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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Questions you can ask:
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Summary for QUTENZA
| International Patents: | 67 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 27 |
| Drug Prices: | Drug price information for QUTENZA |
| What excipients (inactive ingredients) are in QUTENZA? | QUTENZA excipients list |
| DailyMed Link: | QUTENZA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QUTENZA
*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 |
|---|---|
| Nantes University Hospital | Phase 3 |
| Leiden University Medical Center | N/A |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | N/A |
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 |
|---|---|---|---|
| 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.) | ⤷ Sign Up |
| Israel | 181337 | מערכת להעברה תוך עורית המכילה שכבה דביקה, שיטה לציפוי השכבה האחורית של המערכת בסיליקון, ושימוש של שכבה אחורית זו (Transdermal therapeutic system comprising an adhesive layer, method for siliconizing the backing layer of the system and use of said backing layer) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 9930560 | ⤷ Sign Up | |
| European Patent Office | 1039802 | DISPOSITIF THERAPEUTIQUE TRANSDERMIQUE CONTENANT DE LA CAPSAICINE ET SES ANALOGUES (TRANSDERMAL THERAPEUTIC DEVICE WITH CAPSAICIN AND CAPSAICIN ANALOGS) | ⤷ Sign Up |
| South Korea | 101297903 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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