NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for naltrexone hydrochloride; oxycodone hydrochloride and what is the scope of freedom to operate?

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
Clinical Trials:	20
DailyMed Link:	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

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.

Recent Clinical Trials for NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ensysce Biosciences	PHASE1
Quotient Sciences	PHASE1
University of California, Irvine	PHASE2

See all NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

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 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			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	207621-006	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
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

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	207621-001	Aug 19, 2016
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016

International Patents for NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Spain	2677769
European Patent Office	2422773	Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods)
Australia	2003270778	SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METOHDS
Cyprus	1120720
Denmark	1551372
Slovenia	1551372
Hungary	E038446

Supplementary Protection Certificates for NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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	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

NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 14, 2026

Market Dynamics and Financial Trajectory for Naltrexone Hydrochloride and Oxycodone Hydrochloride

Naltrexone Hydrochloride

Market Size and Key Applications

Naltrexone hydrochloride (NTX) is primarily prescribed for alcohol dependence and opioid use disorder (OUD). The global market reached approximately $600 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030, driven by increasing addiction rates and government-funded addiction treatment programs. North America accounts for roughly 75% of sales, leveraging established healthcare infrastructure and high prevalence rates.

Patent and Regulatory Landscape

Existing patents for generic formulations have expired, prompting increased market entry from generic manufacturers. Notable brand-name drugs include Vivitrol (injectable) by Alkermes, FDA-approved since 2006, and Revia (oral), approved since 1994. The injectable form has held a dominant share of approximately 65% in recent years due to better adherence.

Multiple countries have updated regulatory guidelines to expand access, notably the U.S. and Europe, with ongoing trials investigating extended-release and combination formulations.

Market Dynamics

• Competition: The market sees competition primarily from branded products like Vivitrol and orally administered generics. Several companies are exploring sustained-release and implant-based formulations to improve compliance.
• Pricing Trends: Vivitrol's annual cost exceeds $1,000 per dose in the U.S., but price reductions are expected as generics become more prevalent.
• Adoption Drivers: Increased funding for addiction treatment, rising prevalence of substance abuse, and favorable insurance coverage boost market expansion.

Financial Outlook

The sales forecast anticipates steady growth, reaching approximately $800 million by 2030. R&D investments focus on developing novel delivery systems and expanding indications beyond addiction, including obesity and behavioral disorders.

Oxycodone Hydrochloride

Market Size and Key Applications

Oxycodone hydrochloride (OXY) remains a cornerstone analgesic in pain management, with the global market valued at about $4.5 billion in 2022. The market is projected to grow at a CAGR of approximately 3.8% through 2030, driven by rising chronic pain prevalence and aging populations.

Regulatory and Patent Status

Most formulations of oxycodone are generic, with patents expiring globally by 2015-2020. The molecule faces tight regulation due to its high abuse potential, resulting in controlled distribution channels and prescription restrictions.

Brand-name products include OxyContin (extended-release by Purdue Pharma), which remains influential despite legal challenges related to its role in opioid epidemic. Purdue’s patent for OxyContin expired in 2013 in the U.S., leading to widespread generic competition.

Market Dynamics

• Supply Chain and Regulation: The market is influenced by stringent manufacturing and distribution controls aimed at preventing diversion and misuse.
• Pricing Trends: Generic oxycodone prices have decreased post-patent expiration, but formulations with abuse-deterrent properties command premium prices.
• Growth Drivers: The demand for effective pain management fuels ongoing production; however, regulatory crackdowns on opioid prescribing constrain growth.

Financial Outlook

The market is expected to plateau or decline slightly as alternative therapies (e.g., non-opioid analgesics) gain traction and regulatory environments tighten. By 2030, market value may reduce to approximately $4 billion as use shifts toward alternative drugs and restrictions tighten.

Comparative Overview

Attribute	Naltrexone Hydrochloride	Oxycodone Hydrochloride
2022 Market Value	~$600 million	~$4.5 billion
Projected CAGR (2023-2030)	4.5%	3.8%
Main Applications	Alcohol, opioid dependence	Pain management, chronic pain
Patent Status	Multiple generics, older patents expired	Mostly generic, expired patents
Regulatory Environment	Increasing access, expanded indications	Tighted controls; misuse restrictions
Key Drivers	Addiction treatment, new formulations	Pain management needs, aging population

Key Takeaways

• The naltrexone market is steadily expanding due to increased addiction treatments and the development of novel formulations.
• The oxycodone market faces saturation and regulatory challenges; growth prospects depend on the adoption of abuse-deterrent formulations and alternative therapies.
• Generic competition heavily influences pricing and revenue trajectories for both drugs.
• A shift towards non-opioid pain management may restrain growth in oxycodone markets post-2025.
• Public health initiatives and regulatory changes remain pivotal in shaping future market dynamics.

FAQs

Q1: How will regulatory changes impact the naltrexone market?

A1: Expanded access regulations and new formulations could increase demand, but stricter opioid and addiction treatment policies may introduce hurdles for certain delivery systems.

Q2: Are new formulations of oxycodone likely to enter the market?

A2: Yes, but with compliance to abuse-deterrent standards. These formulations command premium pricing but face regulatory scrutiny and market acceptance challenges.

Q3: What is the outlook for patent protection in these markets?

A3: Most patents on original formulations have expired, increasing generic competition and pressuring prices.

Q4: How do public health policies influence these drugs' market trajectories?

A4: Policies aiming to curb opioid abuse may restrict oxycodone access, whereas initiatives for addiction treatment could expand naltrexone use.

Q5: What are the key growth opportunities for pharmaceutical companies?

A5: For naltrexone, developing extended-release and combination therapies; for oxycodone, innovating abuse-resistant formulations while exploring non-opioid alternatives.

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Sources:

[1] MarketWatch. "Naltrexone Market Size, Share & Trends Analysis Report." 2022.

[2] Grand View Research. "Oxycodone Market Analysis." 2022.

[3] FDA Approvals and Patents Database. 2023.

[4] IQVIA. "Global Opioid Market Report." 2022.

[5] ReportLinker. "Addiction Treatment Market Insights." 2022.