Diazepam - Generic Drug Details

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, Chartwell Molecular, Hikma, Bausch, Abraxis Pharm, Beloteca Inc, Fresenius Kabi Usa, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, 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, Strides Pharma, Teva Pharms, Upsher Smith Labs, Virtus Pharms, Quantum Pharmics, and Waylis Therap, and is included in eighty-six 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 eighty-four patent family members in twenty-three countries.

There are eight drug master file entries for diazepam. Forty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for diazepam

International Patents:	84
US Patents:	5
Tradenames:	9
Applicants:	35
NDAs:	86
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	135
Patent Applications:	6,480
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
University of Guadalajara	Phase 2
Institute of Experimental and Clinical Therapeutics	Phase 2
Hospital Civil de Guadalajara	Phase 2

See all diazepam clinical trials

Generic filers with tentative approvals for DIAZEPAM

Applicant	Application No.	Strength	Dosage Form
		10MG	FILM;BUCCAL
		7.5MG	FILM;BUCCAL
		5MG	FILM;BUCCAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	Strength	NDA	ANDAs Submitted	Submissiondate
DIASTAT ACUDIAL	Rectal Gel	diazepam	5 mg/mL, 2mL pre-filled syringe	020648	1	2008-12-23
DIASTAT ACUDIAL	Rectal Gel	diazepam	5 mg/mL, 4mL pre- filled syringe	020648	1	2008-12-08
DIASTAT ACUDIAL	Rectal Gel	diazepam	2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL 15 mg/3 mL 20 mg/4 mL	020648	1	2004-03-23

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	211635-001	Jan 10, 2020		RX	Yes	No			Y
Pharmacia And Upjohn	DIZAC	diazepam	INJECTABLE;INJECTION	019287-001	Jun 18, 1993		DISCN	No	No
Hospira	DIAZEPAM	diazepam	INJECTABLE;INJECTION	072079-001	Dec 20, 1988	AP	RX	No	No
Ivax Sub Teva Pharms	DIAZEPAM	diazepam	TABLET;ORAL	071322-001	Dec 10, 1986	AB	RX	No	No
Mylan	DIAZEPAM	diazepam	TABLET;ORAL	070325-002	Sep 4, 1985	AB	RX	No	No
Beloteca Inc	DIAZEPAM	diazepam	INJECTABLE;INJECTION	210363-001	Mar 18, 2019	AP	RX	No	Yes

Expired US Patents for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Pharmacia And Upjohn	DIZAC	diazepam	INJECTABLE;INJECTION	019287-001	Jun 18, 1993
Roche	VALIUM	diazepam	INJECTABLE;INJECTION	016087-001	Approved Prior to Jan 1, 1982
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997

International Patents for diazepam

Country	Patent Number	Title	Estimated Expiration
Spain	2791775	FORMULACIONES DE EPINEFRINA INTRANASAL Y METODOS PARA EL TRATAMIENTO DE ENFERMEDADES (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
Denmark	2720699
European Patent Office	2720699	ADMINISTRATION DE BENZODIAZÉPINE (ADMINISTRATION OF BENZODIAZEPINE)
Canada	2814927	COMPOSITIONS POUR L'ADMINISTRATION DE MEDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION)
China	103189068	Compositions for drug administration
Mexico	2011006790	COMPOSICIONES PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.)