BACLOFEN Drug Patent Profile
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Which patents cover Baclofen, and when can generic versions of Baclofen launch?
Baclofen is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Ani Pharms, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Endo Operations, Eywa, Graviti Pharms, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Norvium Bioscience, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Watson Labs, and Zydus Lifesciences. and is included in forty-one NDAs.
The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Baclofen
A generic version of BACLOFEN was approved as baclofen by IVAX SUB TEVA PHARMS on July 21st, 1988.
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Questions you can ask:
- What is the 5 year forecast for BACLOFEN?
- What are the global sales for BACLOFEN?
- What is Average Wholesale Price for BACLOFEN?
Summary for BACLOFEN
| US Patents: | 0 |
| Applicants: | 29 |
| NDAs: | 41 |
| Finished Product Suppliers / Packagers: | 55 |
| Raw Ingredient (Bulk) Api Vendors: | 149 |
| Clinical Trials: | 126 |
| Patent Applications: | 3,924 |
| Drug Prices: | Drug price information for BACLOFEN |
| Drug Sales Revenues: | Drug sales revenues for BACLOFEN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BACLOFEN |
| What excipients (inactive ingredients) are in BACLOFEN? | BACLOFEN excipients list |
| DailyMed Link: | BACLOFEN at DailyMed |
Recent Clinical Trials for BACLOFEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospices Civils de Lyon | Phase 2/Phase 3 |
| University of Louisville | Phase 2 |
| Institute of Liver and Biliary Sciences, India | N/A |
Pharmacology for BACLOFEN
| Drug Class | gamma-Aminobutyric Acid-ergic Agonist |
| Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for BACLOFEN
Anatomical Therapeutic Chemical (ATC) Classes for BACLOFEN
US Patents and Regulatory Information for BACLOFEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | BACLOFEN | baclofen | TABLET;ORAL | 072824-001 | Sep 18, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lannett Co Inc | BACLOFEN | baclofen | TABLET;ORAL | 077241-001 | Dec 20, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Graviti Pharms | BACLOFEN | baclofen | TABLET;ORAL | 217788-001 | Jan 10, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Northstar Hlthcare | BACLOFEN | baclofen | TABLET;ORAL | 078401-001 | Sep 18, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rubicon | BACLOFEN | baclofen | TABLET;ORAL | 209102-003 | Nov 28, 2017 | AB | RX | 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 |
