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Last Updated: January 28, 2021

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CEFTIN Drug Profile

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

Ceftin is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in CEFTIN is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

US ANDA Litigation and Generic Entry Outlook for Ceftin

A generic version of CEFTIN was approved as cefuroxime axetil by APOTEX on October 2nd, 2002.

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US Patents and Regulatory Information for CEFTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline CEFTIN cefuroxime axetil FOR SUSPENSION;ORAL 050672-001 Jun 30, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline CEFTIN cefuroxime axetil TABLET;ORAL 050605-002 Dec 28, 1987 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline CEFTIN cefuroxime axetil FOR SUSPENSION;ORAL 050672-002 Apr 29, 1997 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

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Mallinckrodt
Moodys
AstraZeneca
Baxter

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