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.

Summary for colchicine

International Patents:	3
US Patents:	26
Tradenames:	9
Applicants:	22
NDAs:	25
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	231
Patent Applications:	6,528
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

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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

Sponsor	Phase
NYU School of Medicine	Phase 4
I.M. Sechenov First Moscow State Medical University	Phase 1/Phase 2
Chinese University of Hong Kong	Phase 2

See all colchicine clinical trials

Pharmacology for colchicine

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

Medical Subject Heading (MeSH) Categories for colchicine

Gout Suppressants
Tubulin Modulators

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
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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017156392		See Plans and Pricing
European Patent Office	3426227	COMPOSITION ET MÉTHODE 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.