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Serving leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Healthtrust
McKesson
Mallinckrodt
Julphar
Baxter
Fish and Richardson
Federal Trade Commission
Boehringer Ingelheim

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200063

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NDA 200063 describes CONTRAVE, which is a drug marketed by Orexigen and is included in one NDA. It is available from four suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CONTRAVE profile page.

The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.

Summary for NDA: 200063

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:10
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 200063

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CONTRAVE
bupropion hydrochloride; naltrexone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200063 NDA PD-Rx Pharmaceuticals, Inc. 43063-772 43063-772-70 70 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-772-70)
CONTRAVE
bupropion hydrochloride; naltrexone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200063 NDA A-S Medication Solutions 50090-2868 50090-2868-0 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2868-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG;8MG
Approval Date:Sep 10, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 10, 2017
Regulatory Exclusivity Use:NEW COMBINATION
Patent:► SubscribePatent Expiration:Mar 26, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jul 20, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY


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Serving leading biopharmaceutical companies globally:

Merck
Argus Health
Mallinckrodt
Dow
Baxter
Cipla
McKesson
Harvard Business School
Moodys
Fuji

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