmark, Jai (Mylan) February 2029 (or earlier e ) 32 February (authorized generic available) Isentress (Merck) Raltegravir tablet Hetero March 2029 (or earlier d ) 21 Brisdelle (Noven) Paroxetine mesylate 7.5 mg capsule Prinston, Teva April 2029 (or earlier d ) 9 Moxeza (Alcon) Moxifloxacin ophthalmic solution Lupin, Teva May 2029 (or earlier e ) 6 Onexton (Dow) Savella (Forest) Benzoyl peroxide 3.75%/ Clindamycin phosphate 1.2% Milnacipran Actavis/Teva, h,28 Allergan, h,113 Perrigo, h,12 Taro Amneal, Apotex, f,14 First Time US Generics, h,167 Glenmark, Hetero, h,168 Lupin, Mylan, Par, Ranbaxy, h,168 Sandoz h,52 August 2029 (or earlier) d September 2029 (or earlier) 127 (may be authorized generic) 127 Tykerb (Novartis) Lapatinib Natco September 2029 (or earlier d ) 21 Suboxone (Reckitt Benckiser) Buprenorphine/Naloxone sublingual film Par, h,169 Teva, h,86 March 2030 (or earlier d ) Relistor (Salix) Methylnaltrexone 12 mg/0.6 ml subcutaneous injection Mylan December 2030 (or earlier d ) 21 Giazo (Valeant) Balsalazide 1.1 g tablet Apotex, h,129 Lupin, Mylan, Par June 2031 (or earlier e ) 75 Mirvaso (Galderma) Brimonidine tartrate gel Perrigo June 2031 (or earlier d ) 53 Multaq (Sanofi-Aventis) Dronedarone Amneal, Alkem, Glenmark, Unimark, h,134 Teva June 2031 (or earlier d ) 134 Contrave (Orexigen) Bupropion/Naltrexone sustained release tablet Actavis h,114 January 2032 (or earlier d ) 114 Xartemis XR (Mallinckrodt) Oxycodone/acetaminophen extended-release tablet Teva May 2032 (or earlier, but not before June 2020 d ) 172 Zohydro (Pernix) Hydrocodone extended-release capsule Alvogen, Teva September Acticlate (Aqua) Doxycycline hyclate tablet 75 mg, 150 mg Mayne Uncertain g Advair Diskus (GlaxoSmithKline) Fluticasone/salmeterol None (Mylan and West-Ward have filed for approval) 73,101 Uncertain g,142 Alocril (Allergan) Nedocromil ophthalmic Akorn Uncertain g Avandamet (SB Pharmco) Rosiglitazone/Metformin Teva Avandaryl (SB Pharmco) Rosiglitazone/Glimepiride Teva Uncertain 27 (brand Uncertain 27 (brand 6/7

7 Avandia (SB Pharmco) Rosiglitazone Mylan, Dr. Reddy s, Roxane, Sandoz, Teva, Hikma Uncertain 27 Differin (Galderma) Adapalene topical solution 0.1% Call (Rochester) Exelon (Novartis) Rivastigmine oral solution Ranbaxy (Sun) Kaletra (Abbott) Lopinavir/Ritonavir Tablet: Aurobindo, Cipla, Hetero, Matrix, Macleods, Mylan Oral solution: Cipla, Silarx Uncertain g (brand Uncertain g (brand Uncertain 137 Liptruzet (Merck) Atorvastatin/Ezetimibe Teva Uncertain g Norvir (Abbvie) Ritonavir 100 mg tablet Aurobindo, Cipla, Mylan, Hetero, West-Ward Oxytrol (Allergan) Oxybutynin transdermal patch Teva Uncertain 37 ProAir HFA (Teva) Albuterol Perrigo f,34 Uncertain 34 Renagel (Genzyme) Sevelamer hydrochloride (oral suspension)(brand not available) Impax f,15 Uncertain (sometime in 2017 or 2018) 137 Uncertain (brand Reyataz (Bristol-Myers Squibb) Atazanavir capsule Aurobindo, Emcure, Matrix, Pharmacare, Teva Uncertain 83 Rezira (Hawthorn) Hydrocodone/pseudoephedrine oral solution Mayne, Tris Pharma, Perrigo (Paddock) Uncertain g Topicort (Taro) Desoximetasone 0.25% spray Perrigo Uncertain g Vituz (Cypress) Hydrocodone bitartrate/ chlorpheniramine maleate Acella, Tris Uncertain g Welchol (Daiichi Sankyo) Colesevelam tablet and oral suspension Impax, f,22 Actavis, h,71 Glenmark, f,59 Uncertain 22,59 7/7