Generic Launches Q3 2012

Reference Listed Drug

NDA Holder

Generic Drug Name

ANDA Applicant(s)

Indication

Launch Date

Boniva

GlaxoSmithKline/Roche

ibandronate sodium tablets

Dr. Reddy's Labs

Osteoporosis

July 2, 2012

Lescol

Novartis

fluvastatin capsules, USP

Teva

Antilipemic/statins

Jul. 2, 2012

Clarinex

Schering-Plough

desloratadine tablets

Mylan

Allergy medication

July 3, 2012

Lithobid Tablets

Noven Therapeutic

lithobid carbonate extended release tablets USP

Mylan

Bipolar disorder

Jul. 3, 2012

Plan B One-Step

Teva

levonorgestrel tablets

Watson Labs

Prevention of pregnancy

Jul. 13, 2012

Ritalin LA Extended Release Capsules

Novartis

methylphenidate hydrochloride extended release capsules

Teva

ADHD

July 16, 2012

Lipitor

Pfizer

atorvastatin calcium tabs

Dr. Reddy's Labs

High cholesterol

Jul. 18, 2012

Oxacillin Sodium ADD-Vantage

Sandoz

oxacillin for injection

Sagent Pharm

Antibiotic

Jul. 24, 2012

Sporanox

Janssen Pharmaceutical

itraconazole capsules

Mylan

Fungal infections in the lungs, blastomycosis, histoplasmosis and aspergillosis

Jul. 27, 2012

Oxycodone

Lehigh Valley

oxycodone hydrochloride

Coastal Pharmaceuticals

Pain management

Jul. 30, 2012

Methotrexate sodium

Quad Pharms

methotrexate injection

Teva

Antineoplastics

Jul. 31, 2012

Dovonex

LEO Pharma

calcipotriene cream

Sandoz

Plaque psoriasis

Aug. 3, 2012

Singulair Tablets and Singulair Chewable Tablets

Merck

montelukast sodium tablets and montelukast sodium chewable tablets

Roxane

Asthma and allergies

Aug. 3, 2012

Singulair Tablets and Singulair Chewable Tablets

Merck

montelukast sodium tablets and montelukast sodium chewable tablets

Teva

Asthma and allergies

Aug. 3, 2012

Amidate Injection

Hospira

etomidate injection USP

Mylan

Induction of general anesthesia

Aug. 6, 2012

Singulair Tablets and Singulair Chewable Tablets

Merck

montelukast sodium tablets and montelukast sodium chewable tablets

Sandoz

Asthma and allergies

Aug. 6, 2012

Singulair Tablets and Singulair Chewable Tablets

Merck

montelukast sodium tablets and montelukast sodium chewable tablets

Endo Pharmaceuticals

Asthma and allergies

Aug. 6, 2012

Singulair Tablets and Singulair Chewable Tablets

Merck

montelukast sodium tablets and montelukast sodium chewable tablets

Glenmark Generics

Asthma and allergies

Aug. 6, 2012

Singulair Tablets and Singulair Chewable Tablets

Merck

montelukast sodium tablets and montelukast sodium chewable tablets

Mylan

Asthma and allergies

Aug. 7, 2012

Singulair Tablets and Singulair Chewable Tablets

Merck

montelukast sodium tablets and montelukast sodium chewable tablets

Dr. Reddy's Labs

Asthma and allergies

Aug. 7, 2012

Morphine Sulfate

Roxane

morphine sulfate

Perrigo

Opioid analgesic for pain management

Aug. 8, 2012

Clobex Shampoo

Galderma Labs

clobetasol propionate shampoo

Perrigo

Scalp psoriasis

Aug, 9, 2012

Elaxotin

Sanofi Aventis

oxaliplatin for injection

Hospira

Chemotherapy

Aug. 9, 2012

Eloxatin

Sanofi Aventis

oxaliplatin for injection

Sagent Pharm

Stage II colon cancer

Aug. 9, 2012

Lithium Carbonate

Roxane

lithium carbonate extended release tablets USP

Mylan

Manic episodes of manic depressive illness

Aug. 10, 2012

Provigil Tablets

Cephalon

modafinil tablets USP

Mylan

Improve wakefulness

Aug. 10, 2012

Eloxatin

Sanofi Aventis

oxaliplatin injection

Teva

Antineoplastics

Aug. 13, 2012

Uroxatral

Sanofi Aventis

alfuzosin hydrochloride

Wockhardt

Benign prostatic hyperplasia and enlarged prostate

Aug. 14, 2012

Plavix

Bristol-Myers Squibb

clopidogrel bisulfate

Wockhardt

Clot-buster

Aug. 16, 2012

Actoplus Met Tablets

Takeda Pharmaceutical Company

pioglitazone hydrochloride and metformin hydrochloride

Mylan

Anti-diabetic

Aug. 17, 2012

Actos

Takeda Pharmaceutical Company

pioglitazone hydrochloride tablet

Teva

Anti-diabetic

Aug. 17, 2012

Actos

Takeda Pharmaceutical Company

pioglitazone hydrochloride tablet

Ranbaxy

Anti-diabetic

Aug. 17, 2012

Actos Tablets

Takeda Pharmaceutical Company

pioglitazone hydrochloride tablet

Mylan

Anti-diabetic

Aug. 17, 2012

Actosplus Met

Takeda Pharmaceutical Company

pioglitazone hydrochloride and metformin hydrochloride

Teva

Anti-diabetic

Aug. 17, 2012

Xopenex

Sunovion Pharmaceuticals

levalbuterol hydrochloride inhalation solution

Watson Labs

Bronchospasm

Aug. 20, 2012

Xopenex

Sunovion Pharmaceuticals

levalbuterol hydrochloride inhalation solution

Prasco

Bronchospasm

Aug. 20, 2012

Plendil

AstraZeneca

felodipine

Wockhardt

Anti-hypertension

Aug. 21, 2012

FazaClo

Jazz Pharmaceuticals

clozapine tablets

Teva

Anti-psychotic

Aug. 29, 2012

Wellbutrin

GlaxoSmithKline

bupropion hydrochloride

Wockhardt

Anti-depressant

Sept. 3, 2012

Zofran

Glaxo Group Limited Corporation

ondansetron for injection

Sagent Pharm

Antiemetic for emetogenic cancer chemotherapy

Sept. 10, 2012

Toprol-XL

AstraZeneca

metoprolol succinate

Dr. Reddy's Labs

Angina and hypertension

Sept. 11, 2012

Prevacid

Takeda

lansoprazole

Wockhardt

anti-ulcer

Sept. 17, 2012

Amoxil

GlaxoSmithKline

amoxicillin tablets

Dr. Reddy's Labs

Antibiotic

Sept. 20, 2012

Antivert Tablets

Pfizer

meclizine hydrochloride tablets USP

Mylan

Nausea and vomiting, and dizziness associated with motion sickness

Sept. 21, 2012

Diovan and Diovan HCT

Novartis

valsartan and hydrochlorothiazide tablets

Sandoz

High blood pressure

Sept. 21, 2012

Coumadin

Bristol-Myers Squibb

warfarin sodium tablets

InvaGen

Venous thrombosis

Sept. 26, 2011

Metedete CD/Ritalin LA

UCB/Novartis

methylphenidate hydrochloride extended release capsules

Teva

ADHD

Sept. 27, 2012

Avapro and Avalide

Sanofi Aventis

irbesartan tablets USP and hydrochlorothiazide tablets USP

Mylan

Hypertension

Sept. 28, 2012

Vancocin

Quad Pharms

vancomycin hydrochloride for injection

Sagent Pharm

Antibiotic

Sept. 28, 2012