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Last Updated: June 12, 2021

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DIASTAT Drug 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. Thirty-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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Drug patent expirations by year for DIASTAT
Drug Prices for DIASTAT

See drug prices for DIASTAT

Recent Clinical Trials for DIASTAT

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

SponsorPhase
Aquestive TherapeuticsPhase 1/Phase 2
Acorda TherapeuticsPhase 2
University of Minnesota - Clinical and Translational Science InstitutePhase 1

See all DIASTAT clinical trials

Pharmacology for DIASTAT
Drug ClassBenzodiazepine
Paragraph IV (Patent) Challenges for DIASTAT
Tradename Dosage Ingredient NDA Submissiondate
DIASTAT ACUDIAL GEL;RECTAL diazepam 020648 2008-12-23
DIASTAT GEL;RECTAL diazepam 020648 2008-12-23
DIASTAT ACUDIAL GEL;RECTAL diazepam 020648 2008-12-08
DIASTAT GEL;RECTAL diazepam 020648 2008-12-08
DIASTAT ACUDIAL GEL;RECTAL diazepam 020648 2004-03-23
DIASTAT GEL;RECTAL diazepam 020648 2004-03-23

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 No   Get Started Free   Get Started Free   Get Started Free
Bausch DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-006 Sep 15, 2005 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Bausch DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Bausch DIASTAT diazepam GEL;RECTAL 020648-002 Jul 29, 1997 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Bausch DIASTAT diazepam GEL;RECTAL 020648-003 Jul 29, 1997   Get Started Free   Get Started Free
Bausch DIASTAT diazepam GEL;RECTAL 020648-005 Jul 29, 1997   Get Started Free   Get Started Free
Bausch DIASTAT diazepam GEL;RECTAL 020648-002 Jul 29, 1997   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Harvard Business School
Mallinckrodt
Merck
McKinsey

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