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Last Updated: July 6, 2020

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QUTENZA Drug 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 one hundred and one patent family members in twenty-nine 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.

US ANDA Litigation and 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

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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
Children's Hospital of MichiganPhase 1
Grünenthal GmbHPhase 3
Institut Cancerologie de l'OuestPhase 3

See all QUTENZA clinical trials

US Patents and Regulatory Information for 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   Start Trial   Start Trial   Start Trial
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Merck
Medtronic
Dow
Johnson and Johnson

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.