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Last Updated: March 1, 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.

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
Swiss Heart FoundationPhase 3
Foundation for Cardiovascular Research BaselPhase 3
University Hospital, Basel, SwitzerlandPhase 3

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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
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
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
Agepha Pharma Fz LODOCO colchicine TABLET;ORAL 215727-001 Jun 16, 2023 RX Yes Yes ⤷  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
Hetero Labs Ltd V COLCHICINE colchicine TABLET;ORAL 208993-001 Aug 13, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Agepha Pharma Fz LODOCO colchicine TABLET;ORAL 215727-001 Jun 16, 2023 RX Yes Yes ⤷  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
>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
South Korea 102271048 ⤷  Try a Trial
Mexico 2015014656 FORMULACIONES DE LIBERACION PROLONGADA DE COLCHICINA Y METODOS DE USO DE LAS MISMAS. (SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING SAME.) ⤷  Try a Trial
Eurasian Patent Organization 201990434 ЛЕЧЕНИЕ ИЛИ ПРОФИЛАКТИКА СЕРДЕЧНО-СОСУДИСТЫХ ЯВЛЕНИЙ С ИСПОЛЬЗОВАНИЕМ ПРОИЗВОДНОГО КОЛХИЦИНА ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2014170755 ⤷  Try a Trial
European Patent Office 3964205 TRAITEMENT OU PRÉVENTION D'ÉVÉNEMENTS CARDIOVASCULAIRES (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS) ⤷  Try a Trial
Singapore 11201508571W SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING SAME ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2017156392 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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