Details for New Drug Application (NDA): 207621

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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

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:	7,815,934	Patent Expiration:	Dec 12, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,685,443	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:	7,815,934	Patent Expiration:	Dec 12, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 207621

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016	8,685,443	⤷ Get Started Free
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016	8,685,443	⤷ Get Started Free
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016	8,685,443	⤷ Get Started Free
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016	8,685,443	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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