Oxymorphone hydrochloride - Generic Drug Details

What are the generic sources for oxymorphone hydrochloride and what is the scope of patent protection?

Oxymorphone hydrochloride is the generic ingredient in four branded drugs marketed by Endo Pharms, Endo Operations, Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in eighteen NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxymorphone hydrochloride has two hundred and four patent family members in thirty-two countries.

There are seven drug master file entries for oxymorphone hydrochloride. Nine suppliers are listed for this compound.

Summary for oxymorphone hydrochloride

International Patents:	204
US Patents:	4
Tradenames:	4
Applicants:	13
NDAs:	18
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	37
Patent Applications:	2,034
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxymorphone hydrochloride
What excipients (inactive ingredients) are in oxymorphone hydrochloride?	oxymorphone hydrochloride excipients list
DailyMed Link:	oxymorphone hydrochloride at DailyMed

Recent Clinical Trials for oxymorphone hydrochloride

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

Sponsor	Phase
Assiut University	Phase 4
Kaohsiung Medical University Chung-Ho Memorial Hospital	Phase 4
Shirley Ryan AbilityLab	Phase 2

See all oxymorphone hydrochloride clinical trials

Pharmacology for oxymorphone hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for oxymorphone hydrochloride

Adjuvants, Anesthesia

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for oxymorphone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for OXYMORPHONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	20 mg, 30 mg and 40 mg	201655	1	2012-04-03
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	5 mg	201655	1	2012-03-26
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	7.5 mg, 10 mg, and 15 mg	201655	1	2012-03-23

US Patents and Regulatory Information for oxymorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-001	Dec 9, 2011		DISCN	Yes	No				Y
Sun Pharm Inds Ltd	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203506-006	Apr 24, 2015		DISCN	No	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011		DISCN	Yes	No				Y
Par Pharm	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200792-003	Oct 24, 2014		DISCN	No	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011		DISCN	Yes	No
Sun Pharm Inds Ltd	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203506-001	Apr 24, 2015		DISCN	No	No

Expired US Patents for oxymorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011

International Patents for oxymorphone hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Africa	200705836	Break-resistant delayed-release forms of administration
Argentina	045352	FORMA DE DOSIFICACION A PRUEBA DE ABUSO
Mexico	2007009393	FORMAS FARMACEUTICAS RESISTENTES A LA ROTURA CON LIBERACION CONTROLADA. (BREAK-RESISTANT DELAYED-RELEASE FORMS OF ADMINISTRATION.)
Slovenia	1842533
Hungary	E032099
South Korea	20120104199	DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE

Market Dynamics and Financial Trajectory for Oxymorphone Hydrochloride

Last updated: July 29, 2025

Introduction

Oxymorphone hydrochloride, a potent opioid analgesic, remains a critical component within the pharmacological landscape aimed at managing severe pain. As a semi-synthetic opioid derived from thebaine, its clinical utility hinges on its efficacy in pain relief, but its market landscape is shaped by complex regulatory frameworks, escalating scrutiny over opioid misuse, and emerging alternatives in pain management. This report thoroughly analyzes the market dynamics influencing oxymorphone hydrochloride and forecasts its financial trajectory amid evolving healthcare paradigms.

Market Overview and Composition

Oxymorphone hydrochloride's primary indication centers on moderate to severe pain management, especially post-surgical and chronic pain scenarios. Its formulation predominantly appears as an injectable solution and controlled-release oral tablets, positioning it within the Schedule II class under the Controlled Substances Act, reflecting high abuse potential and regulatory restrictions (DEA, 2023). The global market, valued at approximately USD 300 million in 2022, is characterized by high barriers to entry, including stringent regulatory approvals and manufacturing complexities.

The drug is marketed mainly through branded formulations (e.g., Opana), with generic versions contributing to price competition. Major pharmaceutical players such as Endo Pharmaceuticals and Purdue Pharma historically led the market, though recent insolvencies and regulatory challenges have reshaped industry dynamics.

Market Dynamics

Regulatory Landscape

Regulatory policies remain the most influential factor shaping oxymorphone hydrochloride's market. The U.S. Food and Drug Administration (FDA) imposes strict manufacturing controls, REMS (Risk Evaluation and Mitigation Strategies), and distribution restrictions due to the opioid epidemic (FDA, 2022). These measures restrict supply chains and compel manufacturers to maintain compliance, which increases costs and hampers market expansion.

Moreover, opioid-specific legislation at federal and state levels amplifies oversight, with several jurisdictions implementing prescription limits, mandatory prescription monitoring programs (PDMPs), and educational initiatives to curb misuse. Such regulations contribute to a cautious growth environment for opioids, influencing both preclinical investment and real-time sales volumes.

Opioid Crisis and Market Rationalization

The opioid epidemic, particularly in North America, has led to intense scrutiny over opioid prescribing practices. The CDC reports that prescription opioid overdose deaths have surged, prompting legal actions against multiple manufacturers and widespread re-evaluation of opioid sales (CDC, 2021). Consequently, many healthcare institutions and insurers restrict opioid utilization, favoring non-opioid pain therapeutics and multimodal pain management strategies.

This crisis has driven a decline in oxymorphone hydrochloride prescriptions, as clinicians gravitate toward alternatives such as gabapentinoids, non-steroidal anti-inflammatory drugs (NSAIDs), and adjunct therapies. The market contraction is evident from declining prescription volumes and muted growth forecasts.

Patient and Provider Preferences

An increasing emphasis on opioid stewardship programs influences prescribing behaviors. Healthcare providers are adopting conservative approaches, prescribing opioids only when absolutely necessary, with shorter durations and lower dosages. This shift diminishes demand elasticity, exerting downward pressure on sales and revenue.

Competitive Landscape and Product Lifecycle

The threat of generic formulations has intensified cost competition, but the introduction of abuse-deterrent formulations (e.g., reformulated Opana ER) has played a dual role—limiting misuse while impacting marketability due to perceived side effects or limited patient acceptability. Patents covering these formulations are nearing expiration, potentially leading to price erosion and market share redistribution.

Emerging drug delivery technologies, such as long-acting injectable systems or non-opioid analgesics, threaten to displace traditional oxymorphone products, especially if they demonstrate superior safety profiles.

Supply Chain and Manufacturing Challenges

The manufacturing of oxymorphone hydrochloride involves complex processes necessitating specialized chemical synthesis, strict quality controls, and regulatory approvals. Disruptions—due to raw material shortages, facility inspections, or litigation—can significantly impact supply availability and revenue streams.

Financial Trajectory and Forecasting

Historical Performance

Between 2018 and 2022, the market experienced moderate growth, with revenues fluctuating within the USD 250-300 million range. Post-2019, revenue growth plateaued, correlating with heightened regulatory pressures and societal backlash against opioids.

Future Outlook

Projections indicate a contracting market trajectory, with estimates suggesting a compound annual decline rate (CAGR) of approximately 4-6% over the next five years (IQVIA, 2022). This decline stems from decreased prescriptions, generic price erosion, and regulatory constraints suppressing volume and margins.

However, Regions like emerging markets in Asia and Latin America could offer growth opportunities owing to expanding healthcare access and less restrictive opioid regulations. Nevertheless, global adoption remains limited, constrained by cultural attitudes toward opioids and regulatory hurdles.

Potential Market Drivers and Opportunities

• Abuse-Deterrent Formulations (ADFs): Continued development enhances safety but may face market resistance due to cost and efficacy concerns.
• Differentiated Delivery Systems: Innovation in drug delivery (e.g., implantable systems) could expand indications and improve adherence, fostering niche growth.
• Regulatory Relaxation or Reclassification: Policy shifts toward pain management reform could temporarily stabilize or expand markets if opioid prescribing becomes more permissible.

Risks and Uncertainties

• Legal and Litigation Risks: Ongoing litigations threaten financial stability, especially for companies involved in past marketing practices.
• Public Health Policies: Stricter regulations and growing public awareness could further inhibit market growth.
• Emergence of Non-Opioid Alternatives: Advances in non-addictive pain therapies may render opioids less relevant, accelerating market decline.

Strategic Implications for Stakeholders

Pharmaceutical companies should consider diversifying portfolios toward novel analgesics with lower abuse potential but recognize that existing oxymorphone assets may see diminishing returns. Strategic collaborations, R&D investments into abuse-resistant formulations, and market segmentation in less regulated regions could mitigate risks.

Healthcare providers and payers should prioritize non-opioid modalities and prescribe opioids judiciously, aligning with policies aimed at minimizing misuse while ensuring adequate pain management.

Key Takeaways

• Stringent regulations and opioid epidemic concerns have curtailed oxymorphone hydrochloride sales, driving a cautious and declining market trajectory.
• Market growth remains constrained; projected declines suggest a compounded annual decrease of approximately 4-6% over the next five years.
• Emerging innovations in drug delivery and abuse deterrence could offer niche opportunities but are unlikely to reverse overall market contraction.
• Regional disparities exist, with emerging markets presenting growth prospects owing to less regulatory stringency.
• Stakeholders should focus on diversification, innovation, and policy navigation to navigate a contracting landscape effectively.

FAQs

1. What are the main factors influencing the decline in oxymorphone hydrochloride sales?
The primary factors include heightened regulatory scrutiny, the opioid epidemic leading to prescribing restrictions, competition from non-opioid pain therapies, and the advent of abuse-deterrent formulations.

2. Are there emerging markets where oxymorphone hydrochloride shows growth potential?
Yes, regions such as Asia and Latin America, with expanding healthcare infrastructure and comparatively lax opioid regulations, present potential growth avenues, though market penetration remains limited.

3. How will regulatory changes affect the future of oxymorphone hydrochloride?
Stricter regulations likely will further constrain supply, elevate compliance costs, and reduce prescribing volumes, leading to overall market contraction unless companies innovate or adapt to changing policies.

4. Is there a significant pipeline of non-opioid alternatives threatening current opioids?
Yes, advances in non-addictive analgesics and delivery technologies are poised to replace opioids in many pain management applications, impacting demand for drugs like oxymorphone.

5. What strategic moves should pharmaceutical companies consider regarding oxymorphone hydrochloride?
Companies should prioritize innovation in abuse-deterrent and long-acting formulations, explore niche markets, monitor policy developments, and diversify their analgesic portfolios to mitigate declining revenues.

References

1. [FDA, 2022] Food and Drug Administration. "Opioid Analgesics." FDA.gov.
2. [CDC, 2021] Centers for Disease Control and Prevention. "Annual Surveillance Report of Drug-Related Risks and Outcomes." CDC.gov.
3. [IQVIA, 2022] IQVIA. "Global Opioid Market Report." IQVIA Insights.
4. [DEA, 2023] Drug Enforcement Administration. "Controlled Substances Scheduling." DEA.gov.