ANDA Approvals

Winter 2019

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
10/1/2018	Pristiq	Desvenlafaxine Succinate	PF Prism CV	Yichang Humanwell
10/2/2018	Inomax	Noxivent	Mallinckrodt	Praxair Distribution
10/3/2018	Aromasin	Exemestane	Pharmacia and Upjohn	Zydus
10/3/2018	Comtan	Entacapone	Orion Pharma	Sunshine Lake
10/3/2018	Daliresp	Roflumilast	AstraZeneca	Breckenridge
10/3/2018	Methylin	Methylphenidate HCl	Specgx	Wes Pharma
10/3/2018	Minipress	Prazosin HCl	Pfizer	Novitium Pharma
10/3/2018	Mirapex	Pramipexole Dihydrochloride	Boehringer Ingelheim	CSPC Ouyi Pharm
10/4/2018	Olux	Clobetasol Propionate	Mylan	Taro Pharm
10/4/2018	Levophed	Norepinephrine Bitartrate	Hospira	Mylan
10/5/2018	Welchol	Colesevelam HCl	Daiichi Sankyo	Alkem
10/5/2018	Kenalog-40	Triamcinolone Acetonide	Apothecon	Teva
10/5/2018	Welchol	Colesevelam HCl	Daiichi Sankyo	Dr Reddy's Labs
10/9/2018	Latisse	Bimatoprost	Allergan	Hi-Tech Pharmacal
10/9/2018	Zithromax	Azithromycin	Pfizer	Hainan Poly Pharm
10/9/2018	Zemplar	Paricalcitol	AbbVie	Aurobindo
10/9/2018	Tikosyn	Dofetilide	Pfizer	Par
10/9/2018	Zithromax	Azithromycin	Pfizer	Aurobindo
10/9/2018	Focalin XR	Dexmethylphenidate HCl	Novartis	Adare Pharms
10/9/2018	Tikosyn	Dofetilide	Pfizer	Sun
10/9/2018	Suprax	Cefixime	Lupin	Alkem
10/10/2018	Aggrenox	Aspirin / Dipyridamole	Boehringer Ingelheim	Dr Reddy's Labs
10/11/2018	Sensipar	Cinacalcet HCl	Amgen	Sun
10/11/2018	Mepron	Atovaquone	GlaxoSmithKline	Hetero Labs
10/12/2018	Viagra	Sildenafil Citrate	Pfizer	Ajanta
10/12/2018	Omeprazole	Omeprazole (OTC)	Dexcel Pharma	Sun
10/12/2018	Glucophage	Metformin HCl	Bristol-Myers Squibb	Sunshine Lake
10/12/2018	Betamethasone Dipropionate	Betamethasone Dipropionate	Fougera Pharms	G and W Labs
10/12/2018	Depo-Provera	Medroxyprogesterone Acetate	Pharmacia and Upjohn	Mylan
10/12/2018	Kapvay	Clonidine HCl	Concordia Pharms	Upsher-Smith Labs
10/16/2018	Sensipar	Cinacalcet HCl	Amgen	Mylan
10/16/2018	Rilutek	Riluzole	Covis Pharma	Daito Pharms
10/16/2018	Eloxatin	Oxaliplatin	Sanofi Aventis / Teva	Ingenus Pharms
10/16/2018	Crestor	Rosuvastatin Calcium	IPR	Amneal
10/16/2018	BICNU	Carmustine	Emcure Pharms	Amneal
10/16/2018	Actigall	Ursodiol	Allergan	Amneal
10/16/2018	Cymbalta	Duloxetine HCl	Eli Lilly	CSPC Ouyi Pharm
10/16/2018	Neurontin	Gabapentin	Eli Lilly	Strides
10/16/2018	Wellbutrin SR	Bupropion HCl	GlaxoSmithKline	Yichang Humanwell
10/16/2018	Fluocinonide	Fluocinonide	Taro	Teligent Pharma
10/17/2018	Prevacid	Lansoprazole	Takeda	Breckenridge
10/17/2018	Epiduo Forte	Adapalene / Benzoyl Peroxide	Galderma Labs	Taro
10/17/2018	Isuprel	Isoproterenol HCl	Hospira	Amneal
10/18/2018	Capastat Sulfate	Capreomycin Sulfate	Akorn	Hisun Pharm Hangzhou
10/18/2018	Diamox	Acetazolamide	Teva	Accord Healthcare
10/18/2018	Levophed	Norepinephrine Bitartrate	Hospira	Sandoz
10/22/2018	Glucophage XR	Metformin HCl	Bristol-Myers Squibb	Alkem
10/22/2018	Onfi	Clobazam	Lundbeck	West-Ward Pharms
10/22/2018	Onfi	Clobazam	Lundbeck	Bionpharma
10/22/2018	Onfi	Clobazam	Lundbeck	Breckenridge
10/22/2018	Onfi	Clobazam	Lundbeck	Taro Pharm
10/22/2018	Onfi	Clobazam	Lundbeck	Upsher-Smith Labs
10/22/2018	Onfi	Clobazam	Lundbeck	West-Ward Pharms
10/22/2018	Onfi	Clobazam	Lundbeck	Amneal
10/22/2018	Onfi	Clobazam	Lundbeck	Hetero Labs
10/22/2018	Onfi	Clobazam	Lundbeck	Piramal
10/22/2018	Onfi	Clobazam	Lundbeck	Upsher-Smith Labs
10/22/2018	Onfi	Clobazam	Lundbeck	Mylan
10/22/2018	Onfi	Clobazam	Lundbeck	Zydus
10/23/2018	Aleve PM	Naproxen Sodium / Diphenhydramine Hydrochloride (OTC)	Bayer	Amneal
10/23/2018	Topicort	Desoximetasone	Taro Pharm	Teligent Pharma
10/24/2018	Ampyra	Dalfampridine	Acorda	West-Ward Pharms
10/25/2018	Zithromax	Azithromycin	Pfizer	CSPC Ouyi Pharm
10/25/2018	Ritalin	Methylphenidate HCl	Novartis	Aurolife Pharma
10/25/2018	Renvela	Sevelamer Carbonate	Genzyme	Dr Reddy's Labs
10/25/2018	Derma-Smoothe/FS	Flucinolone Acetonide	Hill Dermac	Glenmark
10/26/2018	Toprol-XL	Metoprolol Succinate	Aralez Pharms	Cipla
10/26/2018	Aubagio	Teriflunomide	Sanofi Aventis	Aurobindo
10/26/2018	Derma-Smooth/FS	Fluocinonide Acetonide	Hill Dermac	Glenmark
10/26/2018	Prometrium	Progesterone	Virtus Pharms	Eugia Pharma
10/26/2018	Clobex	Clobetasol Propionate	Galderma Labs	Hi-Tech Pharmacal
10/26/2018	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Amneal
10/26/2018	Robaxin	Methocarbamol	West-Ward Pharms	Gland Pharma
10/26/2018	Cytomel	Liothyronine Sodium	King Pharms	Teva
10/26/2018	Zetia	Ezetimibe	Merck Sharp & Dome	Accord Healthcare
10/30/2018	Urso 250	Ursodiol	Allergan	Zydus
10/31/2018	Clolar	Clofarabine	Genzyme	Gland Pharma
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Hikma
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Teva
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Mylan
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Apotex
10/31/2018	Anafranil	Clomipramine HCl	Specgx	Amneal
10/31/2018	Levitra	Vardenafil HCl	Bayer	Zydus
10/31/2018	Levitra	Vardenafil HCl	Bayer	CrossMedika
10/31/2018	Wellbutrin XL	Bupropion HCl	Valeant	Accord Healthcare
10/31/2018	Levitra	Vardenafil HCl	Bayer	Amneal
11/1/2018	Mucinex DM	Guaifenesin / Dextromethorphan Hydrobromide (OTC)	RB Hlth	Ameal
11/1/2018	Hectorol	Doxercalciferol	Hospira / Sanofi	Lupin
11/2/2018	Bentyl	Dicyclomine HCl	Allergan	Renaissance
11/2/2018	Betapace AF	Sotalol HCl	Covis Pharma	Beximco Pharms
11/2/2018	Aubagio	Teriflunomide	Sanofi Aventis	Apotex
11/2/2018	Fortamet	Metformin HCl	Andrx Labs	Novast Labs
11/5/2018	Cleocin Hydrochloride	Clindamycin HCl	Pharmacia and Upjohn	Micro Labs
11/5/2018	Omeprazole	Omeprazole (OTC)	Dexcel Pharma	Dr Reddy's Labs
11/5/2018	Xopenex	Levalbuterol HCl	Oak Pharms	Sun
11/5/2018	Synalar	Fluocinolone Acetonide	Medimetriks Pharms	G and W Labs
11/6/2018	Aloxi	Palonosetron HCl	Helsinn Healthcare	Aurobindo
11/6/2018	Frova	Frovatriptan Succinate	Endo Pharms	Amneal
11/7/2018	Levophed	Norepinephrine Bitartrate	Hospira	Hikma
11/7/2018	Achromycin V	Tetracycline HCl	Heritage Pharms	Breckenridge
11/8/2018	Cytovene	Ganciclovir	Roche	Hainan Poly Pharm
11/9/2018	Atripla	Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead Sciences	Teva
11/9/2018	Arimidex	Anastrozole	ANI Pharms	Beijing Yiling
11/9/2018	Valcyte	Valganciclovir HCl	Roche	Cipla
11/9/2018	Tessalon	Benzonatate	Pfizer	Aiping Pharm
11/9/2018	Dacogen	Decitabine	Otsuka	Lupin
11/9/2018	Pulmicort Respules	Budesonide	AstraZeneca	Lupin
11/13/2018	Lomotil	Diphenoxylate HCl / Atropine Sulfate	GD Searle	Bayshore Pharms
11/14/2018	Femara	Letrozole	Novartis	Beijing Yiling
11/14/2018	Arixtra	Fondaparinux Sodium	Mylan	Scinopharm
11/15/2018	Epzicom	Abacavir Sulfate / Lamivudine	ViiV Healthcare	Aurobindo Pharma
11/15/2018	Diprivan	Propofol	Fresenius Kabi USA	Dr Reddy's Labs
11/15/2018	Acular LS	Ketorolac Tromethamine	Allergan	Aurobindo Pharma
11/15/2018	Epzicom	Abacavir Sulfate / Lamivudine	ViiV Healthcare	Zydus
11/15/2018	Aubagio	Teriflunomide	Sanofi Aventis	Glenmark
11/16/2018	Aleve	Naproxen Sodium (OTC)	Bayer	Novelgenix Theraps
11/16/2018	Staxyn	Vardenafil HCl	Bayer	Alembic Pharms
11/16/2018	Zyrtec-D 12 Hour	Cetirizine HCl / Pseudoephedrine HCl (OTC)	Johnson and Johnson	Perrigo
11/16/2018	Anectine / Quelicin	Succinylcholine Chloride	Sandoz / Hospira	Amneal
11/19/2018	Zometa	Zoledronic Acid	Novartis	Dr Reddy's Labs
11/19/2018	Finacea	Azelaic Acid	Leo Pharma	Glenmark
11/19/2018	Zyprexa	Olanzapine	Eli Lilly	Sunshine Lake
11/19/2018	Finacea	Azelaic Acid	Leo Pharma	Actavi
11/19/2018	Finacea	Azelaic Acid	Leo Pharma	Tolmar
11/19/2018	Abreva	Docosanol (OTC)	GlaxoSmithKline	Actavis
11/20/2018	Lialda	Mesalamine	Shire	Mylan
11/20/2018	Butrans	Buprenorphine	Purdue Pharma	Teva
11/20/2018	Lipitor	Atorvastatin Calcium	Pfizer	Zydus
11/20/2018	Sabril	Vigabatrin	Lundbeck	Dr Reddy's Labs
11/20/2018	Xyzal Allergy 24Hr	Levocetirizine Dihydrochloride (OTC)	Sanofi Aventis	Micro Labs
11/21/2018	Anafranil	Clomipramine HCl	Specgx	Lupin
11/21/2018	Voltaren	Diclofenac Sodium	GlaxoSmithKline	Hi-Tech Pharmacal
11/21/2018	Mepron	Atovaquone	GlaxoSmithKline	Glenmark
11/21/2018	Rocaltrol	Calcitriol	Validus Pharms	Invatech Pharma
11/21/2018	Potassium Chloride	Potassium Chloride	Pharma Res Software	Novel Labs
11/21/2018	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Appco Pharma
11/23/2018	Effexor XR	Venlafaxine HCl	Wyeth	Intellipharmaceutics
11/23/2018	Pravachol	Pravastatin Sodium	Bristol-Myers Squibb	Hisun Pharm Hangzhou
11/23/2018	Daliresp	Roflumilast	AstraZeneca	Hetero Labs
11/23/2018	Integrilin	Eptifibatide	Schering	Celerity Pharms
11/23/2018	Potassium Chloride	Potassium Chloride	Pharma Res Software	Epic Pharma
11/23/2018	Children's Motrin	Ibuprofen (OTC)	Johnson and Johnson	Aptapharma
11/23/2018	Restoril	Temazepam	Specgx	Alembic
11/26/2018	Prevacid	Lansoprazole	Takeda	Zydus
11/27/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead Sciences	Mylan
11/27/2018	Amicar	Aminocaproic Acid	Clover Pharms	Sunny Pharmtech
11/28/2018	Prevacid	Lansoprazole	Takeda	Mylan
11/29/2018	Renvela	Sevelamer Carbonate	Sanofi	Wilshire Pharms
11/29/2018	Precedex	Dexmedetomidine HCl	Hospira	Fresenius Kabi USA
11/29/2018	Mitigare	Colchicine	Hikm	Par
11/29/2018	Lidex	Fluocinonide	County Line Pharms	Encube Ethicals
11/30/2018	Ganirelix Acetate	Ganirelix Acetate	Organon USA	Sun
11/30/2018	Lamictal XR	Lamotrigine	GlaxoSmithKline	Amneal
11/30/2018	Aubagio	Teriflunomide	Sanofi Aventis	Zydus
11/30/2018	Vfend	Voriconazole	PF Prism CV	Hainan Poly Pharm
12/3/2018	Rapaflo	Silodosin	Allergan	Lupin
12/3/2018	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	Sciegen Pharms
12/3/2018	Rapaflo	Silodosin	Allergan	Amneal
12/3/2018	Rapaflo	Silodosin	Allergan	MSN Labs
12/3/2018	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Teva
12/3/2018	Rapaflo	Silodosin	Allergan	Ajanta
12/3/2018	Rapaflo	Silodosin	Allergan	MacLeods
12/4/2018	Fareston	Toremifene Citrate	Kyowa Kirin	Eirgen Pharma
12/4/2018	Atacand	Candesartan Cilexetil	ANI Pharms	Alembic
12/6/2018	Singulair	Montelukast Sodium	Merck Sharp & Dome	Cipla
12/6/2018	Zithromax	Azithromycin	Pfizer	Sunshine Lake
12/6/2018	Progesterone	Progesterone	Actavis	Eugia Pharma
12/7/2018	Lotrel	Amlodipine Besylate / Benazepril HCl	Novartis	Cipla
12/7/2018	Zithromax	Azithromycin	Pfizer	Sunshine Lake
12/7/2018	Zithromax	Azithromycin	Pfizer	Sunshine Lake
12/7/2018	Patanol	Olopatadine HCl	Novartis	Alembic
12/7/2018	Albenza	Albendazole	Impax	Strides Vivimed
12/10/2018	Rapaflo	Silodosin	Allergan	Aurobindo
12/13/2018	Aptensio XR	Methylphenidate HCl	Rhodes Pharms	Actavis
12/14/2018	Albenza	Albendazole	Impax Labs	Zydus
12/14/2018	Onfi	Clobazam	Lundbeck	Lupin
12/14/2018	Heparin Sodium	Heparin Sodium	West-Ward Pharms Int / Fresenius Kabi USA	Nanjing King-Friend
12/14/2018	Dermotic	Fluocinonide Acetonide	Hill Dermac	Glenmark
12/17/2018	Levophed	Norepinephrin Bitartrate	Hospira	Amneal
12/18/2018	Cyanocobalamin	Cyanocobalamin	Luitpold	Vitruvias Therap
12/18/2018	Cyanocobalamin	Cyanocobalamin	Luitpold	Somerset Therapeutics
12/19/2018	Tessalon	Benzonatate	Pfizer	Puracap Pharm
12/19/2018	Mirapex	Pramipexole Dihydrochloride	Boehringer Ingelheim	Unichem Labs
12/19/2018	Toprol-XL	Metoprolol Succinate	Aralez Pharms	Twi
12/19/2018	Klor-Con	Potassium Chloride	Upsher Smith Labs	Aurobindo
12/21/2018	Claritin	Loratadine (OTC)	Bayer	Bionpharma
12/21/2018	Tygacil	Tigecycline	PF Prism CV	Apotex
12/21/2018	Golytely	Polyethylene Glycol 3350 and Electrolytes	Braintree	Strides
12/21/2018	Doryx	Doxycycline Hyclate	Mayne Pharma	Zydus
12/21/2018	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA	Maia Pharms
12/21/2018	Lipitor	Atorvastatin Calcium	Pfizer	The Pharma Network
12/21/2018	Vazculep	Phenylephrine HCL	West-Ward Pharm Corp / Avadel Legacy	Par Sterile
12/26/2018	Gris-PEG	Griseofulvin, Ultramicrosize	Valeant	Sandoz
12/26/2018	Zithromax	Azithromycin	Pfizer	Bionpharma
12/27/2018	Sensipar	Cinacalcet HCl	Amgen	Teva
12/27/2018	Sandostatin	Octreotide Acetate	Novartis	USV North America
12/27/2018	Elidel	Pimecrolimus	Valeant	Actavis
12/27/2018	Fortamet	Metformin HCl	Andrx Labs	Qingdao Baheal
12/27/2018	Clolar	Clofarabine	Genzyme	Hospira
12/28/2018	Aromasin	Exemestane	Pharmacia and Upjohn	Amneal
12/28/2018	Camptosar	Irinotecan HCl	Pfizer	Shilpa Medicare
12/28/2018	Onfi	Clobazam	Lundbeck	Lupin
12/28/2018	Makena	Hydroxyprogesterone Caproate	Amag Pharma USA	Slayback Pharma
12/28/2018	Duac	Clindamycin Phosphate / Benzoyl Peroxide	Stiefel	Zydus
12/31/2018	Rogaine	Minoxidil	Johnson and Johnson	Taro Pharm

GENERICally Speaking Winter 2019

Oren D. Langer

Partner

Managing Partner, New York Office

Jeffrey Alan Hovden

Partner

Christopher A. Pinahs

Partner

GENERICally Speaking - Vol. 8, No. 4

VIEW FULL NEWSLETTER

First Quarter

ANDA Litigation Settlements