OXYMORPHONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for oxymorphone hydrochloride and what is the scope of freedom to operate?

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 three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxymorphone hydrochloride has twenty-eight patent family members in fourteen countries.

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

Summary for OXYMORPHONE HYDROCHLORIDE

International Patents:	28
US Patents:	3
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:	1,975
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
Actavis Elizabeth	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079046-007	Jul 11, 2013		DISCN	No	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-002	Dec 9, 2011		DISCN	Yes	No	8,808,737
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087-006	Jul 22, 2010		RX	No	No
Hikma	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200822-004	Jul 15, 2013		DISCN	No	No
Specgx Llc	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	202321-001	Apr 25, 2013		DISCN	No	No
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006		DISCN	Yes	No	8,871,779			Y
Actavis Elizabeth	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079046-001	Dec 13, 2010		DISCN	No	No

Expired US Patents for OXYMORPHONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011	8,309,060
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011	8,114,383
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008	5,128,143
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008	7,276,250
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011	8,192,722
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-001	Dec 9, 2011	8,075,872
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008	5,958,456

International Patents for OXYMORPHONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2007224221
Russian Federation	2422445	СПОСОБ ПРИГОТОВЛЕНИЯ АНАЛЬГЕТИКОВ (METHOD OF PREPARING ANALGESICS)
European Patent Office	2102213	PROCÉDÉS AMÉLIORÉS DE FABRICATION D'ANALGÉSIQUES (IMPROVED METHOD FOR MAKING ANALGESICS)
Australia	2007331223	Improved method for making analgesics
Mexico	2009006283	METODO MEJORADO PARA PRODUCIR ANALGESICOS. (IMPROVED METHOD FOR MAKING ANALGESICS.)
Japan	2013173765
Japan	5695296

Market Dynamics and Financial Trajectory for Oxymorphone Hydrochloride

Last updated: February 19, 2026

Oxymorphone hydrochloride (HCl) is a potent opioid analgesic indicated for severe pain management. Its market landscape is influenced by regulatory environments, patent status, clinical demand, and societal shifts regarding opioid use.

Market Overview

The global opioid analgesics market, including oxymorphone, was valued at approximately USD 10 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2028, driven by chronic pain treatment needs. Oxymorphone accounts for a small, specialized segment within this market, constrained by market share and regulatory restrictions.

Key Market Drivers

• Increasing pain prevalence: Chronic pain affects over 50 million adults in the U.S., elevating demand for potent opioids.
• Advanced formulations: Development of abuse-deterrent formulations (ADFs) aims to mitigate misuse.
• Expanding elderly population: Aging populations worldwide necessitate potent analgesics, supporting limited growth in specialized opioids.

Regulatory and Legal Environment

• Restricted scheduling: In the U.S., oxymorphone is Schedule II under the Controlled Substances Act, limiting prescribing flexibility.
• DUI and misuse policies: Stricter regulations and prescription monitoring programs decrease misuse but restrict market expansion.
• Global variations: Many countries impose stringent controls or have banned oxymorphone due to abuse concerns, impacting global sales.

Patents and Market Exclusivity

• Patent expiration: The original patent for oxycodone derivatives expired around 2008. Manufacturers now face generic competition.
• Formulation patents: Companies develop ADFs with patent protections extending into the mid-2020s. Such patents influence pricing power and market share.

Competitive Landscape

Major pharmaceutical companies involved in opioids include:

• Purdue Pharma (prior to bankruptcy, developed formulations for oxycodone derivatives).
• Teva Pharmaceuticals.
• Mylan (now part of Viatris).
• Endo Pharmaceuticals.

Generic competition has significantly lowered prices, reducing profit margins for brand-name producers.

Financial Trajectory

• Revenue trends: U.S. sales of oxymorphone peaked near USD 300 million annually in 2010. Sales declined by approximately 60% post-2015 because of increased regulations and societal shifts.
• Market share: Currently, oxymorphone holds less than 2% within the opioid analgesics market, overshadowed by oxycodone and hydrocodone.
• Pricing: Average wholesale price (AWP) for a 10 mg tablet hovers around USD 8-12. Generic competition has pushed prices downward.
• Research & Development: Investment in abuse-deterrent formulations and new delivery systems increases costs but aims to sustain market relevance.

Future Outlook

• Market contraction expected: Due to regulatory pressures and societal decline in opioid prescriptions, revenues are projected to decline further.
• Potential for niche markets: There is limited growth in palliative care or terminal illness scenarios where potent opioids remain essential.
• Emerging risks: Litigation and policy changes, especially in the U.S., may accelerate market exit for some manufacturers.

Summary Table: Key Market Data

Metric	2022 Data	Notes
Market size (global)	USD 10 billion	Opioids segment in total
Oxymorphone revenue	USD 200-300 million	Peak in 2010; declined 60% since 2015
CAGR (2023–2028)	1-2%	Due to declining prescriptions
Price per 10 mg tablet	USD 8-12	Generic pricing
Market share in opioids	<2%	Dominated by oxycodone, hydrocodone

Key Takeaways

1. Market share: Oxymorphone is a limited segment of the global opioids market, with declining sales since their peak in 2010.
2. Regulatory impact: Stricter policies suppress demand and pricing, with many countries imposing bans or restrictions.
3. Patent and competition: Patent expirations for formulations have introduced generics, reducing revenue margins.
4. Future prospects: Market contraction will persist; niche applications remain the only growth avenues.
5. Investment considerations: Limited upside exists; R&D investments focus predominantly on abuse-deterrent technologies.

FAQs

1. Why has oxymorphone hydrochloride’s market declined?
Stringent regulations, societal shifts away from potent opioids, patent expirations, and increased generic competition have caused a significant sales decline.

2. Are new formulations of oxymorphone being developed?
Yes, companies develop abuse-deterrent formulations to address misuse concerns, protected by patents until the mid-2020s.

3. What regions present growth opportunities for oxymorphone?
Few regions, primarily developed countries with strict opioid control, offer growth prospects. Developing markets have imposed bans or severe restrictions.

4. How does regulatory risk impact the market?
High regulatory risks limit prescriber flexibility, restrict supply, and depress prices, causing revenue volatility.

5. What is the outlook for investments in oxymorphone-based drugs?
Investments face declining returns; focus on niche markets or formulations with abuse-deterrent features may offer limited opportunities.

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References

[1] MarketsandMarkets. (2022). Opioid analgesics market analysis.
[2] U.S. Drug Enforcement Administration. (2022). Controlled substances schedules.
[3] IQVIA. (2022). Pharmaceutical market annual review.
[4] FDA. (2020). Guidance on abuse-deterrent opioid formulations.
[5] WHO. (2021). Global pain management report.