COLCHICINE - Generic Drug Details

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-three patent family members in twenty-five countries.

There are sixteen drug master file entries for colchicine. Thirty-four suppliers are listed for this compound.

Summary for COLCHICINE

International Patents:	83
US Patents:	36
Tradenames:	10
Applicants:	25
NDAs:	30
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	261
Patent Applications:	6,739
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

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942-001	Jan 30, 2019		RX	Yes	Yes			Y
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No

International Patents for COLCHICINE

Country	Patent Number	Title	Estimated Expiration
Canada	2909370	FORMULATIONS DE COLCHICINE A LIBERATION PROLONGEE ET PROCEDES D'UTILISATION DE CES DERNIERES (SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING SAME)
Israel	238519	טיפול או מניעה של אירועים של הלב וכלי-הדם באמצעות מתן של נגזרת של קולכיצין (Treatment or prevention of cardiovascular events via the administration of a colchicine derivative)
Mexico	2015005637	TRATAMIENTO O PREVENCIÓN DE EVENTOS CARDIOVASCULARES MEDIANTE LA ADMINISTRACIÓN DE UN DERIVADO DE COLCHICINA. (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS VIA THE ADMINISTRATION OF A COLCHICINE DERIVATIVE.)