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Last Updated: March 19, 2024

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, 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
Institute of Experimental and Clinical TherapeuticsPhase 2

See all diazepam clinical trials

Generic filers with tentative approvals for DIAZEPAM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial15MGFILM;BUCCAL
⤷  Try a Trial⤷  Try a Trial12.5MGFILM;BUCCAL
⤷  Try a Trial⤷  Try a Trial10MGFILM;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 211635-003 Jan 10, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ivax Sub Teva Pharms DIAZEPAM diazepam TABLET;ORAL 070362-001 Sep 4, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Warner Chilcott DIAZEPAM diazepam TABLET;ORAL 070210-001 Sep 4, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan DIAZEPAM diazepam TABLET;ORAL 070325-003 Sep 4, 1985 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 070425-001 Dec 12, 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

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