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Last Updated: August 4, 2020

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COLCRYS Drug Profile

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Which patents cover Colcrys, and what generic alternatives are available?

Colcrys is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in COLCRYS 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 Colcrys

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

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Drug patent expirations by year for COLCRYS
Drug Prices for COLCRYS

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Drug Sales Revenue Trends for COLCRYS

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Recent Clinical Trials for COLCRYS

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SponsorPhase
University of California, Los AngelesPhase 2
National Center for Advancing Translational Science (NCATS)Phase 2
University of PennsylvaniaPhase 2

See all COLCRYS clinical trials

Pharmacology for COLCRYS
Paragraph IV (Patent) Challenges for COLCRYS
Tradename Dosage Ingredient NDA Submissiondate
COLCRYS TABLET;ORAL colchicine 022352 2019-07-19
COLCRYS TABLET;ORAL colchicine 022352 2011-12-23

US Patents and Regulatory Information for COLCRYS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB 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:

Medtronic
Merck
Boehringer Ingelheim
Colorcon
Mallinckrodt
AstraZeneca

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