DIAZEPAM - Generic Drug Details

What are the generic sources for diazepam and what is the scope of patent protection?

Diazepam is the generic ingredient in nine branded drugs marketed by Roche, Chartwell Molecular, Hikma, Bausch, Novel Labs Inc, Abraxis Pharm, Beloteca, 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, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dava Pharms Inc, Dr Reddys Labs Sa, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, Virtus, Quantum Pharmics, and Waylis Therap, and is included in eighty-eight NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diazepam has ninety-seven patent family members in twenty-eight countries.

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

Summary for DIAZEPAM

International Patents:	97
US Patents:	6
Tradenames:	9
Applicants:	37
NDAs:	88
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	138
Patent Applications:	6,439
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
Assiut University	N/A
Kuwait University	Early Phase 1
University of Guadalajara	Phase 2

See all DIAZEPAM clinical trials

Generic filers with tentative approvals for DIAZEPAM

Applicant	Application No.	Strength	Dosage Form
		20MG	FILM;BUCCAL
		17.5MG	FILM;BUCCAL
		15MG	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
VALTOCO	Nasal Spray	diazepam	10 mg/spray	211635	1	2024-02-14
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
Warner Chilcott	DIAZEPAM	diazepam	INJECTABLE;INJECTION	071614-001	Oct 22, 1987		DISCN	No	No
Dr Reddys Labs Sa	DIAZEPAM	diazepam	TABLET;ORAL	071134-001	Feb 3, 1987	AB	RX	No	No
Hospira	DIAZEPAM	diazepam	INJECTABLE;INJECTION	071584-001	Oct 13, 1987		DISCN	No	No
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No			Y
Halsey	DIAZEPAM	diazepam	TABLET;ORAL	070996-001	Aug 15, 1986		DISCN	No	No
Abraxis Pharm	DIAZEPAM	diazepam	INJECTABLE;INJECTION	070662-001	Jun 25, 1986		DISCN	No	No
Hikma	DIAZEPAM INTENSOL	diazepam	CONCENTRATE;ORAL	071415-001	Apr 3, 1987	AA	RX	No	Yes

Expired US Patents for DIAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-007	Sep 15, 2005
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-002	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
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-004	Approved Prior to Jan 1, 1982
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-006	Approved Prior to Jan 1, 1982
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997

International Patents for DIAZEPAM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3082817	COMPOSITIONS POUR ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION)
Russian Federation	2011130526	КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ
United Kingdom	2583051	Intranasal epinephrine formulations and methods for the treatment of disease
World Intellectual Property Organization (WIPO)	2015095389
Canada	3088989	FORMULATIONS D'EPINEPHRINE INTRANASALE ET METHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
Australia	2011317202	Compositions for drug administration
South Korea	20240019858	비강내 에피네프린 제제 및 질환의 치료 방법 (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)