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
International Patents: | 257 |
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 |
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 |
Zuyderland Medisch Centrum | Phase 4 |
Nederlandse Obesitas Kliniek | 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
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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