ANDA Approvals

Spring 2019

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/2/2019 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Alembic Pharms
1/3/2019 Latuda Lurasidone HCl Sunovion Amneal
1/3/2019 Latuda Lurasidone HCl Sunovion Invagen Pharms
1/3/2019 Latuda Lurasidone HCl Sunovion Lupin
1/3/2019 Latuda Lurasidone HCl Sunovion Accord Hlthcare
1/3/2019 Aubagio Teriflunomide Sanofi Aventis Sandoz
1/3/2019 Dolophine Methadone HCl West-Ward Pharms Ascent Pharms
1/4/2019 Naproxen Sodium Naproxen Sodium (OTC) Bionpharma Catalent
1/4/2019 Latuda Lurasidone HCl Sunovion Sun Pharma
1/4/2019 Rythmol SR Propafenone HCl GlaxoSmithKline Sinotherapeutics
1/7/2018 Abilify Aripiprazole Otsuka Zydus
1/7/2018 Zytiga Abiraterone Acetate Janssen Amneal
1/7/2018 Picato Ingenol Mebutate Leo Labs Perrigo UK Finco
1/7/2018 Aubagio Teriflunomide Sanofi Aventis Accord Healthcare
1/8/2019 Exelon Rivastigmine Novartis Amneal
1/8/2019 CellCept Mycophenolate Mofetil Roche Concord Biotech
1/9/2019 Picato Ingenol Mebutate Leo Labs Perrigo
1/9/2019 Medrol Methylprednisolone Pharmacia and Upjohn RiconPharma
1/10/2019 Benicar Olmesartan Medoxomil Daiichi Sankyo Qilu Pharm
1/10/2019 Fluoxetine HCl Fluoxetine HCl Alvogen Sciegen
1/11/2019 Caduet Amlodipine Besylate / Atorvastatin Calcium Pfizer Zydus
1/11/2019 Betamethasone Dipropionate Betamethasone Dipropionate Fougera Zydus
1/11/2019 Zovirax Acyclovir Bausch & Lomb Torrent
1/11/2019 Femara Letrozole Novartis Eugia Pharma
1/14/2019 Viramune Nevirapine Boehringer Ingelheim MacLeods
1/14/2019 Microzide Hydrochlorothiazide Allergan Sales Sciegen
1/14/2019 Busulfex Busulfan Otsuka Nexus Pharms
1/14/2019 Lotronex Alosetron HCl Sebela Rising Pharms
1/14/2019 Sabril Vigabatrin Lundbeck Teva
1/15/2019 Relpax Eletriptan Hydrobromide Pfizer Aurobindo
1/15/2019 Plaquenil Hydroxychloroquine Sulfate Concordia Pharms Laurus Labs
1/16/2019 Diamox Acetazolamide Teva Xylopia
1/16/2019 Effient Prasugrel Eli Lilly and Co HEC Pharm
1/16/2019 Syprine Trientine HCl Aton Navinta
1/17/2019 Gleevec Imatinib Mesylate Novartis Shilpa Medicare
1/17/2019 Gleevec Imatinib Mesylate Novartis Wockhardt
1/18/2019 Precedex Dexmedetomidine HCl Hospira Cipla
1/18/2019 Prevacid Lansoprazole Takeda Alkem Labs
1/18/2019 Levo-T / Synthroid / Thyro-Tabs/ Unithroid Levothyroxine Sodium Cediprof / AbbVie / Lloyd / Stevens Lupin
1/18/2019 Cyclophosphamide Cyclophosphamide West-Ward Pharms Cipla
1/18/2019 Zovirax Acyclovir Bausch & Lomb Cipla
1/22/2019 Adderall XR Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate Shire Amerigen Pharms
1/22/2019 Klor-Con Potassium Chloride Upsher-Smith Labs PII
1/22/2019 Tikosyn Dofetilde Pfizer Aurobindo
1/22/2019 Retin-A Tretinoin Valeant  Taro Pharms
1/23/2019 Brilinta Ticagrelor AstraZeneca Amneal
1/23/2019 Brilinta Ticagrelor AstraZeneca Hisun Pharm Hangzhou
1/24/2019 Trusopt Dorzolamide HCl Merck FDC
1/24/2019 Suboxone Buprenorphine HCl / Naloxone HCl Indivior Alvogen Pine Brook
1/25/2019 Aleve PM Naproxen Sodium / Diphenhydramine Chloride Bayer Healthcare Actavis
1/25/2019 Integrilin Eptifibatide Schering Hainan Poly Pharm
1/25/2019 Bentyl Dicyclomine HCl Allergan Fresenius Kabi
1/25/2019 Depo-Provera Medroxyprogesterone  Acetate Pharmacia and Upjohn Cipla
1/25/2019 Retin-A Tretinoin Valeant Taro Pharms
1/25/2019 Fluoxetine Hydrochloride Fluoxetine Hydrochloride Alvogen Dr Reddy's Labs
1/25/2019 Zanaflex Tizanidine HCl Covis Pharma Alkem Labs
1/25/2019 Lialda Mesalamine Shire Sun Pharm
1/28/2019 Lactated Ringer's in Plastic Container Sodium Chloride / Sodium Lactate / Potssium Chloride / Calcium Chloride in Water Baxter Healthcare Fresenius Kabi
1/28/2019 Cleocin T Clindamycin Phosphate Pharmacia and Upjohn Encube Ethicals
1/28/2019 DDAVP Desmopressin Acetate Ferring Pharms Abhai
1/28/2019 Wellbutrin XL Bupropion HCl Valeant Graviti Pharms
1/28/2019 Rapamune Sirolimus PF Prism Novitium Pharma
1/29/2019 Vazculep Phenylephrine HCl West-Ward Pharm / Avadel Legacy Fresenius Kabi
1/30/2019 Advair Wixela Inhub Glaxo  Mylan
1/30/2019 Vazculep Phenylephrine HCl Avadel Legacy Fresenius Kabi
1/30/2019 Desonide Desonide Perrigo Encube Ethicals
1/30/2019 Onfi Clobazam Lundbeck Micro Labs
1/31/2019 Vazculep Phenylephrine HCl West-Ward Pharm / Avadel Legacy Sandoz
1/31/2019 Protopic Tacrolimus Leo Pharma Accord Healthcare
2/1/2019 Bentyl Dicyclomine HCl Allergan Nexus Pharms
2/1/2019 Ritalin Methylphenidate HCl Novartis Cediprof
2/4/2019 Trandate Labetalol HCl County Line Pharms Invatech Pharma
2/4/2019 Zovirax Acyclovir Bausch & Lomb Perrigo
2/4/2019 Fetzima Levomilnacipran HCl Allergan Amneal
2/4/2019 Oxycodone HCl Oxycodone HCl Genus Lifesciences Alkem Labs
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Aurobindo
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Hetero
2/5/2019 Adcirca Alyq Eli Lilly and Co Teva
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Dr Reddy's Labs
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Cipla
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Ajanta Pharma
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Lupin
2/5/2019 Vivelle-Dot Estradiol Novartis Amneal
2/6/2019 Seasonale Sylevia Teva  Sun Pharm
2/7/2019 Tegretol-XR Carbamazepine Novartis Zydus
2/7/2019 Nicorette Nicotine Polacrilex GlaxoSmithKline PLD Acquisitions
2/7/2019 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Accord Healthcare
2/7/2019 Oxycodone HCl Oxycodone HCl Genus Lifesciences / VistaPharm Alkem Labs
2/8/2019 Renagel Sevelamer HCl Genzyme Glenmark
2/8/2019 Gleevec Imatinib Mesylate Novartis Breckenridge
2/8/2019 Gleevec Imatinib Mesylate Novartis Amneal
2/8/2019 Ferriprox Deferiprone Apopharma Taro Pharm
2/8/2019 Syprine Trientine HCl Aton Amneal
2/8/2019 Colcrys Colchicine Takeda Alkem Labs
2/8/2019 Fluoxetine HCl Fluoxetine HCl Alvogen Lupin
2/8/2019 Lipitor Atorvastatin Calcium Pfizer MSN Labs
2/11/2019 Dyazide Triamterene and Hydrochlorothiazide GlaxoSmithKline Zydus
2/11/2019 Omeprazole Omeprazole (OTC) Dexcel Pharma Apotex
2/11/2019 Triamcinolone Acetonide Triamcinolone Acetonide Mylan Strides Pharma
2/11/2019 Bentyl Dicyclomine HCl Allergan Custopharm
2/12/2019 CellCept Mycophenolate Mofetil Roche VistaPharm
2/13/2019 Vigamox Moxifloxacin HCl Novartis  Alembic Pharms
2/13/2019 Synalar Fluocinolone Acetonide Medimetriks Pharms Encube Ethicals
2/14/2019 DDAVP Desmopressin Acetate Ferring Luitpold
2/14/2019 Gemcitabine HCl Gemcitabine HCl Hospira Ingenus Pharms
2/14/2019 Advil PM Ibuprofen / Diphenhydramine HCl Pfizer Aurobindo Pharma
2/15/2019 Eloxatin Oxaliplatin Sanofi Aventis  / Teva Sun Pharma
2/15/2019 Actonel Risedronate Sodium Apil Hangzhou Binjiang
2/15/2019 Olux Clobetasol Propionate Mylan Glenmark
2/19/2019 Micardis Telmisartan Boehringer Ingelheim Hisun Pharm Hangzhou
2/19/2019 Diamox Acetazolamide Teva  Alembic Pharms
2/19/2019 Levo-T / Levoxyl / Synthroid / Unithroid Levothyroxine Sodium Cediprof / King Pharms / AbbVie / Stevens Amneal
2/19/2019 Marcaine Bupivacaine HCl Hospira Novocol Healthcare
2/19/2019 Colcrys Colchicine Takeda Zydus
2/19/2019 Zarontin Ethosuximide Parke Davis Strides
2/20/2019 Zovirax Acyclovir Bausch & Lomb Perrigo
2/20/2019 Nimbex Cisatracurium Besylate Preservative Free AbbVie Somerset Theraps
2/20/2019 Mephyton Phytonadione Bausch & Lomb Zydus
2/21/2019 Rocaltrol Calcitriol Validus Pharms Sun Pharm
2/21/2019 Abilify Aripiprazole Otsuka Alkem Labs
2/21/2019 Aromasin Exemestane Pharmacia and Upjohn Breckenridge
2/22/2019 Niaspan Niacin AbbVie Mylan
2/22/2019 Antivert Meclizine HCl Casper Pharma Indicus Pharma
2/22/2019 Gemzar Gemcitabine HCl Eli Lilly and Co Shilpa Medicare
2/22/2019 Medrol Methylprednisolone Pharmacia and Upjohn Lupin
2/22/2019 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Acic Pharms
2/22/2019 Busulfex Busulfan Otsuka Accord Healthcare
2/22/2019 Benicar Olmesartan Medoxomil Daiichi Sankyo Sunshine Lake
2/22/2019 Tessalon Benzonatate Pfizer Ascent Pharms
2/22/2019 Clolar Clofarabine Genzyme Accord Healthcare
2/25/2019 Flagyl I.V. RTU in Plastic Container / Metro I.V. in Plastic Container / Metronidazole in Plastic Container Metronidazole in Plastic Container Baxter Healthcare / B Braun / Hospira Inforlife
2/25/2019 Lovaza Omega-3-Acid Ethyl Esters SmithKline Beecham Ascent Pharms
2/25/2019 Zytiga Abiraterone Acetate Janssen Rising Pharms
2/26/2019 Zithromax Azithromycin Pfizer Bionpharma
2/26/2019 Zithromax Azithromycin Pfizer Bionpharma
2/27/2019 Zytiga Abiraterone Acetate Janssen Wockhardt
2/27/2019 Vidaza Azacitidine Celgene Lupin
2/27/2019 Tamiflu Oseltamivir Phosphate Roche Teva
2/28/2019 Ditropan XL Oxybutynin Chloride Janssen Ajanta
3/1/2019 Perphenazine Perphenazine Sandoz Rising Pharms
3/1/2019 Crestor Rosuvastatin Calcium IPR Zydus
3/1/2019 Gleevec Imatinib Mesylate Novartis Natco Pharma
3/1/2019 Protonix Pantoprazole Sodium Wyeth Ingenus Pharms
3/4/2019 Micardis HCT Telmisartan / Hydrochlorothiazide Boehringer Ingelheim Glenmark
3/4/2019 Exelon Rivastigmine Novartis Zydus
3/4/2019 Faslodex Fulvestrant AstraZeneca Amneal
3/5/2019 Epivir Lamivudine ViiV Healthcare Mylan
3/5/2019 Bepreve Bepotastine Besilate Bausch and Lomb Apotex
3/5/2019 Nexium 24Hr Esomeprazole Magnesium AstraZeneca Actavis
3/5/2019 Kapvay Clonidine HCl Concordia Pharms Novast Labs
3/6/2019 Lipitor Atorvastatin Calcium Pfizer Lupin
3/8/2019 Tenoretic Atenolol and Chlorthalidone Alvogen Malta Zydus
3/8/2019 Mestinon Pyridostigmine Bromide Bausch Novitium Pharma
3/11/2019 Integrilin Eptifibatide Schering USV
3/11/2019 Micro-K / Micro-K 10 Potassium Chloride Nesher Pharms Zydus
3/11/2019 Ampyra Dalfampridine Acorda Micro Labs
3/12/2019 Diovan Valsartan Novartis Alkem
3/12/2019 Claritin Loratadine Bayer Healthcare Newgen Pharms
3/12/2019 Zanaflex Tizanidine HCl Covis Pharma RiconPharma
3/12/2019 Procardia XL Nifedipine Pfizer Novast Labs
3/12/2019 Zyloprim Allopurinol Casper Pharma Unichem Labs
3/12/2019 Desonide Desonide Perrigo Teligent Pharma
3/13/2019 Yasmin Kemeya Bayer Healthcare Sun Pharm
3/13/2019 Sodium Chloride 3% in Plastic Container Sodium Chloride 3% in Plastic Container Baxter Healthcare Fresenius Kabi
3/13/2019 Children's Zyrtec  Cetirizine HCl J and J Consumer Hetero Labs Ltd III
3/14/2019 Integrilin Epifibatide Schering USV
3/14/2019 Lovenox Enoxaparin Sodium Sanofi Aventis Amphastar
3/15/2019 Diovan HCT Valsartan / Hydrochlorothiazide Novartis Zydus
3/15/2019 Zovirax Acyclovir Bausch Zydua
3/18/2019 Bepreve Bepotastine Besilate Bausch and Lomb Micro Labs
3/18/2019 Lidex Fluocinonide County Line Pharms Teligent Pharma
3/19/2019 Invanz Ertapenem Sodium Merck Sharp Dohme Savior Lifetec
3/19/2019 Latuda Lurasidone HCl Sunovion Zydus
3/20/2019 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Lannett
3/20/2019 Naftin Naftifine HCl Sebela Tolmar
3/21/2019 Epivir-HBV Lamivudine GlaxoSmithKline Annora
3/22/2019 Tekturna Aliskiren Hemifumarate Noden Pharma Anchen Pharms
3/22/2019 Daliresp Roflumilast AstraZeneca Micro Labs
3/22/2019 Makena Preservative Free Hydroxyprogesterone Caproate Amag Pharma Slayback Pharma
3/22/2019 Yaz Drospirenone / Ethinyl Estradiol Bayer Healthcare Hetero
3/22/2019 Viagra Sildenafil Citrate Pfizer Lupin
3/25/2019 Viagra Sildenafil Citrate Pfizer Mylan
3/25/2019 Nuvigil Armodafinil Cephalon Apotex
3/26/2019 Baraclude Entecavir Bristol-Myers Squibb Mylan
3/26/2019 Cialis Tadalafil Eli Lilly and Co Alembic
3/26/2019 Cialis Tadalafil Eli Lilly and Co Aurobindo
3/26/2019 Cialis Tadalafil Eli Lilly and Co Zydus
3/26/2019 Cialis Tadalafil Eli Lilly and Co Sun Pharm
3/26/2019 Cialis Tadalafil Eli Lilly and Co Accord Healthcare
3/26/2019 Cialis Tadalafil Eli Lilly and Co Unichem Labs
3/26/2019 Cialis Tadalafil Eli Lilly and Co Cipla 
3/26/2019 Cialis Tadalafil Eli Lilly and Co Ajanta
3/26/2019 Cialis Tadalafil Eli Lilly and Co Amneal
3/26/2019 Cialis Tadalafil Eli Lilly and Co Hetero
3/26/2019 Cialis Tadalafil Eli Lilly and Co Dr Reddy's Labs
3/26/2019 Cialis Tadalafil Eli Lilly and Co Qilu Pharm
3/26/2019 Cialis Tadalafil Eli Lilly and Co Lupin
3/26/2019 Cialis Tadalafil Eli Lilly and Co Sunshine Lake
3/26/2019 Cialis Tadalafil Eli Lilly and Co Torrent
3/26/2019 Adcirca Tadalafil Eli Lilly and Co Torrent
3/26/2019 Zanaflex Tizanidine HCl Covis Pharma Cadila
3/27/2019 Zanaflex Tizanidine HCl Covis Pharma Alkem Labs
3/28/2019 Letairis Ambrisentan Gilead Watson
3/28/2019 Letairis Ambrisentan Gilead Mylan
3/28/2019 Letairis Ambrisentan Gilead Zydus
3/28/2019 Letairis Ambrisentan Gilead Sun Pharm
3/28/2019 Xyzal Allergy 24Hr Levocetirizine Dihydrochloride Sanofi Avenits Perrigo
3/29/2019 Cialis Tadalafil Eli Lilly and Co Watson
3/29/2019 Azilect Rasagiline Mesylate Teva Micro Labs
3/29/2019 Potassium Chloride Potassium Chloride Genus Lifesciences Pharm Assoc
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