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Last Updated: March 28, 2024

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 sixty-nine patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Generic Entry Date for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, Los AngelesEarly Phase 1
Nederlandse Obesitas KliniekPhase 4
Zuyderland Medisch CentrumPhase 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Hungary E034290 ⤷  Try a Trial
South Korea 102472432 ⤷  Try a Trial
Chile 2014003329 Un metodo para el tratamiento del sobrepeso o la obesidad, en un sujeto que corre un riesgo mayor de sufrir un resultado cardiovascular adverso, que comprende identificar a un sujeto obeso o con sobrepeso y administrar naltrexona de liberacion sostenida o una de sus sales y bupropion de liberacion sostenida o una de sus sales. ⤷  Try a Trial
Netherlands 300918 ⤷  Try a Trial
Spain 2760464 ⤷  Try a Trial
>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 657 Finland ⤷  Try a Trial
2316456 122017000109 Germany ⤷  Try a Trial 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
0656775 CR 2000 00018 Denmark ⤷  Try a Trial PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2316456 CA 2017 00062 Denmark ⤷  Try a 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
2316456 300918 Netherlands ⤷  Try a 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
>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.