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CONTRAVE Drug Profile

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Which patents cover Contrave, and what generic alternatives are available?

Contrave is a drug marketed by Nalpropion and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-five patent family members in thirty-three countries.

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

US ANDA Litigation and Generic Entry Outlook for Contrave

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 20, 2024. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CONTRAVE

International Patents:	175
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	1
Clinical Trials:	10
Patent Applications:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CONTRAVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONTRAVE
DailyMed Link:	CONTRAVE at DailyMed

See drug prices for CONTRAVE

Generic Entry Opportunity Date for CONTRAVE

NDA:

200063

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CONTRAVE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Nebraska	Phase 4
Lindner Center of HOPE	Phase 2
Yale University	Phase 2/Phase 3

See all CONTRAVE clinical trials

Recent Litigation for CONTRAVE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Orexigen Therapeutics, Inc. v. Actavis Laboratories FL, Inc..	2015-06-03

See all CONTRAVE litigation

Pharmacology for CONTRAVE

Drug Class	Opioid Antagonist Aminoketone
Mechanism of Action	Opioid Antagonists Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Synonyms for CONTRAVE

1201668-08-7

Bupropion / naltrexone

Bupropion mixture with naltrexone

Mysimba

Naltrexone / bupropion

Naltrexone/bupropion

SCHEMBL15633271

Paragraph IV (Patent) Challenges for CONTRAVE

Tradename	Dosage	Ingredient	NDA	Submissiondate
CONTRAVE	TABLET, EXTENDED RELEASE;ORAL	bupropion hydrochloride; naltrexone hydrochloride	200063	2015-03-12

US Patents and Regulatory Information for CONTRAVE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes			Y
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes

International Patents for CONTRAVE

Country	Patent Number	Estimated Expiration
Mexico	2009004874
Japan	5980840
Argentina	063958
Denmark	1617832
European Patent Office	2523557
World Intellectual Property Organization (WIPO)	2004096201

Supplementary Protection Certificates for CONTRAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	LUC00054	Luxembourg		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0656775	CR 2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	1790064-8	Sweden		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
2316456	65/2017	Austria		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330
2316456	C20170044 00252	Estonia		PRODUCT NAME: NALTREKSOON/BUPROPIOON;REG NO/DATE: EU/1/14/988 30.03.2015