QUTENZA Drug Patent Profile

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 eighty-five patent family members in twenty-nine countries.

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

DrugPatentWatch^® 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:	85
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	24
Patent Applications:	3,565
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QUTENZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUTENZA
What excipients (inactive ingredients) are in QUTENZA?	QUTENZA excipients list
DailyMed Link:	QUTENZA at DailyMed

See drug prices for QUTENZA

DrugPatentWatch^® Estimated 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
Averitas Pharma, Inc.	Phase 3
Institut Claudius Regaud	Phase 2
Children's Hospital of Michigan	Phase 1

See all QUTENZA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for QUTENZA

M02AB	Capsaicin and similar agents
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

N01BX	Other local anesthetics
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for QUTENZA

QUTENZA is protected by seven US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QUTENZA

FDA Regulatory Exclusivity protecting 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
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes			Y

Expired US Patents for QUTENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009

International Patents for QUTENZA

When does loss-of-exclusivity occur for QUTENZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QUTENZA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20070053244	TRANSDERMAL THERAPEUTIC SYSTEM COMPRISING AN ADHESIVE LAYER METHOD FOR SILICONIZING THE BACK LAYER OF THE SYSTEM AND USE OF SAID BACK LAYER
European Patent Office	2529732	SYSTEME THERAPEUTIQUE TRANSDERMIQUE AVEC UNE COUCHE ADHESIVE, PROCEDE DE SILICONISE UNE COUCHE SUPPORT DU SYSTÈME ET L'UTILISATION DE LA COUCHE DE SUPPORT. (TRANSDERMAL THERAPEUTIC SYSTEM WITH AN ADHESIVE LAYER, METHOD FOR SILICONIZING A BACKING LAYER OF THE SYSTEM AND USE THE USE OF THE BACKING LAYER.)
South Korea	101297903
Brazil	PI0515270	sistema terapêutico transdérmico com uma camada adesiva, processo para siliconizar uma camada posterior do sistema e uso da camada posterior
Spain	2634439
China	1784222	Therapeutic patch with polysiloxane matrix comprising capsaicin