Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 5, 2019

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Flurazepam hydrochloride - Generic Drug Details

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What are the generic 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

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

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Recent Litigation for flurazepam hydrochloride

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District Court Litigation
Case NameDate
Tyco Healthcare Group v. Mutual Pharmaceutical Co2013-05-06

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Pharmacology for flurazepam hydrochloride
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for flurazepam hydrochloride
Synonyms for flurazepam hydrochloride
1172-18-5
17617-23-1 (Parent)
2H-1,4-Benzodiazepin-2-one, 7-chloro-1-(2-(diethylamino)ethyl)-5-(2-fluorophenyl)-1,3-dihydro-, dihydrochloride
2H-1,4-Benzodiazepin-2-one, 7-chloro-1-(2-(diethylamino)ethyl)-5-(o-fluorophenyl)-, 1,3-dihydro-, dihydrochloride
2H-1,4-Benzodiazepin-2-one, 7-chloro-1-(2-(diethylamino)ethyl)-5-(o-fluorophenyl)-,1,3-dihydro-, dihydrochloride
7-chloro-1-(2-(diethylamino)ethyl)-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one, dihydrochloride
7-Chloro-1-(2-(diethylamino)ethyl)-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one dihydrochloride
7-chloro-1-(2-diethylaminoethyl)-5-(2-fluorophenyl)-3H-1,4-benzodiazepin-2-one dihydrochloride
7-Chloro-1-(diethylamino)ethyl-5-(2-fluorophenyl)-3H-1,4-benzodiazepin-2(1H)-one dihydrochloride
7-chloro-1-[2-(diethylamino)ethyl]-5-(2-fluorophenyl)-3H-1,4-benzodiazepin-2-one;dihydrochloride
756RDM536M
AC1L23TS
Benozil
CHEBI:5129
CHEMBL3989724
D00695
Dalmadorm
Dalmane (TN)
Dalmate
DTXSID3025334
EINECS 214-630-0
Felison
Flurazepam dihydrochloride
FLURAZEPAM DIHYDROCHLORIDE (SEE ALSO FLURAZEPAM (17617-23-1))
Flurazepam dihydrochloride, drug standard, 1.0 mg/mL in methanol
Flurazepam dihydrochloride, solid
Flurazepam HCL
Flurazepam hydrochloride (USP)
Flurazepam hydrochloride [USAN:JAN]
Flurazepam hydrochloride [USAN:USP:JAN]
Flurazepam hydrochloride, United States Pharmacopeia (USP) Reference Standard
FT-0603548
ID 480
Insumin
Insumin dihydrochloride
Linzac
LS-595
Lunipax
Natam
NSC-78559
Ro 5-6901
Ro-56901
SCHEMBL29792
Somlan
UNII-756RDM536M
W-108568

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
Heritage Pharma FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 072369-001 Mar 30, 1989 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
Hikma Intl Pharms FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071107-001 Dec 8, 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
Superpharm FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071659-001 Aug 4, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 071717-001 Jul 31, 1991 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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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.