Bupropion hydrochloride - Generic Drug Details
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What are the generic sources for bupropion hydrochloride and what is the scope of patent protection?
Bupropion hydrochloride
is the generic ingredient in seven branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Adaptis, Anbison Lab, Anchen Pharms, Aurobindo Pharma Usa, Epic Pharma, Granules, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Almatica, Glaxosmithkline, Bausch, Alembic Pharms Ltd, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, and Nalpropion, and is included in sixty-two NDAs. There are twenty 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. Sixty-five suppliers are listed for this compound.
Summary for bupropion hydrochloride
International Patents: | 1 |
US Patents: | 20 |
Tradenames: | 7 |
Applicants: | 37 |
NDAs: | 62 |
Drug Master File Entries: | 30 |
Finished Product Suppliers / Packagers: | 65 |
Raw Ingredient (Bulk) Api Vendors: | 124 |
Clinical Trials: | 370 |
Patent Applications: | 1,685 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for bupropion hydrochloride |
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 |
---|---|
Kenya Medical Research Institute | Phase 4 |
All India Institute of Medical Sciences, Bhubaneswar | Phase 4 |
Valeant Pharmaceuticals International, Inc. | Phase 4 |
Pharmacology for bupropion hydrochloride
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 hydrochloride
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wockhardt Ltd | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202189-001 | Nov 21, 2012 | AB3 | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Invagen Pharms | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 206674-001 | Feb 9, 2016 | AB1 | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Aurobindo Pharma Usa | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090942-002 | Jul 14, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-002 | Oct 4, 1996 | AB1 | RX | Yes | No | 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 |
Expired US Patents for bupropion hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-003 | Oct 4, 1996 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-003 | Oct 4, 1996 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | See Plans and Pricing | See Plans and Pricing |
>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 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bupropion hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2316456 | 2017C/064 | Belgium | See Plans and Pricing | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
2316456 | 349 22-2017 | Slovakia | See Plans and Pricing | 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 |
0656775 | CR 2000 00018 | Denmark | See Plans and Pricing | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
0656775 | 28/2000 | Austria | See Plans and Pricing | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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