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 Annora Pharma, Aurobindo Pharma Ltd, Endo Operations, Granules, Hikma Intl Pharms, Scilex Pharms, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, 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 thirty NDAs. There are thirty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colchicine has eighty-one patent family members in twenty-five countries.

There are sixteen drug master file entries for colchicine. Thirty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for colchicine

International Patents:	81
US Patents:	36
Tradenames:	10
Applicants:	25
NDAs:	30
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	261
Patent Applications:	7,383
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for colchicine
Drug Sales Revenues:	Drug sales revenues for colchicine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for colchicine
What excipients (inactive ingredients) are in colchicine?	colchicine excipients list
DailyMed Link:	colchicine at DailyMed

See drug prices for colchicine

Drug Sales Revenue Trends for colchicine

See drug sales revenues for colchicine

Recent Clinical Trials for colchicine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 2
University Hospital, Ghent	Phase 3
Belgium Health Care Knowledge Centre	Phase 3

See all colchicine clinical trials

Generic filers with tentative approvals for COLCHICINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.6MG/5ML	SOLUTION;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

Drug Class	Alkaloid
Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions

Medical Subject Heading (MeSH) Categories for colchicine

Gout Suppressants
Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for colchicine

M04AC	Preparations with no effect on uric acid metabolism
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	COLCHICINE	colchicine	TABLET;ORAL	211250-001	Feb 8, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	217030-001	Oct 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	COLCHICINE	colchicine	TABLET;ORAL	204711-001	Sep 28, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Beecham	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	084321-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201501024	СОСТАВЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОЛХИЦИН, И СПОСОБЫ ИХ ПРИМЕНЕНИЯ	⤷ Sign Up
New Zealand	747657	Treatment or prevention of cardiovascular events via the administration of a colchicine derivative	⤷ Sign Up
Mexico	2020009511	TRATAMIENTO O PREVENCIÓN DE EVENTOS CARDIOVASCULARES. (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS VIA THE ADMINISTRATION OF A COLCHICINE DERIVATIVE.)	⤷ Sign Up
Denmark	2914255		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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