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QUTENZA Drug Profile

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When do Qutenza patents expire, and when can generic versions of Qutenza launch?

Qutenza is a drug marketed by Averitas and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and one patent family members in twenty-nine countries.

The generic ingredient in QUTENZA is capsaicin. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the capsaicin profile page.

US ANDA Litigation and Generic Entry Outlook for Qutenza

Qutenza was eligible for patent challenges on November 16, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 26, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for QUTENZA

International Patents:	101
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	103
Clinical Trials:	22
Patent Applications:	7,598
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QUTENZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUTENZA
DailyMed Link:	QUTENZA at DailyMed

See drug prices for QUTENZA

Generic Entry Opportunity Date for QUTENZA

NDA:

022395

Dosage:

PATCH;TOPICAL

^*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.

Recent Clinical Trials for QUTENZA

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

Sponsor	Phase
Children's Hospital of Michigan	Phase 1
Grünenthal GmbH	Phase 3
Institut Cancerologie de l'Ouest	Phase 3

See all QUTENZA clinical trials

US Patents and Regulatory Information for QUTENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes			Y
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes			Y
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes			Y
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes			Y

International Patents for QUTENZA

Country	Patent Number	Estimated Expiration
Cyprus	1107582
Denmark	2529732
Spain	2687970
Poland	378806
European Patent Office	1316308
Brazil	PI0515270