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 nineteen 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 forty-five patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for bupropion hydrochloride; naltrexone hydrochloride
International Patents: | 245 |
US Patents: | 19 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 47 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for bupropion hydrochloride; naltrexone hydrochloride |
DailyMed Link: | bupropion hydrochloride; naltrexone hydrochloride at DailyMed |
Recent Clinical Trials for bupropion hydrochloride; naltrexone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Currax Pharmaceuticals | Phase 4 |
University of California, Los Angeles | Early Phase 1 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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
Expired US Patents for bupropion hydrochloride; naltrexone hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | 7,462,626 | ⤷ Try for Free |
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | 8,815,889 | ⤷ Try for Free |
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | 11,278,544 | ⤷ Try for Free |
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | 7,375,111 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for bupropion hydrochloride; naltrexone hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6240140 | ⤷ Try for Free | |
Japan | 6665094 | ⤷ Try for Free | |
South Korea | 102472432 | ⤷ Try for Free | |
Brazil | 112016012755 | USO DE 4 A 50 MG DE NALTREXONA DE LIBERAÇÃO SUSTENTADA, OU UM SAL FARMACEUTICAMENTE ACEITÁVEL DA MESMA E 50 A 400MG DE BUPROPIONA, OU UM SAL FARMACEUTICAMENTE ACEITÁVEL DA MESMA | ⤷ Try for Free |
Taiwan | 200808319 | Sustained release formulation of naltrexone | ⤷ Try for Free |
Eurasian Patent Organization | 201492175 | СПОСОБЫ ЛЕЧЕНИЯ ИЗБЫТОЧНОГО ВЕСА И ОЖИРЕНИЯ | ⤷ Try for Free |
Japan | 2014005310 | SUSTAINED RELEASE FORMULATION OF NALTREXONE | ⤷ Try for Free |
>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 |
---|---|---|---|---|
0656775 | 28/2000 | Austria | ⤷ Try for Free | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
2316456 | CR 2017 00062 | Denmark | ⤷ Try for Free | 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 | 657 | Finland | ⤷ Try for Free | |
2316456 | 122017000109 | Germany | ⤷ Try for Free | 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 |
2316456 | 2017C/064 | Belgium | ⤷ Try for Free | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
2316456 | 349 22-2017 | Slovakia | ⤷ Try for Free | PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
2316456 | 132017000142109 | Italy | ⤷ Try for Free | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for the Drug: Bupropion Hydrochloride; Naltrexone Hydrochloride (Contrave)
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