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
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 |


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
Sponsor | Phase |
---|---|
Averitas Pharma, Inc. | Phase 3 |
Institut Claudius Regaud | Phase 2 |
Children's Hospital of Michigan | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for QUTENZA
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 |
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 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |