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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cerilliant
Merck
McKinsey
US Department of Justice
Baxter
Chubb
Medtronic
Colorcon

Generated: April 26, 2018

DrugPatentWatch Database Preview

Bupropion hydrochloride; naltrexone hydrochloride - Generic Drug Details

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What are the generic drug sources for bupropion hydrochloride; naltrexone hydrochloride and what is the scope of bupropion hydrochloride; naltrexone hydrochloride freedom to operate?

Bupropion hydrochloride; naltrexone hydrochloride
is the generic ingredient in one branded drug marketed by Orexigen and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; naltrexone hydrochloride has one hundred and thirty-seven patent family members in twenty-four countries.

There are thirty-eight drug master file entries for bupropion hydrochloride; naltrexone hydrochloride. Three suppliers are listed for this compound.
Summary for bupropion hydrochloride; naltrexone hydrochloride
Pharmacology for bupropion hydrochloride; naltrexone hydrochloride

US Patents and Regulatory Information for bupropion hydrochloride; naltrexone hydrochloride

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orexigen CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orexigen CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Orexigen CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Non-Orange Book US Patents for bupropion hydrochloride; naltrexone hydrochloride

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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for bupropion hydrochloride; naltrexone hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0918 Netherlands ➤ Sign Up 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
/2000 Austria ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2017000109 Germany ➤ Sign Up PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2017 00062 Denmark ➤ Sign Up 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:

Covington
Harvard Business School
Express Scripts
Mallinckrodt
AstraZeneca
US Army
Queensland Health
Medtronic
Fish and Richardson

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 verifification 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.