Details for New Drug Application (NDA): 207621

NDA 207621 describes TROXYCA ER, which is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TROXYCA ER profile page.

The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.

Summary for 207621

Tradename:	TROXYCA ER
Applicant:	Pfizer
Ingredient:	naltrexone hydrochloride; oxycodone hydrochloride
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 207621

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	1.2MG;10MG
Approval Date:	Aug 19, 2016	TE:		RLD:	No
Patent:		Patent Expiration:	Dec 12, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Jul 3, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	2.4MG;20MG
Approval Date:	Aug 19, 2016	TE:		RLD:	No
Patent:		Patent Expiration:	Dec 12, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

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