ANDA Approvals Summer 2018 | Hatch-Waxman | Robins Kaplan LLP Law Firm

Summer 2018

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
4/5/2018	Loprox	Ciclopirox	Medicis	Teligent Pharma
4/6/2018	Invega	Paliperidone	Janssen	Sun Pharma
4/6/2018	Zovirax	Acyclovir	Valeant	Alembic
4/9/2018	Fazaclo ODT	Clozapine	Jazz	Barr Labs
4/9/2018	Diovan	Valsartan	Novartis	Square Pharms
4/9/2018	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Mylan
4/9/2018	Zithromax	Azithromycin	Pfizer	Epic Pharma
4/9/2018	Miralax	Polyethylene Glycol 3350 (OTC)	Bayer	Aurobindo
4/11/2018	Cubicin	Daptomycin	Cubist Pharms	Fresenius Kabi USA
4/11/2018	Atacand HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharms	Prinston
4/11/2018	Dopamine HCl	Dopamine HCl	Hospira	Hikma
4/11/2018	Claritin / Claritin Hives Relief	Loratadine (OTC)	Bayer	Aurobindo
4/11/2018	Dermotic	Flac	Hill Dermac	Patrin Pharma
4/12/2018	Zortress	Everolimus	Novartis	West-Ward Pharms
4/13/2018	Pravachol	Pravastatin Sodium	Bristol-Myers Squibb	Appco Pharma
4/16/2018	Adenocard	Adenosine	Astellas	Fresenius Kabi USA
4/16/2018	Claritin / Claritin Hives Relief	Loratadine (OTC)	Bayer	Aurobindo Pharma
4/16/2018	Invanz	Ertapenem Sodium	Merck Sharp & Dohme	ACS Dobfar Spa
4/16/2018	Children's Claritin	Loratadine (OTC)	Bayer	Sun Pharma Global
4/16/2018	Protopic	Tacrolimus	Leo Pharma	Glenmark Pharms
4/17/2018	Avapro	Irbesartan	Sanofi Aventis	Amneal
4/17/2018	Morphine Sulfate	Morphine Sulfate	West-Ward Pharms	ANI Pharms
4/17/2018	Parnate	Tranylcypromine Sulfate	Concordia Pharms	Kinedexe
4/17/2018	Actos	Pioglitazone HCl	Takeda	Prinston
4/17/2018	Zavesca	Miglustat	Actelion Pharms	Amerigen Pharms
4/17/2018	Cardura	Doxazosin Mesylate	Pfizer	Appco Pharma
4/17/2018	Children's Motrin	Ibuprofen (OTC)	Johnson and Johnson Consumer	Aurobindo
4/17/2018	Robaxin	Methocarbamol	West-Ward Pharms	Fresenius Kabi USA
4/17/2018	Clobex	Clobetasol Propionate	Galderma Labs	Apotex
4/17/2018	Xeloda	Capecitabine	Hoffmann La Roche	Eugia Pharma
4/18/2018	Xylocaine / Xylocaine Preservative Free	Lidocaine HCl	Fresenius Kabi USA	Spectra Medical Devices
4/18/2018	Spectazole	Econazole Nitrate	Alvogen Malta	Mylan
4/19/2018	Epivir	Lamivudine	ViiV Healthcare	Strides
4/20/2018	Xenazine	Tetrabenazine	Valeant	Lupin
4/23/2018	Medrol	Methylprednisolone	Pharmacia and Upjohn	Zydus
4/23/2018	Sensipar	Cinacalcet HCl	Amgen	Zydus
4/23/2018	Lidex	Fluocinonide	County Line Pharms	Glasshouse Pharms
4/23/2018	Lidex	Fluocinonide	County Line Pharms	MacLeods Pharms
4/23/2018	Sabril	Vigabatrin	Lundbeck Pharms	Teva
4/24/2018	Aciphex	Rabeprazole Sodium	Eisai	Alkem Labs
4/26/2018	Treanda	Bendamustine HCl	Cephalon	Mylan
4/27/2018	Sustiva	Efavirenz	Bristol-Myers Squibb	Hetero Labs
4/27/2018	Dilaudid	Hydromorphone HCl	Fresenius Kabi USA	Eurohealth Int'l
4/27/2018	Aromasin	Exemestane	Pharmacia and Upjohn	Cipla
4/27/2018	Vazculep	Phenylephrine HCl	Avadel Legacy	Cipla
4/27/2018	Phenylephrine HCl	Phenylephrine HCl	West-Ward Pharm	Cipla
4/30/2018	Bumex	Bumetanide	Validus Pharms	Zydus Pharms
4/30/2018	Celebrex	Celecoxib	GD Searle	Micro Labs
4/30/2018	Docetaxel	Docetaxel	Hospira	Mylan
4/30/2018	Sensipar	Cinacalcet HCl	Amgen	Strides Pharma
4/30/2018	Nexium	Esomeprazole Magnesium	AstraZeneca	Sun Pharm
4/30/2018	Kapvay	Clonidine HCl	Concordia Pharms	Mayne Pharma
4/30/2018	Oxycodone HCl	Oxycodone HCl	Genus LifeSciences / Vistapharm	Specgx
5/1/2018	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharms	Appco Pharma
5/3/2018	Ciloxan	Ciprofloxacin HCl	Novartis	Altaire Pharms
5/4/2018	Norvasc	Amlodipine Besylate	Pfizer	Sunshine Lake
5/4/2018	Bentyl / Bentyl Preservative Free	Dicyclomine HCl	Allergan	Akorn
5/4/2018	Protonix IV	Pantoprazole Sodium	Wyeth	Mylan
5/4/2018	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy	Luitpold Pharms
5/4/2018	Diovan	Valsartan	Novartis	Unichem Labs
5/4/2018	Anectine / Quelicin & Quelicin Preservative Free	Succinylcholine Chloride	Sandoz / Hospira	Zydus Pharms
5/4/2018	Vidaza	Azacitidine	Celgene	Cipla
5/4/2018	Keppra	Levetiracetam	UCB	Akorn
5/4/2018	Revatio	Sildenafil Citrate	Pfizer	Ajanta Pharma
5/7/2018	Coreg CR	Carvedilol Phosphate	SmithKline Beecham	Impax Labs
5/7/2018	Plavix	Clopidogrel Bisulfate	Sanofi Aventis	Prinston
5/7/2018	Nitrostat	Nitroglycerin	Pfizer	SigmaPharm Labs
5/7/2018	Robaxin / Robaxin-750	Methocarbamol	Auxilium Pharms	Granules India
5/7/2018	Namenda	Memantine HCl	Allergan	CSPC Ouyi Pharm
5/7/2018	Cyclophosphamide	Cyclophosphamide	West-Ward Pharms	STI Pharma
5/7/2018	Lodosyn	Carbidopa	Aton	Zydus Pharms
5/8/2018	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharms	Alkaloida ZRT
5/8/2018	Edecrin	Ethacrynic Acid	Aton	Amneal
5/8/2018	Targretin	Bexarotene	Valeant	Amerigen Pharms
5/9/2018	Calcium Chloride 10% in Plastic Container	Calcium Chloride 10% in Plastic Container	Hospira	Int'l Medication Sys
5/11/2018	Zosyn	Piperacillin / Tazobactam	Wyeth	Fresenius Kabi
5/11/2018	Zosyn	Piperacillin / Tazobactam	Wyeth	Apollo Pharms
5/11/2018	Mephyton	Phytonadione	Valeant	Amneal
5/14/2018	Medrol	Methylprednisolone	Pharmacia and Upjohn	Tianjin Tianyao
5/14/2018	Neurontin	Gabapentin	Pfizer	ACI Healthcare
5/14/2018	Niaspan	Niacin	AbbVie	Jubilant Generics
5/15/2018	Arixtra	Fondaparinux Sodium	Mylan	Jiangsu Hengrui Med
5/15/2018	Nexium 24HR	Esomeprazole Magnesium (OTC)	AstraZeneca	Dr Reddys Labs
5/15/2018	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharms	Amneal
5/16/2018	Welchol	Colesevelam HCl	Daiichi Sankyo	Impax Labs
5/17/2018	Quillivant XR	Methylphenidate HCl	Nextwave Pharms	Actavis
5/17/2018	Actigall	Ursodiol	Allergan	Abhai
5/18/2018	Marinol	Dronabinol	AbbVie	Lannett
5/18/2018	Welchol	Colesevelam HCl	Daiichi Sankyo	Glenmark
5/18/2018	Zosyn	Piperacillin / Tazobactam	Wyeth	Fresenius Kabi
5/18/2018	Nexium	Esomeprazole Magnesium	AstraZeneca	HEC Pharm
5/18/2018	Triamcinolone Acetonide	Triamcinolone Acetonide	Mylan	MacLeods Pharms
5/22/2018	Cialis	Tadalafil	Eli Lilly	Teva
5/23/2018	Epiduo	Adapalene / Benzoyl Peroxide	Galderma Labs	Tolmar
5/24/2018	Jalyn	Dutasteride / Tamsulosin HCl	GlaxoSmithKline	Zydus Pharms
5/24/2018	Macrobid	Nitrofurantoin (Monohydrate/ Macrocrystals)	Alvogen Malta	Sunny Pharmatech
5/25/2018	Zegerid	Omeprazole / Sodium Bicarbonate	Santarus	Zydus Pharms
5/25/2018	Relpax	Eletriptan Hydrobromide	Pfizer	Ameal
5/25/2018	Benzaclin	Clindamycin Phosphate / Benzoyl Peroxide	Valeant	Taro
5/30/2018	Cardizem CD	Diltiazem HCl	Valeant	Par
5/31/2018	Tylenol	Acetaminophen (OTC)	Johnson and Johnson Consumer	Heritage Pharma
5/31/2018	Gelnique	Oxybutynin Chloride	Allergan	Par
5/31/2018	Vibramycin	Doxycycline Hyclate	Pfizer	Zydus Pharms
5/31/2018	Celebrex	Celecoxib	GD Searle	Amneal
6/1/2018	Angiomax	Bivalirudin	The Medicines Co	Mylan
6/1/2018	Corgard	Nadolol	US WorldMeds	RiconPharma
6/4/2018	Anectine / Quelicin & Quelicin Preservative Free	Succinylcholine Chloride	Sandoz / Hospira	Renaissance SSA
6/4/2018	Vanos	Fluocinonide	Medicis	Amneal
6/5/2018	Cubicin	Daptomycin	Cubist Pharms	Mylan
6/5/2018	Onexton	Clindamycin Phosphate / Benzoyl Peroxide	Dow Pharm	Taro
6/5/2018	Loestrin FE 1.5/30	Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate	Apil	Glenmark
6/5/2018	Loestrin FE 1.5/30	Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate	Apil	Glenmark
6/6/2018	Prilosec	Omeprazole Magnesium (OTC)	AstraZeneca	Aurobindo
6/8/2018	Zymaxid	Gatifloxacin	Allergan	Micro Labs
6/8/2018	Brevibloc	Esmolol HCl	Baxter Healthcare	Mylan
6/8/2018	Brevibloc	Esmolol HCl	Baxter Healthcare	Sagent Pharms
6/8/2018	Tamiflu	Oseltamivir Phosphate	Roche	Strides Pharma
6/11/2018	Viagra	Sildenafil Citrate	Pfizer	Torrent
6/11/2018	Viagra	Sildenafil Citrate	Pfizer	Hetero Labs
6/11/2018	Viagra	Sildenafil Citrate	Pfizer	Aurobindo
6/11/2018	Viagra	Sildenafil Citrate	Pfizer	Rubicon Research
6/11/2018	Naropin	Ropivacaine HCl	Fresenius Kabi USA	Inforlife
6/12/2018	Paxil CR	Paroxetine HCl	Apotex	Sciecure Pharma
6/12/2018	Isuprel	Isoproterenol HCl	Hospira	Cipla
6/13/2018	Vibramycin	Doxycycline Hyclate	Pfizer	Alembic Pharms
6/14/2018	Suboxone	Buprenorphine HCl / Naloxone HCl	Indivior	Dr Reddy's Labs
6/14/2018	Suboxone	Buprenorphine HCl / Naloxone HCl	Indivior	Dr Reddy's Labs
6/14/2018	Suboxone	Buprenorphine HCl / Naloxone HCl	Indivior	Mylan
6/14/2018	Wellbutrin XL	Bupropion HCl	Valeant	Yichang Humanwell
6/15/2018	Sustiva	Efavirenz	Bristol-Myers Squibb	Cipla
6/15/2018	Naropin	Ropivacaine HCl	Fresenius Kabi USA	Somerset Therapeutics
6/15/2018	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy	Amneal
6/18/2018	Starlix	Nateglinide	Novartis	Indicus Pharma
6/18/2018	Ancobon	Flucytosine	Valeant	Recipharm
6/18/2018	Lipitor	Atorvastatin Calcium	Pfizer	Graviti Pharms
6/18/2018	Isuprel	Isoproterenol HCl	Hospira	Amphastar Pharms
6/19/2018	Effient	Prasugrel	Eli Lilly	Amneal
6/19/2018	Fluocinonide	Fluocinonide	County Line Pharms	Teligent Pharma
6/20/2018	Exelon	Rivastigmine	Novartis	Mylan
6/21/2018	Sabril	Vigadrone	Lundbeck Pharms	Aucta Pharms
6/21/2018	Makena Preservative Free	Hydroxyprogesterone Caproate	Amag Pharma	Luitpold Pharms
6/22/2018	Estrostep FE	Norethindrone Acetate / Ethinyl Estradiol	Apil	Mylan
6/22/2018	Avodart	Dutasteride	GlaxoSmithKline	Pharmaceutics
6/22/2018	Cipro	Ciprofloxacin HCl	Bayer	Yiling Pharm
6/22/2018	Klor-Con	Potassium Chloride	Upsher-Smith	Yichang Humanwell
6/25/2018	Reyataz	Atazanavir Sulfate	Bristol-Myers Squibb	Aurobindo
6/25/2018	Invanz	Ertapenem Sodium	Merck Sharp & Dohme	Aurobindo
6/26/2018	Nicorette	Nicotine Polacrilex (OTC)	GlaxoSmithKline	Watson
6/27/2018	Depo-Medrol	Methylprednisolone Acetate	Pharmacia and Upjohn	Sagent Pharms
6/27/2018	Viagra	Sildenafil Citrate	Pfizer	Amneal
6/28/2018	Cancidas	Caspofungin Acetate	Merck	Sandoz
6/29/2018	Atelvia	Risedronate Sodium	Apil	Impax Labs
6/29/2018	Zometa	Zoledronic	Novartis	Gland Pharma
6/29/2018	Zometa	Zoledronic Acid	Novartis	Gland Pharma
6/29/2018	EMLA	Lidocaine / Prilocaine	Actavis	Teligent Pharma
6/29/2018	Seasonale	Icelevia	Teva	Aurobindo
6/29/2018	Motrin IB	Ibuprofen (OTC)	Johnson and Johnson Consumer	Strides Pharma
6/29/2018	Advil Liqui-Gels / Advil Migraine Liqui-Gels	Ibuprofen	Pfizer	Aurobindo
6/29/2018	Benicar	Olmesartan Medoxomil	Daiichi Sankyo	Sciegen Pharms
6/29/2018	Maxzide-25 / Maxzide	Triamterene / Hydrochlorothiazide	Mylan	Zydus Pharms
6/29/2018	Claritin	Loratadine (OTC)	Bayer	Aurobindo
6/29/2018	Adalat CC	Nifedipine	Alvogen	Zydus Pharms

GENERICally Speaking Summer 2018

Oren D. Langer

Partner

Managing Partner, New York Office

Jeffrey Alan Hovden

Partner