Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Express Scripts
Colorcon
Mallinckrodt
AstraZeneca

Last Updated: June 24, 2022

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 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.

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
Mayo ClinicPhase 1/Phase 2
RenJi HospitalPhase 4
University of CincinnatiPhase 4

See all diazepam clinical trials

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
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abraxis Pharm DIAZEPAM diazepam INJECTABLE;INJECTION 070662-001 Jun 25, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Halsey DIAZEPAM diazepam TABLET;ORAL 070956-001 Aug 15, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Warner Chilcott DIAZEPAM diazepam TABLET;ORAL 070222-001 Sep 4, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs DIAZEPAM diazepam INJECTABLE;INJECTION 070296-001 Feb 12, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma DIAZEPAM diazepam INJECTABLE;INJECTION 070313-001 Dec 16, 1985 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Bausch DIASTAT diazepam GEL;RECTAL 020648-003 Jul 29, 1997 See Plans and Pricing See Plans and Pricing
Bausch DIASTAT diazepam GEL;RECTAL 020648-005 Jul 29, 1997 See Plans and Pricing See Plans and Pricing
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-007 Sep 15, 2005 See Plans and Pricing See Plans and Pricing
Roche VALRELEASE diazepam CAPSULE, EXTENDED RELEASE;ORAL 018179-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Bausch DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997 See Plans and Pricing See Plans and Pricing
Roche VALIUM diazepam INJECTABLE;INJECTION 016087-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for diazepam

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

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Moodys
Colorcon
Medtronic
Dow

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.