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Last Updated: August 3, 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, 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-one 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-one suppliers are listed for this compound. There is one tentative approval 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
Wonkwang University HospitalPhase 4
University of CopenhagenPhase 2
Assistance Publique - Hôpitaux de ParisPhase 2

See all colchicine clinical trials

Generic filers with tentative approvals for COLCHICINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free0.6MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Zydus Pharms COLCHICINE colchicine TABLET;ORAL 211519-001 Feb 19, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Zydus Pharms COLCHICINE colchicine TABLET;ORAL 211519-002 Nov 14, 2019 RX No No ⤷  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
>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
Medtronic
Baxter
Mallinckrodt
Express Scripts
AstraZeneca

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