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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
McKinsey
US Army
Cantor Fitzgerald
Citi
Queensland Health
QuintilesIMS
Moodys
Medtronic

Generated: June 24, 2018

DrugPatentWatch Database Preview

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.

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

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Paragraph IV (Patent) Challenges for CONTRAVE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 8 mg/90 mg ➤ Subscribe 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for CONTRAVE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2000 00018 Denmark ➤ Try a Free Trial PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0918 Netherlands ➤ Try a Free Trial 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 ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Medtronic
US Department of Justice
Federal Trade Commission
McKesson
Fish and Richardson
Express Scripts
Baxter
Mallinckrodt

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