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Last Updated: January 27, 2023

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, 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, Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Sandoz, and Lederle, and is included in twenty-five 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-seven 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
NYU School of MedicinePhase 4
I.M. Sechenov First Moscow State Medical UniversityPhase 1/Phase 2
Chinese University of Hong KongPhase 2

See all colchicine clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs PROBENECID W/ COLCHICINE colchicine; probenecid TABLET;ORAL 083221-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms COLCHICINE colchicine TABLET;ORAL 204711-001 Sep 28, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
World Intellectual Property Organization (WIPO) 2017156392 See Plans and Pricing
European Patent Office 3426227 COMPOSITION ET M√ČTHODE D'UTILISATION DE LIQUIDE ORAL DE COLCHICINE (COMPOSITION AND METHOD OF USE OF COLCHICINE ORAL LIQUID) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2019126579 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.