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Last Updated: March 28, 2024

DIASTAT ACUDIAL Drug Patent Profile


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When do Diastat Acudial patents expire, and what generic alternatives are available?

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

The generic ingredient in DIASTAT ACUDIAL 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 Diastat Acudial

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

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Paragraph IV (Patent) Challenges for DIASTAT ACUDIAL
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 DIASTAT ACUDIAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-007 Sep 15, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-006 Sep 15, 2005 AB RX Yes Yes ⤷  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

International Patents for DIASTAT ACUDIAL

See the table below for patents covering DIASTAT ACUDIAL 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) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9507672 ⤷  Try a Trial
Australia 7686394 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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