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Last Updated: May 26, 2022

QUTENZA Drug Patent 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 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

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Drug patent expirations by year for QUTENZA
Drug Prices for QUTENZA

See drug prices for QUTENZA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for QUTENZA
Generic Entry Date for QUTENZA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Averitas Pharma, Inc.Phase 3
Institut Claudius RegaudPhase 2
Children's Hospital of MichiganPhase 1

See all QUTENZA clinical trials

US Patents and Regulatory Information for QUTENZA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QUTENZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING CAPSAICIN IN COMBINATION WITH A GEL COMPOSITION FOR REMOVAL OF CAPSAICIN FROM A TREATMENT AREA OR UNINTENDED AREA

Therapeutic patch for transdermal delivery of capsaicin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING CAPSAICIN IN COMBINATION WITH A GEL COMPOSITION FOR REMOVAL OF CAPSAICIN FROM A TREATMENT AREA OR UNINTENDED AREA

Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting QUTENZA

TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN) OF THE FEET
Exclusivity Expiration: 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
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 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

Patent: 03289710
Estimated Expiration: See Plans and Pricing

Austria

Patent: 3900
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 18250
Estimated Expiration: See Plans and Pricing

Patent: 0318250
Estimated Expiration: See Plans and Pricing

Canada

Patent: 17493
Estimated Expiration: See Plans and Pricing

China

Patent: 84222
Estimated Expiration: See Plans and Pricing

Patent: 0512806
Estimated Expiration: See Plans and Pricing

Patent: 1601664
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 13297
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 13297
Estimated Expiration: See Plans and Pricing

Germany

Patent: 314298
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 90844
Estimated Expiration: See Plans and Pricing

Patent: 36957
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1249
Estimated Expiration: See Plans and Pricing

Japan

Patent: 43657
Estimated Expiration: See Plans and Pricing

Patent: 06514977
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05011012
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1956
Estimated Expiration: See Plans and Pricing

Norway

Patent: 7896
Estimated Expiration: See Plans and Pricing

Patent: 055310
Estimated Expiration: See Plans and Pricing

Poland

Patent: 9512
Estimated Expiration: See Plans and Pricing

Patent: 8806
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 13297
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 49315
Estimated Expiration: See Plans and Pricing

Patent: 05134984
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 13297
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0506462
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1050672
Estimated Expiration: See Plans and Pricing

Patent: 060002997
Estimated Expiration: See Plans and Pricing

Spain

Patent: 88222
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 665
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
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.) See Plans and Pricing
South Korea 101297903 See Plans and Pricing
Brazil PI0515270 sistema terapêutico transdérmico com uma camada adesiva, processo para siliconizar uma camada posterior do sistema e uso da camada posterior See Plans and Pricing
Spain 2634439 See Plans and Pricing
China 1784222 Therapeutic patch with polysiloxane matrix comprising capsaicin 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.