Felbamate - Generic Drug Details
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What are the generic drug sources for felbamate and what is the scope of freedom to operate?
Felbamate
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Novitium Pharma, Taro, Mylan Speciality Lp, Alvogen, Ani Pharms, and Zydus Lifesciences, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for felbamate. Twelve suppliers are listed for this compound.
Summary for felbamate
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 9 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 115 |
Clinical Trials: | 6 |
Patent Applications: | 6,108 |
Drug Prices: | Drug price trends 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 |
Federal University of 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Lifesciences | FELBAMATE | felbamate | TABLET;ORAL | 208970-002 | May 30, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-002 | Jul 29, 1993 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for felbamate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189-003 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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