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Last Updated: March 29, 2024

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 ten branded drugs marketed by Par Pharm Inc, Hikma Intl Pharms, Scilex Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Granules, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Agepha Pharma Fz, Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Rising, Sandoz, and Lederle, and is included in twenty-seven NDAs. There are thirty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colchicine has seventy-nine patent family members in twenty-five countries.

There are sixteen drug master file entries for colchicine. Thirty-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
Foundation for Cardiovascular Research BaselPhase 3
University Hospital, Basel, SwitzerlandPhase 3
Fondation Machaon, Switzerland, GenfPhase 3

See all colchicine clinical trials

Generic filers with tentative approvals for COLCHICINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.6MG/5MLSOLUTION;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 Strength NDA ANDAs Submitted Submissiondate
GLOPERBA Oral Solution colchicine 0.6 mg/5 mL 210942 1 2020-04-02
COLCRYS Tablets colchicine 0.3 mg 022352 1 2019-07-19
MITIGARE Capsules colchicine 0.6 mg 204820 1 2016-06-10
COLCRYS Tablets colchicine 0.6 mg 022352 1 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
Dr Reddys COLCHICINE colchicine TABLET;ORAL 209876-001 Sep 6, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma COLCHICINE colchicine TABLET;ORAL 209173-001 Mar 10, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for colchicine

Country Patent Number Title Estimated Expiration
European Patent Office 2986280 FORMULATIONS DE COLCHICINE À LIBÉRATION PROLONGÉE ET PROCÉDÉS D'UTILISATION DE CES DERNIÈRES (SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING SAME) ⤷  Try a Trial
Malaysia 198452 SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING SAME ⤷  Try a Trial
Israel 242001 פורמולציות של קולציסין עם שחרור מושהה ושיטות לשימוש בהן (Sustained-release formulations of colchicine and methods of using same) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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