Bupropion hydrochloride - Generic Drug Details
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What are the generic drug sources for bupropion hydrochloride and what is the scope of patent protection?
Bupropion hydrochloride
is the generic ingredient in eight branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Anchen Pharms, Annora Pharma, Aurobindo Pharma Usa, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sciegen Pharms Inc, Scinopharm Taiwan, Sinotherapeutics Inc, Sun Pharm, Torrent, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Twi Pharms, Glaxosmithkline, Bausch, Alembic, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, Axsome, and Nalpropion, and is included in sixty-five NDAs. There are one hundred and thirty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Bupropion hydrochloride has one patent family member in one country.
There are thirty drug master file entries for bupropion hydrochloride. Seventy-five suppliers are listed for this compound.
Summary for bupropion hydrochloride
International Patents: | 1 |
US Patents: | 133 |
Tradenames: | 8 |
Applicants: | 38 |
NDAs: | 65 |
Drug Master File Entries: | 30 |
Finished Product Suppliers / Packagers: | 75 |
Raw Ingredient (Bulk) Api Vendors: | 137 |
Clinical Trials: | 377 |
Patent Applications: | 1,710 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in bupropion hydrochloride? | bupropion hydrochloride excipients list |
DailyMed Link: | bupropion hydrochloride at DailyMed |
Recent Clinical Trials for bupropion hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mclean Hospital | Phase 4 |
Kenya Medical Research Institute | Phase 4 |
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude | Phase 2 |
Pharmacology for bupropion hydrochloride
Drug Class | Aminoketone |
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FORFIVO XL | Extended-release Tablets | bupropion hydrochloride | 450 mg | 022497 | 1 | 2013-02-28 |
WELLBUTRIN XL | Extended-release Tablets | bupropion hydrochloride | 150 mg and 300 mg | 021515 | 1 | 2004-09-21 |
US Patents and Regulatory Information for bupropion hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zhejiang Jutai Pharm | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211200-001 | Sep 5, 2019 | AB3 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Graviti Pharms | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211020-001 | Jan 28, 2019 | AB3 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-004 | Jun 14, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | WELLBUTRIN XL | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021515-002 | Aug 28, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for bupropion hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2008038155 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bupropion hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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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