BUPROPION HYDROCHLORIDE Drug Patent Profile
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Which patents cover Bupropion Hydrochloride, and what generic alternatives are available?
Bupropion Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Endo Operations, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Prinston Inc, Rising, Sandoz, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alembic, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, and Micro Labs. and is included in fifty-eight NDAs.
The generic ingredient in BUPROPION HYDROCHLORIDE is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bupropion Hydrochloride
A generic version of BUPROPION HYDROCHLORIDE was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7th, 2000.
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Questions you can ask:
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Summary for BUPROPION HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 33 |
| NDAs: | 58 |
| Finished Product Suppliers / Packagers: | 72 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 381 |
| Patent Applications: | 1,189 |
| 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 |
|---|---|
| Currax Pharmaceuticals | Phase 4 |
| Virginia Commonwealth University | Phase 1/Phase 2 |
| Mclean Hospital | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203650-001 | Dec 31, 2020 | AB3 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apnar Pharma Lp | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 075584-002 | Feb 7, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Invagen Pharms | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 206674-003 | Feb 9, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075913-001 | Jan 28, 2004 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wockhardt Ltd | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201331-003 | Aug 30, 2012 | DISCN | No | No | ⤷ 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 |
