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Last Updated: August 7, 2020

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GLYNASE Drug Profile

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

Glynase is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in GLYNASE is glyburide. There are twenty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the glyburide profile page.

US ANDA Litigation and Generic Entry Outlook for Glynase

A generic version of GLYNASE was approved as glyburide by TEVA on August 29th, 1995.

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Drug patent expirations by year for GLYNASE
Drug Prices for GLYNASE

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Recent Clinical Trials for GLYNASE

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SponsorPhase
Medical College of WisconsinPhase 4
TakedaPhase 4
TakedaPhase 3

See all GLYNASE clinical trials

Pharmacology for GLYNASE
Drug ClassSulfonylurea
Paragraph IV (Patent) Challenges for GLYNASE
Tradename Dosage Ingredient NDA Submissiondate
GLYNASE TABLET;ORAL glyburide 020051

US Patents and Regulatory Information for GLYNASE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-004 Sep 24, 1993 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-002 Mar 4, 1992 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-003 Sep 24, 1993 DISCN Yes No   Start Trial   Start Trial   Start 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 GLYNASE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-003 Sep 24, 1993   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-002 Mar 4, 1992   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-004 Sep 24, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Colorcon
Baxter
Mallinckrodt
Merck

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