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Last Updated: July 16, 2024

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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 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
Drug patent expirations by year for QUTENZA
Drug Prices for QUTENZA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Nantes University HospitalPhase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)N/A
Leiden University Medical CenterN/A

See all QUTENZA clinical trials

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

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

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

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.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 200500442 КОМПОЗИЦИИ И НАБОРЫ ДЛЯ УДАЛЕНИЯ РАЗДРАЖАЮЩИХ СОЕДИНЕНИЙ С ПОВЕРХНОСТЕЙ ТЕЛА ⤷  Sign Up
Australia 2005284436 Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer ⤷  Sign Up
Portugal 2529732 ⤷  Sign Up
Portugal 1791533 ⤷  Sign Up
Spain 2196640 ⤷  Sign Up
Japan 4279254 ⤷  Sign Up
Russian Federation 2349315 ТЕРАПЕВТИЧЕСКИЙ ПЛАСТЫРЬ С ПОЛИСИЛОКСАНОВОЙ МАТРИЦЕЙ, СОДЕРЖАЩЕЙ КАПСАИЦИН (THERAPEUTICAL PLASTER WITH POLYSILOXANE MATRIX CONTAINING CAPSAICIN) ⤷  Sign Up
>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.