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Last Updated: March 29, 2024

DIAZEPAM Drug Patent Profile


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Which patents cover Diazepam, and what generic alternatives are available?

Diazepam is a drug marketed by Chartwell Molecular, Novel Labs Inc, Abraxis Pharm, Beloteca, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs 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, and Virtus. and is included in seventy-six NDAs.

The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diazepam

A generic version of DIAZEPAM was approved as diazepam by MYLAN on September 4th, 1985.

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Drug patent expirations by year for DIAZEPAM
Drug Prices for DIAZEPAM

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Drug Sales Revenue Trends for DIAZEPAM

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Recent Clinical Trials for DIAZEPAM

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SponsorPhase
Assiut UniversityN/A
Kuwait UniversityEarly Phase 1
University of GuadalajaraPhase 2

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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
Roxane DIAZEPAM diazepam TABLET;ORAL 070356-001 Jun 17, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx DIAZEPAM diazepam TABLET;ORAL 070303-001 Dec 20, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth DIAZEPAM diazepam TABLET;ORAL 070781-001 Mar 19, 1986 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

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