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. 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.
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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 145 |
| Clinical Trials: | 26 |
| 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 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
| Sponsor | Phase |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | N/A |
| Leiden University Medical Center | N/A |
| Averitas Pharma, Inc. | Phase 3 |
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and kits for the removal of irritating compounds from bodily surfaces
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting QUTENZA
TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN) OF THE FEET
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| China | 1784222 | Therapeutic patch with polysiloxane matrix comprising capsaicin | ⤷ Try a Trial |
| Austria | 344023 | ⤷ Try a Trial | |
| Japan | 2009084289 | COMPOSITION AND KIT FOR REMOVAL OF IRRITATING COMPOUND FROM BODILY SURFACE | ⤷ Try a Trial |
| Hong Kong | 1030853 | ⤷ Try a Trial | |
| Cyprus | 1107582 | ⤷ Try a Trial | |
| Austria | 240723 | ⤷ Try a Trial | |
| Poland | 219512 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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.
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