Bupropion hydrobromide - Generic Drug Details
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What are the generic sources for bupropion hydrobromide and what is the scope of patent protection?
Bupropion hydrobromide
is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Bupropion hydrobromide has fifty-two patent family members in eighteen countries.
There are five drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for bupropion hydrobromide
International Patents: | 52 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 20 |
Clinical Trials: | 3 |
What excipients (inactive ingredients) are in bupropion hydrobromide? | bupropion hydrobromide excipients list |
DailyMed Link: | bupropion hydrobromide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrobromide
Generic Entry Date for bupropion hydrobromide*:
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 hydrobromide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bausch Health Americas, Inc. | Phase 4 |
Valeant Pharmaceuticals International, Inc. | Phase 4 |
Alphacait, LLC | Phase 2 |
Generic filers with tentative approvals for BUPROPION HYDROBROMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 522MG | TABLET, EXTENDED RELEASE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 174MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for bupropion hydrobromide
Drug Class | Aminoketone |
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrobromide
Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
APLENZIN | Extended-release Tablets | bupropion hydrobromide | 522 mg | 022108 | 1 | 2009-12-24 |
APLENZIN | Extended-release Tablets | bupropion hydrobromide | 174 mg | 022108 | 1 | 2009-09-28 |
APLENZIN | Extended-release Tablets | bupropion hydrobromide | 348 mg | 022108 | 1 | 2009-09-24 |
US Patents and Regulatory Information for bupropion hydrobromide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 hydrobromide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Colombia | 6251360 | BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS | ⤷ Sign Up |
Japan | 2011500865 | ⤷ Sign Up | |
South Korea | 20100055402 | BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bupropion hydrobromide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2316456 | 2017/059 | Ireland | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
2316456 | 132017000142109 | Italy | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
2316456 | CR 2017 00062 | Denmark | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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