FELBAMATE - Generic Drug Details

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What are the generic 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

See drug prices for FELBAMATE

Recent Clinical Trials for FELBAMATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Instituto Nacional de Salud Publica, Mexico	Phase 3
Laboratorios Grossman, S.A.	Phase 3
Federal University of São Paulo	Phase 4

See all FELBAMATE clinical trials

Pharmacology for FELBAMATE

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for FELBAMATE

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for FELBAMATE

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Glossary

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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
Taro	FELBAMATE	felbamate	TABLET;ORAL	207093-001	Apr 20, 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

Expired US Patents for FELBAMATE

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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
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-002	Jul 29, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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