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MITIGARE Drug Profile

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When do Mitigare patents expire, and what generic alternatives are available?

Mitigare is a drug marketed by Hikma Intl Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in MITIGARE is colchicine. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the colchicine profile page.

Summary for MITIGARE

US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	5
Bulk Api Vendors:	66
Patent Applications:	4,344
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MITIGARE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MITIGARE
DailyMed Link:	MITIGARE at DailyMed

Generic Entry Opportunity Date for MITIGARE

NDA:

204820

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for MITIGARE

Mechanism of Action

Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions

Medical Subject Heading (MeSH) Categories for MITIGARE

Gout Suppressants

Tubulin Modulators

US Patents and Regulatory Information for MITIGARE

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		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes

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Paragraph IV (Patent) Challenges for MITIGARE

Drugname	Dosage	Strength	RLD	Date
	Capsules	0.6 mg

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