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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.

Summary for diazepam

International Patents:	72
US Patents:	5
Tradenames:	9
Applicants:	35
NDAs:	85
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	118
Patent Applications:	6,552
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for diazepam
Drug Sales Revenues:	Drug sales revenues for diazepam
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diazepam
What excipients (inactive ingredients) are in diazepam?	diazepam excipients list
DailyMed Link:	diazepam at DailyMed

See drug prices for diazepam

See drug sales revenues for diazepam

Recent Clinical Trials for diazepam

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

Sponsor	Phase
Shaheed Zulfiqar Ali Bhutto Medical University	Phase 4
Ontario Ministry of Health and Long Term Care	N/A
Centre for Addiction and Mental Health	N/A

See all diazepam clinical trials

Pharmacology for diazepam

Drug Class	Benzodiazepine

Medical Subject Heading (MeSH) Categories for diazepam

Adjuvants, Anesthesia
Anesthetics, Intravenous
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives
Muscle Relaxants, Central

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

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Glossary

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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

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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

International Patents for diazepam

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Country	Patent Number	Estimated Expiration
South Korea	101719008	⤷ Try it Free
United Kingdom	2583051	⤷ Try it Free
United Kingdom	2587934	⤷ Try it Free
Japan	6883918	⤷ Try it Free
United Kingdom	202012086	⤷ Try it Free
Australia	2011317202	⤷ Try it Free
South Korea	20200121818	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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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 verification 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.