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Last Updated: July 14, 2020

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FLURAZEPAM HYDROCHLORIDE Drug Profile


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When do Flurazepam Hydrochloride patents expire, and what generic alternatives are available?

Flurazepam Hydrochloride is a drug marketed by Aurolife Pharma Llc, Halsey, Heritage Pharma, Hikma Intl Pharms, Hikma Pharms, Mylan Pharms Inc, Par Pharm, Purepac Pharm, Sun Pharm Industries, Superpharm, Usl Pharma, and Warner Chilcott. and is included in twenty-two NDAs.

The generic ingredient in FLURAZEPAM HYDROCHLORIDE is flurazepam hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Flurazepam Hydrochloride

A generic version of FLURAZEPAM HYDROCHLORIDE was approved as flurazepam hydrochloride by MYLAN PHARMS INC on November 27th, 1985.

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Drug patent expirations by year for FLURAZEPAM HYDROCHLORIDE
Recent Clinical Trials for FLURAZEPAM HYDROCHLORIDE

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SponsorPhase
Saint-Joseph UniversityPhase 3
Eisai Inc.Phase 1
Hannover Medical SchoolPhase 3

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Pharmacology for FLURAZEPAM HYDROCHLORIDE
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for FLURAZEPAM HYDROCHLORIDE

US Patents and Regulatory Information for FLURAZEPAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurolife Pharma Llc FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071717-002 Jul 31, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070455-001 Aug 4, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Warner Chilcott FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071768-001 Dec 4, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071068-001 Nov 25, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Halsey FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071809-001 Jan 7, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070345-001 Nov 27, 1985 RX No 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Medtronic
Dow
McKesson
Harvard Business School

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