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QUTENZA Drug Patent Profile

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Which patents cover Qutenza, and what generic alternatives are available?

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

This drug has sixty-seven patent family members in twenty-seven 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.

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.

Indicators of Generic Entry

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Summary for QUTENZA

International Patents:	67
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	26
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QUTENZA
What excipients (inactive ingredients) are in QUTENZA?	QUTENZA excipients list
DailyMed Link:	QUTENZA at DailyMed

Drug patent expirations by year for QUTENZA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QUTENZA

Generic Entry Date for QUTENZA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Leiden University Medical Center	N/A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	N/A
Averitas Pharma, Inc.	Phase 3

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 three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QUTENZA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Therapeutic patch for transdermal delivery of capsaicin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

Expired US Patents for QUTENZA

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

EU/EMA Drug Approvals for QUTENZA

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grunenthal GmbH	Qutenza	capsaicin	EMEA/H/C/000909 Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.	Authorised	no	no	no	2009-05-15
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for QUTENZA

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

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Country	Patent Number	Title	Estimated Expiration
Spain	2288222		⤷ Sign Up
Poland	1791533		⤷ Sign Up
Russian Federation	2398567	ТРАНСДЕРМАЛЬНАЯ ТЕРАПЕВТИЧЕСКАЯ СИСТЕМА С АДГЕЗИОННЫМ СЛОЕМ, СПОСОБ СИЛИКОНИЗАЦИИ СЛОЯ ОСНОВЫ СИСТЕМЫ И ПРИМЕНЕНИЕ СЛОЯ ОСНОВЫ (TRANSDERMAL THERAPEUTIC SYSTEM WITH ADHESION LAYER, METHOD OF SYSTEM SUBSTRATE SILICONISATION AND APPLICATION OF SUBSTRATE)	⤷ Sign Up
Russian Federation	2005134984	ТЕРАПЕВТИЧЕСКИЙ ПЛАСТЫРЬ С ПОЛИСИЛОКСАНОВОЙ МАТРИЦЕЙ, СОДЕРЖАЩЕЙ КАПСАИЦИН	⤷ Sign Up
China	101601664	Therapeutic patch with polysiloxane matrix comprising capsaicin and method for preparing the same	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration