TROXYCA ER Drug Patent Profile

When do Troxyca Er patents expire, and when can generic versions of Troxyca Er launch?

Troxyca Er is a drug marketed by Pfizer and is included in one NDA. There is one patent 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 December 12, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TROXYCA ER

International Patents:	16
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for TROXYCA ER

TROXYCA ER is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No			Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No			Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016		DISCN	No	No			Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016		DISCN	No	No			Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016		DISCN	No	No			Y

International Patents for TROXYCA ER

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1551372	SOUS-UNITE DE SEQUESTRATION ET COMPOSITIONS ET PROCEDES ASSOCIES (SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METOHDS)
World Intellectual Property Organization (WIPO)	2004026283
Hungary	E038446
European Patent Office	2422775	Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods)
European Patent Office	2422772	Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods)
Portugal	1551372

Supplementary Protection Certificates for TROXYCA ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	SPC/GB17/078	United Kingdom		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	LUC00054	Luxembourg		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	1790064-8	Sweden		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; REG. NO/DATE: EU/1/14/988 20150330
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	2017/059	Ireland		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; REGISTRATION NO/DATE: EU/1/14/988 20150326

Investment Scenario and Fundamentals Analysis for TROXYCA ER

Last updated: February 10, 2026

Overview

TROXYCA ER (oxycodone and tch fentanyl extended-release) is a combination opioid analgesic indicated for managing severe pain. Its market positioning hinges on opioid prescribing trends, regulatory environment, and evolving pain management protocols. The drug's evaluation involves assessing its sales potential, market competition, regulatory hurdles, and intellectual property status.

Market Landscape

TROXYCA ER operates within the opioid analgesic segment, a sector marked by high revenue but increasing regulatory scrutiny due to addiction risks.

• Industry estimate: Global opioid analgesics market was valued at approximately $10.8 billion in 2022, projected to grow at 4-5% annually (Grand View Research).
• Key competitors include brands like OxyContin, Avinza, and Xtampza ER, with market shares influenced by dosing flexibility, abuse-deterrent features, and prescriber preferences.

Regulatory Environment

• Post-2010 legislative changes, encouraged by the CDC guidelines, emphasize caution in opioid prescriptions, favoring abuse-deterrent formulations.
• FDA approval for TROXYCA ER was granted in 2014, with opioid risk evaluation and mitigation strategies (REMS) program enforced.
• Potential for tighter regulations or label updates aimed at reducing abuse could impact sales.

Intellectual Property and Patent Landscape

• Patents protecting TROXYCA ER extend primarily into the late 2020s, with some patents expiring around 2028.
• Patent erosion could lead to generic competition, pressuring prices and margins.
• Opportunities exist in expanding formulation patents or new indications.

Commercial and R&D Fundamentals

• Prescriber acceptance depends on demonstrating abuse-deterrent properties and safety profile.
• Market penetration in high-pain settings (cancer, post-operative) is crucial.
• R&D investments focus on new delivery systems, extended-release formulations, or combination therapies to maintain competitive edge.

Financial Considerations

• Revenue projections hinge on prescriber adoption rates, generic entry timelines, and regulatory developments.
• Cost structures include manufacturing, R&D, legal, and marketing expenses.
• Profit margins could compress with patent expirations and increased competition.

Investment Risks

• Regulatory risk from potential restrictions on opioid prescribing.
• Market risk from competitive products and generic erosion.
• Litigation risk tied to opioid-related lawsuits and public policy changes.

Key Market Trends

• Growing preference for abuse-deterrent formulations.
• Push for non-opioid pain management alternatives.
• Potential for expanded indications reducing reliance on primary market.

Conclusion

TROXYCA ER remains a relevant player in the opioid pain management segment. Its future depends on patent protection, regulatory shifts, prescriber acceptance, and competitive dynamics. Investors should consider the drug’s patent expiration timeline, evolving market trends favoring abuse-deterrent features, and the regulatory climate’s stance on opioids.

Key Takeaways

• The market for opioid analgesics is large but faces increasing regulation and public scrutiny.
• TROXYCA ER benefits from abuse-deterrent features, aligning with current market preferences.
• Patent expiry around 2028 could lead to generic competition, pressuring margins.
• Regulatory policies and litigation risks pose significant investment uncertainties.
• Growth prospects hinge on innovation, expanding indications, and maintaining prescriber confidence.

FAQs

1. How does TROXYCA ER compare with competitors in abuse deterrence?

   • It incorporates abuse-deterrent features aligned with recent regulatory standards, giving it a competitive advantage over non-abuse-deterrent opioids.

2. When are key patents for TROXYCA ER set to expire?

   • Most patents are expected to expire around 2028, after which generic versions may enter the market.

3. What regulatory challenges could impact TROXYCA ER’s sales?

   • Increased restrictions on opioid prescribing, potential label updates, or enhanced REMS requirements could limit sales or prescribing practices.

4. How significant is the generic competition risk?

   • High, given the patent expiration timeline; generic versions could reduce revenue substantially if approved and marketed effectively.

5. Are there opportunities for growth outside the current indications?

   • Yes. Expanding into new pain management indications or formulations could enhance long-term value, pending clinical development and regulatory approval.

Citations

[1] Grand View Research, "Opioid Market to 2028," 2022.
[2] FDA, "TROXYCA ER Approval," 2014.
[3] CDC, "Guidelines for Prescribing Opioids," 2016.
[4] U.S. Patent Office, "Patent Expiry Timeline," 2023.