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Last Updated: April 19, 2021

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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 sixty-five patent family members in eighteen countries.

There are eight drug master file entries for diazepam. Thirty-nine 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
Ehab Tarek FahmyPhase 1
PfizerPhase 4
Queen Sirikit National Institute of Child HealthN/A

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 ACUDIAL GEL;RECTAL diazepam 020648 2008-12-08
DIASTAT 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
Bausch DIASTAT diazepam GEL;RECTAL 020648-005 Jul 29, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Dava Pharms Inc DIAZEPAM diazepam TABLET;ORAL 070228-001 Sep 26, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs DIAZEPAM diazepam TABLET;ORAL 070303-001 Dec 20, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Watson Labs DIAZEPAM diazepam INJECTABLE;INJECTION 070930-001 Dec 1, 1986 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
Bausch DIASTAT diazepam GEL;RECTAL 020648-002 Jul 29, 1997   Start Trial   Start Trial
Bausch DIASTAT diazepam GEL;RECTAL 020648-003 Jul 29, 1997   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 TABLET;ORAL 013263-004 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
Bausch DIASTAT diazepam GEL;RECTAL 020648-005 Jul 29, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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