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Last Updated: August 10, 2020

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FELBATOL Drug Profile

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Which patents cover Felbatol, and when can generic versions of Felbatol launch?

Felbatol is a drug marketed by Mylan Speciality Lp and is included in one NDA.

The generic ingredient in FELBATOL is felbamate. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the felbamate profile page.

US ANDA Litigation and Generic Entry Outlook for Felbatol

A generic version of FELBATOL was approved as felbamate by AMNEAL PHARMS on September 13th, 2011.

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Drug patent expirations by year for FELBATOL
Drug Prices for FELBATOL

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Recent Clinical Trials for FELBATOL

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SponsorPhase
National Institute of Mental Health (NIMH)Phase 2

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US Patents and Regulatory Information for FELBATOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-001 Jul 29, 1993 AB RX Yes No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-002 Jul 29, 1993 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 FELBATOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-002 Jul 29, 1993   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-001 Jul 29, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
McKesson
Express Scripts
Medtronic
AstraZeneca

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