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Last Updated: November 21, 2024

DIASTAT Drug Patent Profile


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Which patents cover Diastat, and when can generic versions of Diastat launch?

Diastat is a drug marketed by Bausch and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Diastat

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

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Summary for DIASTAT
Drug patent expirations by year for DIASTAT
Drug Prices for DIASTAT

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Recent Clinical Trials for DIASTAT

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

SponsorPhase
Aquestive TherapeuticsPhase 1/Phase 2
Acorda TherapeuticsPhase 2
University of MinnesotaPhase 1

See all DIASTAT clinical trials

US Patents and Regulatory Information for DIASTAT

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 020648-001 Jul 29, 1997 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-006 Sep 15, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-002 Jul 29, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-003 Jul 29, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-007 Sep 15, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 DIASTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch DIASTAT diazepam GEL;RECTAL 020648-001 Jul 29, 1997 ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997 ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-005 Jul 29, 1997 ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-003 Jul 29, 1997 ⤷  Sign Up ⤷  Sign Up
Bausch DIASTAT diazepam GEL;RECTAL 020648-002 Jul 29, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DIASTAT

See the table below for patents covering DIASTAT around the world.

Country Patent Number Title Estimated Expiration
Canada 2171627 COMPOSITION ADMINISTREE PAR VOIE RECTALE, POUR EMPECHER LES CRISES D'EPILEPSIE (RECTALLY-ADMINISTERED, EPILEPTIC-SEIZURE-INHIBITING COMPOSITION) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9507672 ⤷  Sign Up
Australia 7686394 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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