naltrexone hydrochloride; oxycodone hydrochloride - Profile

What are the generic drug sources for naltrexone hydrochloride; oxycodone hydrochloride and what is the scope of patent protection?

Naltrexone hydrochloride; oxycodone hydrochloride is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Naltrexone hydrochloride; oxycodone hydrochloride has sixteen patent family members in twelve countries.

Summary for naltrexone hydrochloride; oxycodone hydrochloride

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for naltrexone hydrochloride; oxycodone hydrochloride

Constraining patent/regulatory exclusivity:

7,815,934

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.

US Patents and Regulatory Information for naltrexone hydrochloride; oxycodone hydrochloride

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	7,815,934		Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016		DISCN	No	No	7,815,934		Y

Expired US Patents for naltrexone hydrochloride; oxycodone hydrochloride

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
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016	8,685,443

International Patents for naltrexone hydrochloride; oxycodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2422775	Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods)
Portugal	1551372
Canada	2499550	SOUS-UNITE DE SEQUESTRATION ET COMPOSITIONS ET PROCEDES ASSOCIES (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)
World Intellectual Property Organization (WIPO)	2004026283
Denmark	1551372

Supplementary Protection Certificates for naltrexone hydrochloride; oxycodone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): 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
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; 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	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	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

Investment Scenario and Fundamentals Analysis for Naltrexone Hydrochloride and Oxycodone Hydrochloride

Last updated: February 9, 2026

What Are the Market Fundamentals for Naltrexone Hydrochloride?

Naltrexone hydrochloride is an opioid antagonist primarily used to treat alcohol dependence and opioid addiction. It is marketed under brands like Revia and Vivitrol.

Market Size & Growth

• Global Market Value (2022): Estimated at $300 million.
• Projected Compound Annual Growth Rate (CAGR): Around 9% through 2030, driven by increasing addiction treatment needs (Source: Markets and Markets).
• Key Markets: U.S. accounts for approximately 70% of sales, with Europe and Asia significant but smaller markets.

R&D and Regulatory Environment

• FDA approvals for extended-release formulations like Vivitrol have expanded treatment options.
• Regulatory hurdles are moderate; no major upcoming patent expirations are forecasted within the next five years, providing pipeline stability.

Competitive Landscape

• Few branded competitors dominate (e.g., Vivitrol); generic versions are emerging, increasing price competition.
• Patent cliff is not imminent; however, formulations and delivery methods are areas of innovation.

Pricing & Reimbursement

• Vivitrol: Wholesale price around $1,150 per injection; reimbursement varies.
• Market growth is sensitive to insurance coverage and government reimbursement policies.

Investment Risks

• Off-label use can limit market expansion.
• New delivery methods or alternative therapies could disrupt existing treatments.

What Are the Fundamentals for Oxycodone Hydrochloride?

Oxycodone hydrochloride is a potent opioid analgesic, used for pain management, marketed as OxyContin, Roxicodone, among others.

Market Size & Growth

• Global Value (2022): Approximately $4.5 billion.
• Growth Rate: Flat or slight decline due to regulatory crackdowns on opioid prescribing and increased awareness of addiction risks.
• Key Markets: U.S. dominates with roughly $3.5 billion in sales; Europe and emerging markets trail significantly.

R&D & Regulatory Trends

• Stricter prescribing guidelines in the U.S. and Europe have reduced new prescriptions.
• Abuse-deterrent formulations are increasingly adopted; these are more expensive but aimed at reducing misuse.

Competitive Environment

• Major players: Purdue Pharma (marketed as OxyContin before bankruptcy), Teva, Mylan.
• The sector faces biosimilar and alternative pain management drug entries, increasing market pressure.

Pricing & Reimbursement

• High retail prices, especially for extended-release products.
• Reimbursement heavily influenced by medical necessity and regulatory controls.

Investment Risks

• Regulatory shifts threaten sales volumes.
• Litigation risks and public health policies aimed at curbing opioid use.

How Do These Drugs Compare for Investment Decisions?

Attribute	Naltrexone Hydrochloride	Oxycodone Hydrochloride
Market Size (2022)	$300M	$4.5B
Growth Rate	9% CAGR	Flat/reducing trend
Key Markets	U.S., Europe	U.S., Europe
Patent Status	No imminent patent expiry	Patent expiries ongoing
Regulatory Environment	Moderate	Stringent and tightening
Reimbursement	Variable, insurance-dependent	Fixed, insurance-driven

Key Challenges and Opportunities

• Volatility in government regulation and public perception impacts both markets.
• Innovation in delivery methods and formulations could extend product lifecycle.
• Emerging markets offer growth potential but face market access and regulatory hurdles.

Key Takeaways

• Naltrexone presents a stable growth opportunity, driven by addiction treatment demand and steady regulatory pathways.
• Oxycodone's market is under increasing pressure from regulation, litigation, and shifts toward alternative pain management options.
• Companies with diversified portfolios and investment in abuse-deterrent technologies are better positioned.
• The regulatory environment's unpredictability requires careful monitoring, especially for opioids.
• Patent management and development pipeline robustness are critical for long-term valuation.

Frequently Asked Questions

1. What are the primary drivers for Naltrexone's growth?
Increasing global opioid addiction rates and expanded licensing for extended-release formulations.

2. How does the patent landscape affect Oxycodone?
Oxycodone faces patent expirations, leading to generic competition and pressure on pricing.

3. Can regulatory changes impact Naltrexone's market share?
Yes. While currently stable, future policy or approval restrictions could influence sales.

4. What is the role of biosimilars or generics for these drugs?
Generics can reduce prices but depend on patent status and regulatory pathways.

5. Are there emerging therapies that threaten these drugs?
Yes. For Oxycodone, non-opioid pain management; for Naltrexone, other addiction therapies such as buprenorphine.

References

1. Markets and Markets. "Opioid Dependence Treatment Market," 2022.
2. IQVIA. "Global Prescription Drug Sales Report," 2022.
3. FDA. "Approval and Regulatory Updates," 2022.
4. IMS Health. "Pain Management Market Overview," 2022.
5. U.S. Patent and Trademark Office. "Patent Status Reports," 2023.