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 ten branded drugs marketed by Roche, Chartwell Molecular, Hikma, Aquestive, Bausch, Novel Labs Inc, Abraxis Pharm, Alembic, Beloteca, Dr Reddys, 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, Dr Reddys Labs Sa, Duramed Pharms Barr, Endo Operations, 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 ninety-one NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diazepam has one hundred and eighteen patent family members in twenty-eight countries.

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

Summary for diazepam

International Patents:	118
US Patents:	7
Tradenames:	10
Applicants:	40
NDAs:	91
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	142
Patent Applications:	6,517
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 Jordan	Phase 3
Assiut University	N/A
Walter Reed National Military Medical Center	Phase 2

See all diazepam clinical trials

Generic filers with tentative approvals for DIAZEPAM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	20MG	FILM;BUCCAL
⤷ Sign Up	⤷ Sign Up	17.5MG	FILM;BUCCAL
⤷ Sign Up	⤷ Sign Up	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

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
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

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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
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Strides Pharma	DIAZEPAM	diazepam	TABLET;ORAL	077749-001	Mar 31, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pioneer Pharms	DIAZEPAM	diazepam	TABLET;ORAL	070787-001	Aug 2, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nuvo Pharm	DIAZEPAM	diazepam	TABLET;ORAL	070464-003	Sep 10, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aquestive	LIBERVANT	diazepam	FILM;BUCCAL	218623-005	Apr 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 ACUDIAL	diazepam	GEL;RECTAL	020648-007	Sep 15, 2005	⤷ Sign Up	⤷ Sign Up
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-004	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Roche	VALRELEASE	diazepam	CAPSULE, EXTENDED RELEASE;ORAL	018179-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005	⤷ Sign Up	⤷ Sign Up
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-006	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pharmacia And Upjohn	DIZAC	diazepam	INJECTABLE;INJECTION	019287-001	Jun 18, 1993	⤷ Sign Up	⤷ Sign Up
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for diazepam

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Country	Patent Number	Title	Estimated Expiration
Japan	2021193091	疾患の処置のための鼻腔内エピネフリン製剤及び方法 (INTRANASAL EPINEPHRINE PREPARATIONS AND METHODS FOR TREATMENT OF DISEASE)	⤷ Sign Up
Israel	276485	פורמולציות של אפינפרין תוך-אפיות ושיטות לטיפול במחלה (Intranasal epinephrine formulations and methods for the treatment of disease)	⤷ Sign Up
Japan	2019163273	ベンゾジアゼピン組成物の投与 (ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS)	⤷ Sign Up
Spain	2683902		⤷ Sign Up
European Patent Office	4085899	ADMINISTRATION DE BENZODIAZÉPINE (ADMINISTRATION OF BENZODIAZEPINE)	⤷ Sign Up
Hong Kong	1164059	用於給藥的組合物 (COMPOSITIONS FOR DRUG ADMINISTRATION)	⤷ Sign Up
Canada	3088989	FORMULATIONS D'EPINEPHRINE INTRANASALE ET METHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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