TROXYCA ER Drug Patent Profile

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Which patents cover Troxyca Er, and when can generic versions of Troxyca Er launch?

Troxyca Er is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug.

This drug has sixteen patent family members in twelve countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Troxyca Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 3, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TROXYCA ER

International Patents:	16
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	5
Formulation / Manufacturing:	see details
DailyMed Link:	TROXYCA ER at DailyMed

Drug patent expirations by year for TROXYCA ER

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

Generic Entry Date for TROXYCA ER^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 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.

Anatomical Therapeutic Chemical (ATC) Classes for TROXYCA ER

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for TROXYCA ER

TROXYCA ER is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TROXYCA ER is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TROXYCA ER

Sequestering subunit and related compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Sequestering subunit and related compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for TROXYCA ER

See the table below for patents covering TROXYCA ER around the world.

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Country	Patent Number	Title	Estimated Expiration
Slovenia	1551372		⤷ Try a Trial
Australia	2003270778	SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METOHDS	⤷ Try a Trial
Spain	2677769		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TROXYCA ER

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	LUC00054	Luxembourg	⤷ Try a Trial	PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	SPC/GB17/078	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2316456	132017000142109	Italy	⤷ Try a Trial	PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

Summary for TROXYCA ER

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TROXYCA ER

Anatomical Therapeutic Chemical (ATC) Classes for TROXYCA ER

Patents protecting TROXYCA ER

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