FELBAMATE Drug Patent Profile
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Which patents cover Felbamate, and when can generic versions of Felbamate launch?
Felbamate is a drug marketed by Amneal Pharms, Novitium Pharma, Taro, Alvogen, Ani Pharms, and Zydus Lifesciences. and is included in eight NDAs.
The generic ingredient in FELBAMATE is felbamate. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the felbamate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Felbamate
A generic version of FELBAMATE was approved as felbamate by AMNEAL PHARMS on September 13th, 2011.
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Questions you can ask:
- What is the 5 year forecast for FELBAMATE?
- What are the global sales for FELBAMATE?
- What is Average Wholesale Price for FELBAMATE?
Summary for FELBAMATE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,141 |
| Drug Prices: | Drug price information for FELBAMATE |
| What excipients (inactive ingredients) are in FELBAMATE? | FELBAMATE excipients list |
| DailyMed Link: | FELBAMATE at DailyMed |
Recent Clinical Trials for FELBAMATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Grossman, S.A. | Phase 3 |
| Instituto Nacional de Salud Publica, Mexico | Phase 3 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Pharmacology for FELBAMATE
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for FELBAMATE
US Patents and Regulatory Information for FELBAMATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | FELBAMATE | felbamate | SUSPENSION;ORAL | 202385-001 | Dec 16, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms | FELBAMATE | felbamate | TABLET;ORAL | 201680-002 | Sep 13, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alvogen | FELBAMATE | felbamate | TABLET;ORAL | 204595-001 | Jan 11, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Lifesciences | FELBAMATE | felbamate | TABLET;ORAL | 208970-001 | May 30, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | FELBAMATE | felbamate | TABLET;ORAL | 202284-001 | Nov 4, 2015 | 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 |
