NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - Generic Drug Details

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

Naloxone hydrochloride; oxycodone hydrochloride is the generic ingredient in one branded drug marketed by Purdue Pharma Lp and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naloxone hydrochloride; oxycodone hydrochloride has one hundred and fifty-one patent family members in forty-one countries.

Summary for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

International Patents:	151
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	57
Patent Applications:	97
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
DailyMed Link:	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

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

Sponsor	Phase
University of North Carolina, Chapel Hill	PHASE4
Henan Cancer Hospital	PHASE4
Yongtao Sun	PHASE4

See all NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE clinical trials

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

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for NALOXONE 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
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y

Expired US Patents for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	7,683,072
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	7,674,799
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014	9,205,082
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014	9,084,729
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	9,205,082
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	9,283,216

International Patents for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Denmark	200700214
Israel	213889	SUSTAINED RELEASE ORAL DOSAGE FORM OF COATED OXYCODONE HYDROCHLORIDE PARTICLES
Croatia	P20150358
Brazil	PI0508758	processo para a preparação de cloridrato de oxicodona tendo menos que 25 ppm de 14 - hidroxicodeinona
Japan	2012188439	PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 ppm 14-HYDROXYCODEINONE
South Korea	20140021716	PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE

Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE

Market Dynamics and Financial Trajectory for Naloxone Hydrochloride and Oxycodone Hydrochloride

Last updated: July 30, 2025

Introduction

The pharmaceutical sector’s landscape for opioids and opioid antagonists such as naloxone hydrochloride and oxycodone hydrochloride is characterized by evolving regulatory environments, shifting public health priorities, and dynamic market forces. These drugs serve distinct yet interconnected roles—naloxone as an opioid overdose reversal agent, and oxycodone as a potent analgesic. Understanding their respective market trajectories involves analyzing recent developments, regulatory influences, demand drivers, and emerging competition.

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Market Overview of Naloxone Hydrochloride

Therapeutic Importance and Market Penetration

Naloxone hydrochloride, an opioid antagonist, is chiefly used to counteract acute opioid overdose, a critical public health issue globally. The global naloxone market has experienced substantial growth, driven by an increasing incidence of opioid overdose deaths, escalating awareness campaigns, and regulatory mandates for naloxone availability in high-risk populations.

The rise in overdose-related fatalities has prompted regulatory bodies like the US FDA and the European Medicines Agency (EMA) to streamline naloxone's approval pathways and endorse broader distribution programs. Notably, the U.S. has authorized the over-the-counter sale of naloxone nasal sprays, catalyzing market expansion—projected to grow at a CAGR of approximately 8-12% through 2027 (Research and Markets, 2022).

Regulatory and Policy Impact

Proactive policies such as standing orders, state-funded distribution programs, and insurance reimbursements have lowered barriers to access. For instance, the FDA approved Narcan (naloxone hydrochloride nasal spray) for OTC sale in 2019, expanding market reach.

Market Challenges and Opportunities

Despite promising growth, challenges include patent expirations of key formulations which invite generic competition, potentially constraining revenues. Conversely, the increased focus on harm reduction and legalization of naloxone distribution programs present significant growth avenues.

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Market Overview of Oxycodone Hydrochloride

Therapeutic Role and Market Size

Oxycodone hydrochloride is a Schedule II opioid analgesic, extensively prescribed for moderate to severe pain. The global oxycodone market is considerable, with North America dominating due to high prescription rates, accounting for over 70% of global sales (IQVIA, 2022).

The market is projected to grow modestly at about 3-5% CAGR over the next five years, influenced by regulatory tightening amid opioid misuse concerns, and the shift towards abuse-deterrent formulations. The rise of alternative pain management therapies and increased scrutiny over opioid prescribing patterns further influence market development.

Regulatory Landscape

Intensified regulation, including prescription tracking programs, dosage limits, and bans on certain formulations, has resulted in decreased sales in some regions. The U.S. DEA’s efforts to curb illicit diversion and abuse have led to tighter controls, impacting revenue streams for traditional oxycodone products.

Innovations and Market Trends

Pharmaceutical companies are investing in abuse-deterrent formulations (ADFs), tamper-resistant pills, and novel delivery methods. Nonetheless, generic oxycodone maintains a competitive price advantage, with generics accounting for the majority of sales.

Risks and Challenges

The ongoing opioid epidemic has heightened regulatory and societal scrutiny, prompting a decline in prescribed volumes and significant legal liabilities for manufacturers involved in opioid production and distribution.

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Comparative Market Dynamics

Demand Drivers

• Naloxone: Driven by public health initiatives, legislative mandates, and increasing overdose fatalities. The rising awareness of opioid overdose risks has resulted in widespread naloxone distribution programs, boosting sales.
• Oxycodone: Traditionally driven by pain management needs, with consumption influenced by medical guidelines, insurance coverage, and physician prescribing patterns. Recent regulatory constraints have subdued growth.

Supply Chain and Production

Generic manufacturing dominates both markets, reducing prices and profitability. Patent expirations for certain proprietary formulations may result in increased generic competition.

Regulatory and Legal Factors

• Naloxone: Supportive policies have expanded accessibility.
• Oxycodone: Stricter regulations and legal challenges have constrained market potential.

Market Penetration and Adoption Patterns

• Naloxone: Increasing adoption in community, law enforcement, and healthcare settings.
• Oxycodone: Usage declining in some regions in favor of non-opioid therapies.

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Financial Trajectory Analysis

Revenue Projections

• Naloxone: The market is anticipated to generate revenues exceeding USD 2.5 billion globally by 2027, primarily driven by OTC formulations and expanded public health programs.
• Oxycodone: Despite the mature market status, revenues are projected to stabilize or decline slightly, estimated to generate over USD 4 billion globally by 2027, influenced by regulatory restrictions and shifts toward alternative treatments.

Profitability Outlook

• Naloxone: Increased demand, coupled with patent expiries on branded products, presents opportunities for generic manufacturers and OTC sales, potentially lowering margins but expanding volume.
• Oxycodone: Profit margins may decline due to legal liabilities, patent expiries, and shift towards abuse-deterrent and generic formulations.

Investment and R&D Trends

• Naloxone: Investment focus remains on novel delivery systems, formulations with longer shelf life, and easy-to-administer devices.
• Oxycodone: R&D is directed toward abuse-deterrent formulations, although growth opportunities are tempered by societal concerns over opioid misuse.

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Strategic Implications for Stakeholders

Pharmaceutical Companies: Focus on expanding access to naloxone through partnerships with public health agencies, and develop next-generation formulations that improve safety profiles. For oxycodone, emphasis on innovation in abuse-deterrent technologies and diversification into non-opioid analgesics is crucial.

Investors: Monitoring policy shifts, patent landscapes, and demographic trends is vital. Increased government funding for overdose prevention underscores a growth trajectory for naloxone, whereas legal risks weigh down oxycodone investments.

Regulators: Continued harmonization of policies around opioid prescribing and overdose management influences market dynamics. Support for harm reduction initiatives characterizes the evolving regulatory landscape.

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Key Takeaways

• The naloxone hydrochloride market is poised for sustained growth owing to increased overdose-related fatalities, legislative support, and expanded access, especially via OTC formulations.
• The oxycodone hydrochloride market faces challenges from regulatory tightening, legal liabilities, and societal pushback against opioids, leading to a potential decline or stabilization in revenues.
• Innovation in formulations, particularly abuse-deterrent technologies, is central to future growth, especially for oxycodone.
• Public health priorities and policy environments significantly influence market trajectories, with naloxone benefiting from harm reduction initiatives and oxycodone experiencing increased regulation.
• Stakeholders should align strategic planning with evolving legal frameworks, demographic trends, and technological advancements to optimize opportunities.

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FAQs

1. What are the key factors driving naloxone's market growth?
   Increasing opioid overdose deaths, public health campaigns, legislative mandates for wider access, and the transition to OTC formulations are primary drivers.

2. How has the regulatory environment impacted oxycodone sales?
   Stricter prescribing guidelines, prescription monitoring programs, and legal actions against manufacturers have led to decreased demand and revenue.

3. What technological advancements are shaping future naloxone formulations?
   Longer shelf life, needle-free devices, nasal sprays with reduced recoil, and instant-activation features are under development.

4. Are generic formulations impacting market margins for both drugs?
   Yes. Patent expirations have introduced generic competition, reducing prices. However, increased volume sales, especially for naloxone, can offset margin pressures.

5. What role do public health policies play in the future of these markets?
   Policies promoting overdose prevention and harm reduction bolster naloxone market growth, while regulatory constraints aim to curb misuse of oxycodone, affecting its market landscape.

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References

[1] Research and Markets. (2022). Global Naloxone Market Report, 2022-2027.
[2] IQVIA. (2022). The Impact of Regulatory Changes on the Global Oxycodone Market.