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Last Updated: March 18, 2024

Diazepam - Generic Drug Details


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What are the generic sources for diazepam and what is the scope of patent protection?

Diazepam is the generic ingredient in nine branded drugs marketed by Roche, Chartwell Molecular, Hikma, Bausch, Novel Labs Inc, Abraxis Pharm, Beloteca, 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, Dava Pharms Inc, Dr Reddys Labs Sa, Duramed Pharms Barr, 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 eighty-eight NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diazepam has ninety-seven patent family members in twenty-eight countries.

There are eight drug master file entries for diazepam. Forty-two 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
Assiut UniversityN/A
Kuwait UniversityEarly Phase 1
University of GuadalajaraPhase 2

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Generic filers with tentative approvals for DIAZEPAM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial20MGFILM;BUCCAL
⤷  Try a Trial⤷  Try a Trial17.5MGFILM;BUCCAL
⤷  Try a Trial⤷  Try a Trial15MGFILM;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 211635-002 Jan 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma DIAZEPAM diazepam INJECTABLE;INJECTION 070311-002 Dec 16, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma DIAZEPAM diazepam TABLET;ORAL 077749-001 Mar 31, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hikma DIAZEPAM diazepam INJECTABLE;INJECTION 070311-003 Dec 16, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ACUDIAL diazepam GEL;RECTAL 020648-006 Sep 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
Roche VALRELEASE diazepam CAPSULE, EXTENDED RELEASE;ORAL 018179-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Bausch DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997 ⤷  Try a Trial ⤷  Try a Trial
Bausch DIASTAT diazepam GEL;RECTAL 020648-005 Jul 29, 1997 ⤷  Try a Trial ⤷  Try a Trial
Waylis Therap VALIUM diazepam TABLET;ORAL 013263-004 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for diazepam

Country Patent Number Title Estimated Expiration
Hungary E060917 ⤷  Try a Trial
China 103189068 Compositions for drug administration ⤷  Try a Trial
Hong Kong 1164059 用於給藥的組合物 (COMPOSITIONS FOR DRUG ADMINISTRATION) ⤷  Try a Trial
Denmark 2381773 ⤷  Try a Trial
Russian Federation 2011130526 КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ ⤷  Try a Trial
>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.