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Last Updated: July 12, 2020

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MITIGARE Drug Profile


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

Mitigare is a drug marketed by Hikma Intl Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in MITIGARE is colchicine. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the colchicine profile page.

US ANDA Litigation and Generic Entry Outlook for Mitigare

A generic version of MITIGARE was approved as colchicine by AMNEAL PHARMS on September 28th, 2016.

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Paragraph IV (Patent) Challenges for MITIGARE
Tradename Dosage Ingredient NDA Submissiondate
MITIGARE CAPSULE;ORAL colchicine 204820 2016-06-10

US Patents and Regulatory Information for MITIGARE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes   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:

AstraZeneca
Mallinckrodt
Dow
Baxter
McKesson
Colorcon

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