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Last Updated: October 27, 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 Pharms, Bausch, Abraxis Pharm, Beloteca Inc, Hikma, 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 seventy-two patent family members in twenty 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
Shaheed Zulfiqar Ali Bhutto Medical UniversityPhase 4
Ontario Ministry of Health and Long Term CareN/A
Centre for Addiction and Mental 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
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Roche VALIUM diazepam INJECTABLE;INJECTION 016087-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Warner Chilcott DIAZEPAM diazepam TABLET;ORAL 070222-001 Sep 4, 1985 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Lannett Co Inc DIAZEPAM diazepam SOLUTION;ORAL 206477-001 Jun 24, 2016 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nuvo Pharm DIAZEPAM diazepam TABLET;ORAL 070464-001 Feb 25, 1986 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
West-ward Pharms Int DIAZEPAM diazepam INJECTABLE;INJECTION 071310-001 Jul 17, 1987 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Warner Chilcott DIAZEPAM diazepam TABLET;ORAL 070209-001 Sep 4, 1985 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Roche VALRELEASE diazepam CAPSULE, EXTENDED RELEASE;ORAL 018179-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Roche VALIUM diazepam INJECTABLE;INJECTION 016087-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Roche VALIUM diazepam TABLET;ORAL 013263-006 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-007 Sep 15, 2005 ⤷  Try it Free ⤷  Try it Free
Roche VALIUM diazepam TABLET;ORAL 013263-004 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Bausch DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997 ⤷  Try it Free ⤷  Try it Free
Roche VALIUM diazepam TABLET;ORAL 013263-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Express Scripts
Moodys
Dow
Mallinckrodt

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