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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 022395


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NDA 022395 describes QUTENZA, which is a drug marketed by Averitas and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the QUTENZA profile page.

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.
Summary for 022395
Tradename:QUTENZA
Applicant:Averitas
Ingredient:capsaicin
Patents:3
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022395
Generic Entry Date for 022395*:
Constraining patent/regulatory exclusivity:
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.

Medical Subject Heading (MeSH) Categories for 022395
Suppliers and Packaging for NDA: 022395
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUTENZA capsaicin PATCH;TOPICAL 022395 NDA Averitas Pharma Inc 72512-928 72512-928-01 1 KIT in 1 CARTON (72512-928-01) * 1 POUCH in 1 CARTON (72512-920-00) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE
QUTENZA capsaicin PATCH;TOPICAL 022395 NDA Averitas Pharma Inc 72512-929 72512-929-01 1 KIT in 1 CARTON (72512-929-01) * 2 POUCH in 1 CARTON (72512-920-01) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength8%
Approval Date:Nov 16, 2009TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 6, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Mar 26, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 15, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022395

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
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 ⤷  Try a Trial ⤷  Try a Trial
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 ⤷  Try a Trial ⤷  Try a Trial
Averitas QUTENZA capsaicin PATCH;TOPICAL 022395-001 Nov 16, 2009 ⤷  Try a Trial ⤷  Try a Trial
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

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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.