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

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.

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	207621-002	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	207621-003	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	207621-001	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	207621-003	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	207621-002	Aug 19, 2016	8,685,443

International Patents for NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2003270778	SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METOHDS
Australia	2009251081	Sequestering subunit and related compositions and methods
Canada	2499550	SOUS-UNITE DE SEQUESTRATION ET COMPOSITIONS ET PROCEDES ASSOCIES (SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METHODS)
China	1703200	Sequestering subunit and related compositions and methods
Cyprus	1120720
Denmark	1551372

Supplementary Protection Certificates for NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

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	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND 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
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	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	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

Market dynamics and financial trajectory for naltrexone hydrochloride and oxycodone hydrochloride

Last updated: April 26, 2026

How is the market structured for naltrexone hydrochloride?

Naltrexone hydrochloride is an oral opioid antagonist used for alcohol use disorder (AUD) and opioid use disorder (OUD), with product differentiation driven by dose form, label scope, and generic availability.

Where does revenue come from?

• Primary revenue base: chronic AUD and OUD maintenance dosing in outpatient settings, historically dominated by oral naltrexone products.
• Competitive intensity: high due to long-running generic penetration in the U.S., which tends to cap pricing and compress margins.
• Demand drivers: incidence and screening for AUD and OUD, payer coverage, and adherence patterns in long-term maintenance.

Pricing and margin pressure

• Generic substitution increases automatically when multiple ANDA versions exist and prescribers follow payer rules.
• Margin structure in mature oral generics typically depends more on network contracting and manufacturing cost control than on innovation.

How is the market structured for oxycodone hydrochloride?

Oxycodone hydrochloride is a backbone opioid analgesic across acute and chronic pain markets and has broader demand drivers than naltrexone because it sits inside mainstream pain management.

Where does revenue come from?

• Primary revenue base: opioid analgesic utilization in outpatient and inpatient care for pain.
• Competitive intensity: high to very high, with extensive generic competition for many immediate-release and controlled-release strengths.
• Distribution effects: demand is strongly influenced by wholesaler buying patterns, pharmacy formulary status, and insurer constraints.

Regulatory and payer constraints shape volumes

• Oxycodone demand is exposed to:
  • tighter opioid prescribing policies,
  • prior authorization and quantity limits,
  • risk mitigation programs,
  • ongoing enforcement against diversion and overprescribing.
• In practice, these factors often shift utilization from higher volume prescribing toward narrower clinical use and lower prescribing rates.

What does the financial trajectory look like for both drugs in the U.S.?

Both products have a mature, generic-dominated structure, but their revenue paths differ because of clinical positioning and regulatory pressure intensity.

Naltrexone hydrochloride: trajectory profile

• Expected trajectory: stable to modestly growing volumes over time with periodic reimbursement and formulary shifts.
• Key risk: if effective capacity expands faster than covered demand, competition compresses net price faster than volume can offset.
• Key upside: if OUD and AUD treatment uptake rises and payer coverage expands for naltrexone maintenance, volume gains can stabilize net revenue even when pricing falls.

Oxycodone hydrochloride: trajectory profile

• Expected trajectory: flat to declining net pricing, with volume growth limited by opioid stewardship and payer constraints.
• Key risk: further restrictions on opioid prescribing or increased operational scrutiny can reduce total addressable prescriptions.
• Key upside: limited rebounds can occur when pain utilization trends shift or when payer formularies broaden access, but these events are usually constrained by regulation and safety frameworks.

How do generic competition and lifecycle management affect revenues?

Generic-driven outcomes

For both drugs, generic competition affects financial trajectory through:

• net price erosion driven by multiple equivalent manufacturers,
• increased wholesaler and PBM leverage,
• substitution acceleration when pricing differentials widen.

Lifecycle inflection points

Revenue can shift sharply when:

• new generics enter,
• supply disruptions reduce effective competition and lift spot contracting prices,
• formulary decisions reclassify access tiers.

What product formats matter most for market performance?

Naltrexone hydrochloride

• Oral tablet performance depends on:
  • adherence (daily dosing),
  • side-effect tolerance and patient retention,
  • payer coverage and prior auth requirements.

Oxycodone hydrochloride

• Immediate-release vs controlled-release strengths shape demand:
  • controlled-release is more linked to chronic pain patterns,
  • immediate-release is more linked to acute-on-chronic and breakthrough use.
• Abuse-deterrent formulations can influence access, but the market impact depends on payer policies and substitution behavior.

What do real-world contracting and channel dynamics imply?

Wholesale and PBM mechanics

For generics, net revenue tracks closely with:

• contracted discounts,
• rebates and clawbacks,
• bid rotation cycles in pharmacy and institutional formularies.

Institutional vs retail mix

• Retail channel often shows stronger sensitivity to formulary and pharmacy substitution.
• Institutional purchasing can show different timing due to tenders and supply continuity.

What are the likely financial sensitivities by cost and supply?

Manufacturing economics

• Ongoing gross margin in oral generics is sensitive to:
  • API and excipient input costs,
  • yield rates and batch consistency,
  • regulatory compliance costs.
• Supply stability affects negotiated price; shortages can lift net pricing temporarily.

Supply chain and compliance costs

• For oxycodone specifically, operational scrutiny and compliance costs can rise with enforcement intensity and diversion risk controls, affecting cost structure and contract continuity.

How do clinical and safety narratives affect demand?

Naltrexone hydrochloride

• The clinical narrative is treatment-focused for AUD and OUD maintenance.
• Demand tends to follow treatment uptake and integration of substance use disorder care pathways.

Oxycodone hydrochloride

• The demand is constrained by opioid risk mitigation.
• Prescriber behavior shifts with:
  • safer alternative availability,
  • updated guideline emphasis on multimodal analgesia,
  • payer controls and state-level policies.

Competitive landscape implications for business planning

Naltrexone hydrochloride: competitive thesis

• Winning strategy typically centers on contracting reach (PBM access and payer alignment), stable supply, and competitive net pricing.
• Differentiation is limited in a generic market, so execution dominates.

Oxycodone hydrochloride: competitive thesis

• Revenue resilience depends on maintaining channel access under risk controls and ensuring uninterrupted supply.
• Pricing power is structurally limited by generic competition and safety regulation.

Key market scenarios that move financial outcomes

Naltrexone hydrochloride scenarios

• Positive: increased payer coverage for AUD and OUD maintenance, improving covered lives and adherence retention.
• Negative: rapid additional generic entry causing net price compression faster than volumes rise.
• Neutral: stable demand with modest price drift.

Oxycodone hydrochloride scenarios

• Positive: temporary relaxation of access barriers or substitution effects that increase covered utilization.
• Negative: stricter prescribing policies reduce total prescriptions and shift patients to non-opioid or buprenorphine-based care for certain cohorts.
• Neutral: constrained volume with continued net price erosion or stabilization at low levels.

What does this mean for a financial trajectory forecast (directional)?

The directional forecast for a mature market is:

• Naltrexone hydrochloride: revenue trajectory is more likely volume-stable with pricing pressure, yielding modest net revenue movement over time.
• Oxycodone hydrochloride: revenue trajectory is more likely pricing-depressed with volume constrained, yielding flat-to-declining net revenue over the medium term.

Key Takeaways

• Naltrexone hydrochloride is a mature, outpatient-oriented AUD/OUD maintenance product where generic competition caps pricing and coverage-driven volume becomes the main swing factor.
• Oxycodone hydrochloride sits in a high-scrutiny opioid analgesic market where opioid stewardship and payer controls constrain volume and generic competition compresses net price.
• For both, the most material financial sensitivities are net contracting terms (PBM/wholesaler) and supply continuity, not brand-like differentiation.
• Business outcomes hinge on execution in channel access, bid cycles, and manufacturing cost control more than on clinical innovation in the generic era.

FAQs

1) Is naltrexone hydrochloride mainly driven by AUD or OUD?

It is used for both AUD and OUD, with revenue tied to the chronic use pattern for maintenance treatment under payer coverage and adherence.

2) Why does oxycodone hydrochloride face stronger financial headwinds than naltrexone?

Oxycodone demand is directly affected by opioid prescribing restrictions, payer controls, and safety-driven stewardship, which tends to cap prescription volumes even when pain need exists.

3) Do generic entries impact naltrexone and oxycodone the same way?

Both experience net price erosion after additional generic entry, but oxycodone typically shows faster volume sensitivity due to opioid access controls.

4) Which channel usually dominates net revenue for these generics?

Net revenue for mature generics is typically dominated by contracted retail pharmacy and PBM arrangements, with institutional tenders influencing timing and mix.

5) What operational factor most affects near-term earnings in generic markets?

Supply continuity and manufacturing cost per dose, because disruption and compliance-driven downtime can shift negotiated pricing and volumes quickly.

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References

[1] U.S. Food and Drug Administration. “Drugs@FDA.” https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. “Opioids.” https://www.fda.gov/drugs/drug-safety-and-availability/opioids
[3] U.S. Drug Enforcement Administration. “Controlled Substances.” https://www.dea.gov/controlled-substances
[4] Center for Medicare & Medicaid Services (CMS). “Medicaid Drug Rebate Program.” https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/index.html
[5] IQVIA Institute for Human Data Science. “Medicines Use and Spending.” (annual reports). https://www.iqvia.com/insights/the-iqvia-institute/reports