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Last Updated: October 23, 2021

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Colchicine - Generic Drug Details

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What are the generic drug sources for colchicine and what is the scope of freedom to operate?

Colchicine is the generic ingredient in nine branded drugs marketed by Par Pharm Inc, Hikma Intl Pharms, Avion Pharms, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Granules, Hetero Labs Ltd V, Mylan, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Sandoz, and Lederle, and is included in twenty-three NDAs. There are twenty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colchicine has three patent family members in two countries.

There are sixteen drug master file entries for colchicine. Twenty-three suppliers are listed for this compound.

Drug Prices for colchicine

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Drug Sales Revenue Trends for colchicine

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Recent Clinical Trials for colchicine

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Wonkwang University HospitalPhase 4
University of CopenhagenPhase 2

See all colchicine clinical trials

Pharmacology for colchicine
Medical Subject Heading (MeSH) Categories for colchicine
Paragraph IV (Patent) Challenges for COLCHICINE
Tradename Dosage Ingredient NDA Submissiondate
GLOPERBA SOLUTION;ORAL colchicine 210942 2020-04-02
COLCRYS TABLET;ORAL colchicine 022352 2019-07-19
MITIGARE CAPSULE;ORAL colchicine 204820 2016-06-10
COLCRYS TABLET;ORAL colchicine 022352 2011-12-23

US Patents and Regulatory Information for colchicine

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Avion Pharms GLOPERBA colchicine SOLUTION;ORAL 210942-001 Jan 30, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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:

Dow
Harvard Business School
Baxter
Boehringer Ingelheim
Johnson and Johnson
Moodys

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