You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 12, 2024

DIAZEPAM - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for DIAZEPAM

See drug prices for DIAZEPAM

Drug Sales Revenue Trends for DIAZEPAM

See drug sales revenues for DIAZEPAM

Recent Clinical Trials for DIAZEPAM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of JordanPhase 3
Assiut UniversityN/A
Walter Reed National Military Medical CenterPhase 2

See all DIAZEPAM clinical trials

Generic filers with tentative approvals for DIAZEPAM
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up17.5MGFILM;BUCCAL
⤷  Sign Up⤷  Sign Up15MGFILM;BUCCAL
⤷  Sign Up⤷  Sign Up12.5MGFILM;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 ClassBenzodiazepine
Anatomical Therapeutic Chemical (ATC) Classes for DIAZEPAM
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
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-007 Sep 15, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Hikma DIAZEPAM diazepam INJECTABLE;INJECTION 070313-001 Dec 16, 1985 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma DIAZEPAM INTENSOL diazepam CONCENTRATE;ORAL 071415-001 Apr 3, 1987 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-001 Jul 29, 1997 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-006 Sep 15, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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

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

International Patents for DIAZEPAM

Country Patent Number Title Estimated Expiration
China 103189068 Compositions for drug administration ⤷  Sign Up
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
Australia 2011317202 Compositions for drug administration ⤷  Sign Up
Canada 2814927 COMPOSITIONS POUR L'ADMINISTRATION DE MEDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) ⤷  Sign Up
China 110505873 鼻内肾上腺素制剂及治疗疾病的方法 (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE) ⤷  Sign Up
South Korea 20200121818 비강내 에피네프린 제제 및 질환의 치료 방법 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.