Details for New Drug Application (NDA): 022395

✉ Email this page to a colleague

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022395

Generic Entry Date for 022395^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Antipruritics
Sensory System Agents

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:	RX	Dosage:	PATCH;TOPICAL			Strength	8%
Approval Date:	Nov 16, 2009	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 6, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 26, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 15, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022395

Subscribe to access the full database, or Sign Up
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

Complete Access Available with Subscription

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.