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
AZ Sint-Jan AV	Phase 3
University Hospital, Ghent	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
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	COLCHICINE	colchicine	CAPSULE;ORAL	215463-001	Apr 29, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	040618-001	May 13, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes	⤷ 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
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	⤷ Sign Up
Mexico	2020012310	FORMULACIONES DE LIBERACION PROLONGADA DE COLCHICINA Y METODOS DE USO DE LAS MISMAS. (SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING SAME.)	⤷ Sign Up
Japan	2015535264	コルヒチン誘導体の投与による心血管イベントの処置または予防	⤷ Sign Up
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.)	⤷ Sign Up
European Patent Office	3964205	TRAITEMENT OU PRÉVENTION D'ÉVÉNEMENTS CARDIOVASCULAIRES (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS)	⤷ Sign Up
China	105307643	Sustained-release formulations of colchicine and methods of using same	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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