Details for New Drug Application (NDA): 200063

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NDA 200063 describes CONTRAVE, which is a drug marketed by Nalpropion and is included in one NDA. It is available from one supplier. There are twenty-two 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-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.

Summary for 200063

Tradename:	CONTRAVE
Applicant:	Nalpropion
Ingredient:	bupropion hydrochloride; naltrexone hydrochloride
Patents:	22

Pharmacology for NDA: 200063

Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Opioid Antagonists
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

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	Nalpropion Pharmaceuticals LLC	51267-890	51267-890-07	7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07)
CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063	NDA	Nalpropion Pharmaceuticals LLC	51267-890	51267-890-99	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	90MG;8MG
Approval Date:	Sep 10, 2014	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 2, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Patent:	⤷ Sign Up	Patent Expiration:	Nov 8, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
Patent:	⤷ Sign Up	Patent Expiration:	Jun 5, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Expired US Patents for NDA 200063

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	⤷ Sign Up	⤷ Sign Up
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	⤷ Sign Up	⤷ Sign Up
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.