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.

Summary for diazepam

International Patents:	65
US Patents:	5
Tradenames:	9
Applicants:	34
NDAs:	85
Drug Master File Entries:	8
Suppliers / Packagers:	39
Bulk Api Vendors:	59
Clinical Trials:	114
Patent Applications:	6,547
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
Ehab Tarek Fahmy	Phase 1
Pfizer	Phase 4
Queen Sirikit National Institute of Child 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
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

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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

International Patents for diazepam

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Country	Patent Number	Estimated Expiration
Japan	5752048	Start Trial
European Patent Office	2271347	Start Trial
South Korea	20110099049	Start Trial
Russian Federation	2554814	Start Trial
European Patent Office	3082817	Start Trial
Australia	2009228093	Start Trial
Japan	2019163273	Start Trial
>Country	>Patent Number	>Estimated Expiration

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