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Last Updated: March 26, 2023

Bupropion hydrochloride; naltrexone hydrochloride - Generic Drug Details


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What are the generic sources for bupropion hydrochloride; naltrexone hydrochloride and what is the scope of patent protection?

Bupropion hydrochloride; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Nalpropion and is included in one NDA. There are twenty 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 two hundred and fifty-seven patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; naltrexone hydrochloride
Recent Clinical Trials for bupropion hydrochloride; naltrexone hydrochloride

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SponsorPhase
University of California, Los AngelesEarly Phase 1
Zuyderland Medisch CentrumPhase 4
Nederlandse Obesitas KliniekPhase 4

See all bupropion hydrochloride; naltrexone hydrochloride clinical trials

Pharmacology for bupropion hydrochloride; naltrexone hydrochloride
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
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 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
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for bupropion hydrochloride; naltrexone hydrochloride

Country Patent Number Title Estimated Expiration
Cyprus 1119418 See Plans and Pricing
Australia 2004233846 Compositions for affecting weight loss See Plans and Pricing
Australia 2007319472 Unit dosage package and methods for administering weight loss medications See Plans and Pricing
Japan 2020037593 主要有害心血管事象を低減するための組成物及び方法 (COMPOSITIONS AND METHODS FOR REDUCING MAJOR ADVERSE CARDIOVASCULAR EVENTS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bupropion hydrochloride; naltrexone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 132017000142109 Italy See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 2017C/064 Belgium See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0467488 SPC/GB00/019 United Kingdom See Plans and Pricing PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456 C20170044 00252 Estonia See Plans and Pricing PRODUCT NAME: NALTREKSOON/BUPROPIOON;REG NO/DATE: EU/1/14/988 30.03.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.