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Last Updated: September 29, 2020

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Diazepam - Generic Drug Details

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

Diazepam is the generic ingredient in nine branded drugs marketed by Roche, Lannett Co Inc, Hikma, Bausch, Abraxis Pharm, Beloteca Inc, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Pharmacia And Upjohn, Neurelis Inc, Actavis Elizabeth, Barr, Dava Pharms Inc, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mayne Pharma, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Teva Pharms, Upsher Smith Labs, Vintage Pharms, Virtus Pharms, and Quantum Pharmics, and is included in eighty-five NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diazepam has fifty-three patent family members in thirteen countries.

There are eight drug master file entries for diazepam. Forty suppliers are listed for this compound.

Drug Prices for diazepam

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Drug Sales Revenue Trends for diazepam

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Recent Clinical Trials for diazepam

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

SponsorPhase
Queen Sirikit National Institute of Child HealthN/A
TriHealth Inc.Phase 4
Swedish Medical CenterPhase 4

See all diazepam clinical trials

Pharmacology for diazepam
Drug ClassBenzodiazepine
Paragraph IV (Patent) Challenges for DIAZEPAM
Tradename Dosage Ingredient NDA Submissiondate
DIASTAT ACUDIAL GEL;RECTAL diazepam 020648 2008-12-23
DIASTAT GEL;RECTAL diazepam 020648 2008-12-23
DIASTAT GEL;RECTAL diazepam 020648 2008-12-08
DIASTAT ACUDIAL GEL;RECTAL diazepam 020648 2008-12-08
DIASTAT ACUDIAL GEL;RECTAL diazepam 020648 2004-03-23
DIASTAT GEL;RECTAL diazepam 020648 2004-03-23
VALIUM TABLET;ORAL diazepam 013263

US Patents and Regulatory Information for diazepam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Inc DIAZEPAM diazepam INJECTABLE;INJECTION 072370-001 Jan 29, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms DIAZEPAM diazepam TABLET;ORAL 070361-001 Sep 4, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 070425-001 Dec 12, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Abraxis Pharm DIAZEPAM diazepam INJECTABLE;INJECTION 070662-001 Jun 25, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Pioneer Pharms DIAZEPAM diazepam TABLET;ORAL 070787-001 Aug 2, 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 diazepam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn DIZAC diazepam INJECTABLE;INJECTION 019287-001 Jun 18, 1993   Start Trial   Start Trial
Bausch DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997   Start Trial   Start Trial
Roche VALRELEASE diazepam CAPSULE, EXTENDED RELEASE;ORAL 018179-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Roche VALIUM diazepam INJECTABLE;INJECTION 016087-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Roche VALIUM diazepam TABLET;ORAL 013263-004 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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