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 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-two 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 seventy-two patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
International Patents: | 272 |
US Patents: | 22 |
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
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
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. | ⤷ Sign Up |
European Patent Office | 3659604 | MÉTHODES D'AMAIGRISSEMENTU POUR DES PATIENTS SOUFFRANT D'UNE DÉPRESSION SÉVÈRE (METHODS OF PROVIDING WEIGHT LOSS THERAPY IN PATIENTS WITH MAJOR DEPRESSION) | ⤷ Sign Up |
Denmark | 1617832 | ⤷ Sign Up | |
>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 | C201730057 | Spain | ⤷ Sign Up | PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326 |
2316456 | 132017000142109 | Italy | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
2316456 | 349 22-2017 | Slovakia | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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