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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 fifty-three patent family members in thirteen countries.

There are eight drug master file entries for diazepam. Forty suppliers are listed for this compound.

Summary for diazepam

International Patents:	53
US Patents:	5
Tradenames:	9
Applicants:	34
NDAs:	85
Drug Master File Entries:	8
Suppliers / Packagers:	40
Bulk Api Vendors:	57
Clinical Trials:	110
Patent Applications:	6,199
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
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
Queen Sirikit National Institute of Child Health	N/A
TriHealth Inc.	Phase 4
Swedish Medical Center	Phase 4

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	GEL;RECTAL	diazepam	020648	2008-12-08
DIASTAT ACUDIAL	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
Watson Labs Inc	DIAZEPAM	diazepam	INJECTABLE;INJECTION	072370-001	Jan 29, 1993		DISCN	No	No
Ivax Sub Teva Pharms	DIAZEPAM	diazepam	TABLET;ORAL	070361-001	Sep 4, 1985		DISCN	No	No
Quantum Pharmics	Q-PAM	diazepam	TABLET;ORAL	070425-001	Dec 12, 1985		DISCN	No	No
Abraxis Pharm	DIAZEPAM	diazepam	INJECTABLE;INJECTION	070662-001	Jun 25, 1986		DISCN	No	No
Pioneer Pharms	DIAZEPAM	diazepam	TABLET;ORAL	070787-001	Aug 2, 1988		DISCN	No	No

Expired US Patents for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia And Upjohn	DIZAC	diazepam	INJECTABLE;INJECTION	019287-001	Jun 18, 1993
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997
Roche	VALRELEASE	diazepam	CAPSULE, EXTENDED RELEASE;ORAL	018179-001	Approved Prior to Jan 1, 1982
Roche	VALIUM	diazepam	INJECTABLE;INJECTION	016087-001	Approved Prior to Jan 1, 1982
Roche	VALIUM	diazepam	TABLET;ORAL	013263-004	Approved Prior to Jan 1, 1982

International Patents for diazepam

Country	Patent Number	Estimated Expiration
Japan	2015108008
Denmark	2381773
Spain	2683902
China	103189068
Mexico	356271