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 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. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for colchicine

International Patents:	79
US Patents:	34
Tradenames:	10
Applicants:	24
NDAs:	27
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	248
Patent Applications:	6,926
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

See drug sales revenues for colchicine

Recent Clinical Trials for colchicine

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

Sponsor	Phase
Foundation for Cardiovascular Research Basel	Phase 3
University Hospital, Basel, Switzerland	Phase 3
Fondation Machaon, Switzerland, Genf	Phase 3

See all colchicine clinical trials

Generic filers with tentative approvals for COLCHICINE

Applicant	Application No.	Strength	Dosage Form
		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014	AB	RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014	AB	RX	Yes	Yes
Watson Labs	PROBEN-C	colchicine; probenecid	TABLET;ORAL	085552-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Granules	COLCHICINE	colchicine	TABLET;ORAL	210425-001	Feb 5, 2020	AB	RX	No	No
Watson Labs	COL-PROBENECID	colchicine; probenecid	TABLET;ORAL	084279-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

International Patents for colchicine

Country	Patent Number	Title	Estimated Expiration
Australia	2019201048	Sustained-release formulations of colchicine and methods of using same
Australia	2020294268	Sustained-release formulations of colchicine and methods of using same
Brazil	112015010063	método para o tratamento ou prevenção de um evento cardiovascular em um sujeito com doença vascular aterosclerótica, utilização de um composto de fórmula (i), um derivado da colquicina conhecido e/ou um sal do mesmo, composição para a prevenção ou tratamento de um evento cardiovascular em um sujeito com doença vascular aterosclerótica, método e regime para reduzir ou prevenir a inflamação induzida por cristal de colesterol no interior das placas ateroscleróticas em um sujeito, regime para o tratamento ou prevenção de um acidente cardiovascular em um indivíduo
Slovenia	2914255
Morocco	44940	Traitement ou prévention d'événements cardiovasculaires par administration d'un dérivé de colchicine