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
International Patents: | 269 |
US Patents: | 20 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 46 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE |
DailyMed Link: | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE at DailyMed |
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
Sponsor | Phase |
---|---|
University of California, Los Angeles | Early Phase 1 |
Nederlandse Obesitas Kliniek | Phase 4 |
Zuyderland Medisch Centrum | Phase 4 |
See all BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE clinical trials
Pharmacology for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Class | Aminoketone Opioid Antagonist |
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Opioid Antagonists |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
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
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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