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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. 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: | 101 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 115 |
| Clinical Trials: | 23 |
| 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 |
|---|---|
| Institut Claudius Regaud | Phase 2 |
| Children's Hospital of Michigan | Phase 1 |
| Grünenthal GmbH | Phase 3 |
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 | Start Trial | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 200506462 | Start Trial |
| Japan | 4279254 | Start Trial |
| Portugal | 1539124 | Start Trial |
| European Patent Office | 1613297 | Start Trial |
| Canada | 2497771 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
