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Last Updated: August 5, 2020

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FLURAZEPAM HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for flurazepam hydrochloride and what is the scope of freedom to operate?

Flurazepam hydrochloride is the generic ingredient in two branded drugs marketed by Valeant Pharm Intl, 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-three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for flurazepam hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for FLURAZEPAM HYDROCHLORIDE

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

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

See all FLURAZEPAM HYDROCHLORIDE clinical trials

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
Purepac Pharm FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071927-001 Sep 9, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070454-001 Aug 4, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Usl Pharma FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070562-001 Jul 9, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Valeant Pharm Intl DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Usl Pharma FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070563-001 Jul 9, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070445-001 Mar 20, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Superpharm FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071659-001 Aug 4, 1988 DISCN No No   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 FLURAZEPAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Valeant Pharm Intl DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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