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, Lannett Co Inc, Hikma, Bausch, Abraxis Pharm, Beloteca Inc, 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-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-eight 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:	78
US Patents:	5
Tradenames:	9
Applicants:	34
NDAs:	85
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	134
Patent Applications:	6,512
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
Mayo Clinic	Phase 1/Phase 2
RenJi Hospital	Phase 4
University of Cincinnati	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

Anatomical Therapeutic Chemical (ATC) Classes for diazepam

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997		DISCN	Yes	No
Abraxis Pharm	DIAZEPAM	diazepam	INJECTABLE;INJECTION	070662-001	Jun 25, 1986		DISCN	No	No
Halsey	DIAZEPAM	diazepam	TABLET;ORAL	070956-001	Aug 15, 1986		DISCN	No	No
Warner Chilcott	DIAZEPAM	diazepam	TABLET;ORAL	070222-001	Sep 4, 1985		DISCN	No	No
Watson Labs	DIAZEPAM	diazepam	INJECTABLE;INJECTION	070296-001	Feb 12, 1986		DISCN	No	No
Hikma	DIAZEPAM	diazepam	INJECTABLE;INJECTION	070313-001	Dec 16, 1985	AP	RX	No	No

Expired US Patents for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-003	Jul 29, 1997
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-007	Sep 15, 2005
Roche	VALRELEASE	diazepam	CAPSULE, EXTENDED RELEASE;ORAL	018179-001	Approved Prior to Jan 1, 1982
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997
Roche	VALIUM	diazepam	INJECTABLE;INJECTION	016087-001	Approved Prior to Jan 1, 1982

International Patents for diazepam

Country	Patent Number	Title	Estimated Expiration
Brazil	112020015646	formulações intranasais de epinefrina e métodos para o tratamento de doença
China	107737100	苯二氮卓组合物的投与 (Administration of benzodiazepine)
Denmark	2381773
China	103189068	Compositions for drug administration
Canada	3088989	FORMULATIONS D'EPINEPHRINE INTRANASALE ET METHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
Mexico	356271	COMPOSICIONES DE ALQUILGLICÓSIDO PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.)