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Serving leading biopharmaceutical companies globally:

Express Scripts
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McKinsey
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Generated: December 12, 2017

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 patent family members in twenty-one countries and three supplementary protection certificates in three countries.

There are thirty-seven 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,457,005Compositions and methods for increasing insulin sensitivity► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bupropion hydrochloride; naltrexone hydrochloride

Country Document Number Estimated Expiration
South Korea101735466► Subscribe
Portugal2316456► Subscribe
Argentina063959► Subscribe
Mexico344303► Subscribe
European Patent Office1617832► Subscribe
Japan5478245► Subscribe
Japan2013516493► Subscribe
South Korea20150046390► Subscribe
Japan2013047272► Subscribe
Australia2004233846► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
C/GB00/019United Kingdom► SubscribePRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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Serving leading biopharmaceutical companies globally:

UBS
Farmers Insurance
Teva
Cantor Fitzgerald
Merck
Harvard Business School
QuintilesIMS
Medtronic
McKesson
Accenture

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.

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