CONTRAVE Drug Patent Profile

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 nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-seven patent family members in forty-one 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.

DrugPatentWatch^® Generic Entry Outlook for Contrave

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 21, 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:	237
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	19
Patent Applications:	258
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CONTRAVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONTRAVE
What excipients (inactive ingredients) are in CONTRAVE?	CONTRAVE excipients list
DailyMed Link:	CONTRAVE at DailyMed

See drug prices for CONTRAVE

DrugPatentWatch^® Estimated 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 California, Los Angeles	Early Phase 1
Zuyderland Medisch Centrum	Phase 4
Nederlandse Obesitas Kliniek	Phase 4

See all CONTRAVE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CONTRAVE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for CONTRAVE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CONTRAVE	Extended-release Tablets	bupropion hydrochloride; naltrexone hydrochloride	8 mg/90 mg	200063	1	2015-03-12

US Patents and Regulatory Information for CONTRAVE

CONTRAVE is protected by nineteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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			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
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

When does loss-of-exclusivity occur for CONTRAVE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Hungary

Israel

Japan

Luxembourg

Mexico

Netherlands

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CONTRAVE around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2711638	КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ УМЕНЬШЕНИЯ СЕРЬЕЗНЫХ НЕБЛАГОПРИЯТНЫХ СЕРДЕЧНО-СОСУДИСТЫХ ЯВЛЕНИЙ (COMPOSITIONS AND METHODS FOR REDUCING SERIOUS ADVERSE CARDIOVASCULAR EVENTS)
Japan	5980840
Japan	2014005310	SUSTAINED RELEASE FORMULATION OF NALTREXONE
Japan	2009516744
European Patent Office	1870096	Compositions pour influencer la perte de poids (Compositions for affecting weight loss)
Canada	2785822	METHODES PERMETTANT DE FAIRE PERDRE DU POIDS A DES PATIENTS SOUFFRANT D'UNE DEPRESSION SEVERE (METHODS OF PROVIDING WEIGHT LOSS THERAPY IN PATIENTS WITH MAJOR DEPRESSION)

Supplementary Protection Certificates for CONTRAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330