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Last Updated: June 12, 2021

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DIAZEPAM Drug Profile


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Which patents cover Diazepam, and what generic alternatives are available?

Diazepam is a drug marketed by Lannett Co Inc, Abraxis Pharm, Beloteca Inc, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Hikma, 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, and Virtus Pharms. and is included in seventy-three NDAs.

The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diazepam

A generic version of DIAZEPAM was approved as diazepam by MYLAN on September 4th, 1985.

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Drug patent expirations by year for DIAZEPAM
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
Shaheed Zulfiqar Ali Bhutto Medical UniversityPhase 4
Canadian Institutes of Health Research (CIHR)N/A
Ontario Ministry of Health and Long Term CareN/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
Virtus Pharms DIAZEPAM diazepam TABLET;ORAL 070463-001 Feb 25, 1986 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Halsey DIAZEPAM diazepam TABLET;ORAL 070987-001 Aug 15, 1986 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Dava Pharms Inc DIAZEPAM diazepam TABLET;ORAL 070228-002 Sep 26, 1985 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Ivax Sub Teva Pharms DIAZEPAM diazepam TABLET;ORAL 071322-001 Dec 10, 1986 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Pioneer Pharms DIAZEPAM diazepam TABLET;ORAL 070776-001 Aug 2, 1988 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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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