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

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

Generic Entry Date for 022395^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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:	⤷ Subscribe	Patent Expiration:	Sep 6, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Mar 26, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Dec 15, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022395

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	⤷ Subscribe	⤷ Subscribe
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	⤷ Subscribe	⤷ Subscribe
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	⤷ Subscribe	⤷ Subscribe
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	⤷ Subscribe	⤷ Subscribe
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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