ANDA Approvals

Summer 2014

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant

4/1/2014

Lasix

Furosemide

Sanofi Aventis US

Caraco

4/2/2014

Kapvay

Clonidine Hydrochloride

Concordia Pharms

Anchen Pharms

4/2/2014

Entocort EC

Budesonide

AstraZeneca

Barr Labs Div Teva

4/2/2014

Vesicare

Solifenacin Succinate

Astellas

Teva

4/3/2014

Viramune XR

Nevirapine

Boehringer Ingelheim

Apotex

4/3/2014

Viramune XR

Nevirapine

Boehringer Ingelheim

Sandoz

4/3/2014

Avelox

Moxifloxacin Hydrochloride

Bayer Healthcare

Torrent Pharms

4/3/2014

Procardia XL

Nifedipine

Pfizer

TWi Pharms

4/4/2014

Valtrex

Valacyclovir Hydrochloride

GlaxoSmithKline

Apotex

4/7/2014

Nafcillin Sodium

Nafcillin Sodium

Sandoz

Agila Specialties

4/7/2014

Unasyn

Ampicillin / Sulbactam

Pfizer

Agila Specialties

4/7/2014

Unasyn

Ampicillin / Sulbactam

Pfizer

Agila Specialties

4/7/2014

Ampicillin Sodium

Ampicillin Sodium

Sandoz

Agila Specialties

4/7/2014

Ultracet

Tramadol Hydrochloride / Acetaminophen

Janssen Pharms

Apotex

4/7/2014

Microzide

Hydrochlorothiazide

Watson Labs

Caraco

4/7/2014

Actos

Pioglitazone Hydrochloride

Takeda Pharms USA

Lupin

4/7/2014

Lovaza

Omega-3-Acid Ethyl Esters

SmithKline Beecham

Teva

4/7/2014

Nimodipine

Nimodipine

Banner Pharmacaps

ThePharmaNetwork

4/8/2014

Eloxatin / Oxaliplatin

Oxaliplatin

Sanofi Aventis US/Teva

Sun Pharma Global

4/9/2014

Zomig

Zolmitriptan

IPR

Invagen Pharms

4/9/2014

Ampicillin Sodium

Ampicillin Sodium

Sandoz

Strides Arcolab

4/11/2014

Xylocaine / Xylocaine Preservative Free

Lidocaine Hydrochloride

Fresenius Kabi USA

Agila Specialties

4/11/2014

Plavix

Clopidogrel

Sanofi Aventis

Amneal Pharms

4/14/2014

Imitrex

Sumatriptan Succinate

GlaxoSmithKline

Agila Specialties

4/14/2014

Intensol

Diazepam

Roxane

Lannett Holdings

4/15/2014

Altace

Ramipril

King Pharms

Accord Healthcare

4/15/2014

Lunesta

Eszopiclone

Sunovion Pharms

Dr Reddy's Labs

4/15/2014

Lunesta

Eszopiclone

Sunovion Pharms

Glenmark Generics

4/15/2014

Lunesta

Eszopiclone

Sunovion Pharms Inc

Roxane

4/16/2014

Ortho Evra

Xulane

Janssen Pharms

Mylan Technologies

4/17/2014

Dilantin

Phenytoin

Pfizer

Taro

4/22/2014

Reyataz

Atazanavir Sulfate

Bristol Myers Squibb

Teva

4/23/2014

Loestrin 24 Fe

Norethindrone / Ethinyl Estradiol / Ferrous Fumarate

Warner Chilcott

Famy Care

4/23/2014

Aldactone

Spironolactone

GD Searle

Jubilant Life

4/23/2014

Niaspan

Niacin

Abbvie

Sun Pharma Global

4/23/2014

Niaspan

Niacin

Abbvie

Sun Pharma Global

4/24/2014

Topicort

Desoximetasone

Taro

Versapharm

4/28/2014

Xylocaine

Glydo

Oak Pharms

Sagent Pharms

4/29/2014

Zutripro

Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride

Cypress Pharm

Paddock

4/29/2014

Rezira

Hydrocodone Bitarate / Pseudoephedrine Hydrochloride

Cypress Pharm

Paddock

5/5/2014

Phentermine Hydrochloride

Phentermine Hydrochloride

Sandoz

Invagen Pharms

5/5/2014

Hectorol

Doxercalciferol

Genzyme

Sandoz

5/6/2014

Catapres-TTS-3

Clonidine

Boehringer Ingelheim

Watson Labs

5/7/2014

Protonix

Pantoprazole Sodium

Wyeth

Perrigo

5/7/2014

Avandamet

Rosiglitazone Maleate / Metformin Hydrochloride

SB Pharmco

Teva

5/8/2014

Dymista

Azelastine Hydrochloride

Media Pharms

Perrigo Israel

5/9/2014

Avalide

Irbesartan / Hydrochlorothiazide

Sanofi Aventis US

Prinston

5/9/2014

Fludeoxyglucose F18

Fludeoxyglucose F-18

Feinstein

UCSF Rodiopharm

5/12/2014

Exalgo

Hydromorphone Hydrochloride

Mallinckrodt

Actavis Labs FL

5/12/2014

Rhinocort

Budesonide

AstraZeneca

Apotex

5/12/2014

Zyprexa Zydis

Olanzapine

Lilly

Mylan Pharms

5/15/2014

Zyprexa Zydis

Olanzapine

Lilly

Aurobindo Pharma

5/19/2014

Focalin XR

Dexmethylphenidate Hydrochloride

Novartis

Teva

5/19/2014

Focalin XR

Dexmethylphenidate Hydrochloride

Novartis

Watson Labs

5/22/2014

Zometa

Zoledronic Acid

Novartis

Akorn

5/27/2014

Pennsaid

Diclofenac Sodium

Mallinckrodt

Apotex

5/27/2014

Yaz

drospirenone / ethinyl estradiol

Bayer Healthcare

Lupin

5/27/2014

Malarone

Atovaquone / Proguanil Hydrochloride

GlaxoSmithKline

Mylan Pharms

5/28/2014

Tobi

Tobramycin

Novartis Pharms

Akorn

5/30/2014

Pepcid

Famotidine

Salix Pharms

Hi-Tech Pharma

5/30/2014

Celebrex

Celecoxib

GD Searle

Mylan Pharms

5/30/2014

Celebrex

Celecoxib

GD Searle

Teva

6/2/2014

Depakote ER

Divalproex Sodium

Abbvie

Aurobindo Pharma

6/2/2014

Ponstel

Mefenamic Acid

Shionogi

Vintage Pharms

6/3/2014

Roxicodone

Oxycodone Hydrochloride

Mallinckrodt

Amneal Pharms

6/3/2014

Mirapex

Pramipexole Dihydrochloride

Boehringer Ingelheim

Strides Arcolab

6/4/2014

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride

Sandoz

Accord Healthcare

6/4/2014

Evoxac

Cevimeline Hydrochloride

Daiichi Sankyo

Pack Pharms

6/5/2014

Oxycodone Hydrochloride

Oxycodone Hydrochloride

Lehigh Valley

Coastal Pharms

6/5/2014

Oxsoralen-Ultra

Methoxsalen

Dow Pharm

Strides Arcolab

6/9/2014

Cymbalta

Duloxetine Hydrochloride

Lilly

Alembic Pharms

6/10/2014

Actonel

Risedronate Sodium

Warner Chilcott

Apotex

6/10/2014

Actonel

Risedronate Sodium

Warner Chilcott

Mylan Pharms

6/10/2014

Lunesta

Eszopiclone

Sunovion Pharms

Orchid Healthcare

6/10/2014

Actonel

Risedronate Sodium

Warner Chilcott

Sun Pharma Global

6/11/2014

Cardura

Doxazosin Mesylate

Pfizer

Accord Healthcare

6/11/2014

Cymbalta

Duloxetine Hydrochloride

Lilly

Apotex

6/11/2014

Cymbalta

Duloxetine Hydrochloride

Lilly

Breckenridge Pharm

6/11/2014

Tarceva

Erlotinib Hydrochloride

OSI Pharms

Mylan Pharms

6/12/2014

Lamictal CD

Lamotrigine

GlaxoSmithKline

Alembic Pharms

6/12/2014

Heparin

Sodium Injection (Preservative Free)

Fresenius Kabi USA/Hikma Maple

Shenzhen Techdow

6/12/2014

Heparin

Sodium Injection (Plastic Container)

Fresenius Kabi USA/Hikma Maple

Shenzhen Techdow

6/12/2014

Heparin

Sodium Injection

Fresenius Kabi USA/Hikma Maple

Shenzhen Techdow

6/13/2014

Codeine Sulfate

Codeine Sulfate

Roxane

Lannett Holdings

6/13/2014

Actonel

Risedronate Sodium

Warner Chilcott

Teva

6/18/2014

Zovirax

Acyclovir

Valeant Bermuda

Amneal Pharms

6/18/2014

Eloxatin/Oxaliplatin

Oxaliplatin

Sanofi Aventis US/Teva

Jiangsu Hengrui Med

6/18/2014

Diuril

Chlorothiazide Sodium

Oak Pharms Akorn

Mylan Institutional

6/19/2014

Bromday

Bromfenac Sodium

Bausch and Lomb

Apotex

6/20/2014

Marinol

Dronabinol

Abbvie

Akorn

6/23/2014

Bromday

Bromfenac Sodium

Bausch and Lomb

Apotex

6/23/2014

Lovenox

Enoxaparin Sodium

Sanofi Aventis US

Teva

6/24/2014

Zemplar

Paricalcitol

Abbvie

Anchen Pharms

6/24/2014

Zemplar

Paricalcitol

Abbvie

Dr Reddy's Labs

6/24/2014

Lovazas

Omega-3-Acid Ethyl Esters

SmithKline Beecham

Par Pharm

6/24/2014

Aldara

Imiquimod

Medicis

Strides Arcolab

6/26/2014

Diovan

Valsartan

Novartis

OHM Labs

6/27/2014

Doxil

Doxorubicin HCl

Janssen Pharms

Actavis

6/27/2014

Opana ER

Oxymorphone HCl

Endo Pharms

Mallinckrodt

6/27/2014

DDAVP

Desmopressin Acetate

Sanofi Aventis

Mylan Pharms

6/27/2014

Suboxone

Buprenorphine HCl / Naloxone HCl

Rickitt Benckiser

Roxane

6/27/2014

Ammonia N-12

Ammonia N-13

Feinstein

University of Texas MD Anderson

6/30/2014

Acova

Argatroban

Pfizer

Mylan Pharms

6/30/2014

Acova

Argatroban

Pfizer

Par Pharm


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