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Last Updated: February 2, 2023

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 nine branded drugs marketed by Roche, Chartwell Molecular, Hikma, Bausch, Abraxis Pharm, Beloteca Inc, 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, 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-six 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 eighty-four patent family members in twenty-three countries.

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

Drug Prices for diazepam

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Drug Sales Revenue Trends for diazepam

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Recent Clinical Trials for diazepam

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

SponsorPhase
University of GuadalajaraPhase 2
Institute of Experimental and Clinical TherapeuticsPhase 2
Hospital Civil de GuadalajaraPhase 2

See all diazepam clinical trials

Generic filers with tentative approvals for DIAZEPAM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10MGFILM;BUCCAL
See Plans and PricingSee Plans and Pricing7.5MGFILM;BUCCAL
See Plans and PricingSee Plans and Pricing5MGFILM;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
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
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacia And Upjohn DIZAC diazepam INJECTABLE;INJECTION 019287-001 Jun 18, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira DIAZEPAM diazepam INJECTABLE;INJECTION 072079-001 Dec 20, 1988 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ivax Sub Teva Pharms DIAZEPAM diazepam TABLET;ORAL 071322-001 Dec 10, 1986 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan DIAZEPAM diazepam TABLET;ORAL 070325-002 Sep 4, 1985 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Beloteca Inc DIAZEPAM diazepam INJECTABLE;INJECTION 210363-001 Mar 18, 2019 AP RX No Yes 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 020648-004 Jul 29, 1997 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
Pharmacia And Upjohn DIZAC diazepam INJECTABLE;INJECTION 019287-001 Jun 18, 1993 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
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-006 Sep 15, 2005 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for diazepam

Country Patent Number Title Estimated Expiration
Spain 2791775 FORMULACIONES DE EPINEFRINA INTRANASAL Y METODOS PARA EL TRATAMIENTO DE ENFERMEDADES (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE) See Plans and Pricing
Denmark 2720699 See Plans and Pricing
European Patent Office 2720699 ADMINISTRATION DE BENZODIAZÉPINE (ADMINISTRATION OF BENZODIAZEPINE) See Plans and Pricing
Canada 2814927 COMPOSITIONS POUR L'ADMINISTRATION DE MEDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) See Plans and Pricing
China 103189068 Compositions for drug administration See Plans and Pricing
Mexico 2011006790 COMPOSICIONES PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.