ANDA Approvals

Spring 2018

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/8/2018 Xenazine Tetrabenazine Valeant Pharms Dr Reddys
1/9/2018 Tamiflu Oseltamivir Phosphate Roche Lupin
1/12/2018 K-Tab Potassium Chloride AbbVie Paddock
1/16/2018 Ultiva Remifentanil HCl Mylan Fresenius Kabi
1/17/2018 Dilaudid Hydromorphone HCl Rhodes Pharms Ascent Pharms
1/19/2018 Taxotere Docetaxel Accord Healthcare / Sanofi Aventis Amneal
1/19/2018 Xyzal Allergy 24HR (OTC) Levocetirizine Dihydrochloride (OTC) Sanofi-Aventis Dr Reddys
1/23/2018 Epiduo Adapalene / Benzoyl Peroxide Galderma Labs Perrigo
1/23/2018 Bumex Bumetanide Validus Pharms Upsher-Smith Labs
1/23/2018 Celebrex Celecoxib GD Searle CSPC Ouyi Pharm
1/24/2018 Epiduo Adapalene / Benzoyl Peroxide Galderma Labs Taro
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Cipla 
1/26/2018 Truvada Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Aurobindo
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Hetero Labs
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Aurobindo
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Strides
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead MacLeods
1/26/2018 Argatroban Argatroban Novartis Amneal
1/26/2018 Feldene Piroxicam Pfizer Strides
1/29/2018 Kapvay Clonidine HCl Concordia Pharms Jubilant Generics
2/1/2018 Concerta Methylphenidate HCl Janssen Amneal
2/1/2018 Niaspan Niacin AbbVie Aurobindo
2/2/2018 Effient Prasugrel Eli Lilly Accord Healthcare
2/2/2018 Opana Oxymorphone HCl Endo Ascent Pharms
2/6/2018 Toprol-XL Metoprolol Succinate Aralez Pharms Novast Labs
2/7/2018 Syprine Trientine HCl Aton Watson
2/8/2018 Cleocin T Clindamycin Phosphate Pharmacia and Upjohn Glasshouse Pharms
2/9/2018 Tricor Fenofibrate AbbVie Amneal
2/9/2018 Namenda Memantine HCl Allergan Apotex
2/12/2018 Copaxone Glatopa Teva Sandoz
2/13/2018 Cardura Doxazosin Mesylate Pfizer Heritage Pharma
2/13/2018 Diprolene Betamethasone Dipropionate Merck Sharp Dohme Teligent Pharma
2/15/2018 Treximet Sumatriptan / Naproxen Sodium Pernix Ireland Aurobindo
2/16/2018 Adenocard Adenosine Astellas Gland Pharma
2/20/2018 Tamiflu Oseltamivir Phosphate Roche Lupin
2/21/2018 Feldene Piroxicam Pfizer Laboratorios Cinfa
2/22/2018 Zantac 150 (OTC) Ranitidine HCl (OTC) Sanofi Vivimed Global
2/23/2018 Strattera Atomoxetine HCl Eli Lilly Dr Reddys
2/23/2018 Lotronex Alosetron HCl Sebela Ireland Par
2/23/2018 Tamiflu Oseltamivir Phosphate Roche Hetero Labs
2/26/2018 Ritalin LA Methylphenidate HCl Novartis Mayne Pharma
2/26/2018 Suprane Desflurane Baxter Healthcare Shanghai Hengrui
2/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Laurus Labs
2/27/2018 Precedex Dexmedetomidine HCl Hospira Zydus
2/27/2018 Yaz Lo-Zumandimine Bayer Aurobindo
2/28/2018 Activella Estradiol / Norethindrone Acetate Amneal Accord Healthcare
3/2/2018 Bystolic Nebivolol HCl Allergan Torrent
3/2/2018 Viread Tenofovir Disoproxil Fumarate Gilead Qilu Tianhe
3/2/2018 Ritalin Methylphenidate HCl Novartis Bionpharma
3/5/2018 Eloxatin Oxaliplatin Sanofi Aventis / Teva Actavis
3/5/2018 Zantac 75 (OTC) Ranitidine HCl (OTC) Sanofi Vivimed Global
3/5/2018 Urocit-K Potassium Citrate Mission Pharma Teva
3/6/2018 Nuvigil Armodafinil Cephalon Aurobindo
3/6/2018 Gablofen Baclofen Piramal Mylan
3/7/2018 Integrilin Eptifibatide Schering Sagent
3/7/2018 Zovirax Acyclovir Mylan Yiling Pharm
3/8/2018 Sensipar Cinacalcet HCl Amgen Aurobindo
3/8/2018 Sensipar Cinacalcet HCl Amgen Cipla
3/9/2018 Zanaflex Tizanidine HCl Covis Pharma Zydus
3/12/2018 Sustiva Efavirenz Bristol-Myers Squibb Strides
3/13/2018 Sabril Vigabatrin Lundbeck Amneal
3/14/2018 Ziagen Abacavir Sulfate ViiV Healthcare Aurobindo
3/16/2018 Zegerid (OTC) Omeprazole / Sodium Bicarbonate (OTC) Bayer Zydus
3/16/2018 Solodyn Minocycline HCl Medicis Alkem Labs
3/16/2018 Naropin Ropivacaine HCl Fresenius Kabi Akorn
3/16/2018 Dacogen Decitabine Otsuka Sagent
3/16/2018 Topicort Desoximetasone Taro Lupin
3/16/2018 Glucophage XR Metformin HCl Bristol-Myers Squibb Granules
3/19/2018 Cyclophosphamide Cyclophosphamide West-Ward Pharms Amerigen Pharms
3/19/2018 Glucophage XR Metformin HCl Bristol-Myers Squibb Alignscience Pharma
3/20/2018 Renvela Sevelamer Carbonate Genzyme Sandoz
3/20/2018 Keppra Levetiracetam UCB Hainan Poly Pharm
3/20/2018 Ultravate Halobetasol Propionate Sun Pharm Inds Teligent Pharma
3/21/2018 Concerta Methylphenidate HCl Janssen Actavis
3/21/2018 Patanol Olopatadine HCl Novartis Micro Labs
3/21/2018 Loestrin 24 FE Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Apil Apotex
3/21/2018 Lioresal Baclofen Saol Theraps Res Mylan
3/22/2018 Concerta Methylphenidate HCl Janssen Actavis
3/23/2018 Aloxi Palonosetron HCl Helsinn Healthcare Teva
3/23/2018 Lialda Mesalamine Shire Actavis
3/23/2018 Toprol-XL Metoprolol Succinate Aralez Pharms Zydus
3/26/2018 Tikosyn Dofetilide Pfizer Sigmapharm Labs
3/26/2018 Clobex Clobetasol Propionate Galderma Labs Lupin
3/26/2018 Clobex Clobetasol Propionate Galderma Labs Taro
3/26/2018 Clobex Clobetasol Propionate Galderma Labs Glenmark
3/26/2018 Yasmin Zumandimine Bayer Aurobindo
3/28/2018 Advil Liqui-Gels (OTC) / Advil Migraine Liqui-Gels (OTC) Ibuprofen (OTC) Pfizer Strides
3/30/2018 Nimbex Cisatracurium Besylate AbbVie Hospira
3/30/2018 Nimbex Cisatracurium Besylate AbbVie Hospira
3/30/2018 Lipitor Atorvastatin Calcium Pfizer Accord Healthcare
3/30/2018 Dolophine Methadone HCl West-Ward Pharms Sun Pharm
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