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CONTRAVE Drug Profile

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Which patents cover Contrave, and when can generic versions of Contrave launch?

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

This drug has one hundred and thirty-seven patent family members in twenty-four 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.

Summary for CONTRAVE

International Patents:	137
US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	1
Clinical Trials:	7
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONTRAVE
DailyMed Link:	CONTRAVE at DailyMed

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

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
Orexigen	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Orexigen	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Orexigen	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Orexigen	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes

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Paragraph IV (Patent) Challenges for CONTRAVE

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Tablets	8 mg/90 mg		2015-03-12

Non-Orange Book US Patents for CONTRAVE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,457,005	Compositions and methods for increasing insulin sensitivity

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International Patents for CONTRAVE

Country	Document Number	Estimated Expiration
China	101370488
Taiwan	200829235
China	1784221
Denmark	1617832

Supplementary Protection Certificates for CONTRAVE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0918	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
2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330