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Last Updated: July 4, 2020

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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 Pharms, Mylan, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Watson Labs, Merck, Ani Pharms Inc, Beecham, Impax Labs, Novast Labs, Sandoz, and Lederle, and is included in twenty-one NDAs. There are twenty-four 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. Eighteen 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

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Providence Health & ServicesN/A
Vancouver Coastal HealthN/A
University Hospital, RouenPhase 3

See all COLCHICINE clinical trials

Generic filers with tentative approvals for COLCHICINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.6MGTABLET;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   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
Dr Reddys COLCHICINE colchicine TABLET;ORAL 209876-001 Sep 6, 2019 AB RX No 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:

Express Scripts
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.