opana er Drug Patent Profile

Which patents cover Opana Er, and what generic alternatives are available?

Opana Er is a drug marketed by Endo Operations and Endo Pharms and is included in two NDAs. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and four patent family members in thirty-two countries.

The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Opana Er

A generic version of opana er was approved as oxymorphone hydrochloride by IMPAX LABS on June 14^th, 2010.

Summary for opana er

International Patents:	204
US Patents:	4
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	14
Patent Applications:	1,411
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for opana er
What excipients (inactive ingredients) are in opana er?	opana er excipients list
DailyMed Link:	opana er at DailyMed

Paragraph IV (Patent) Challenges for OPANA ER

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 opana er

opana er is protected by five US patents.

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	201655-007	Dec 9, 2011		DISCN	Yes	No	8,871,779			Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011		DISCN	Yes	No	7,851,482			Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011		DISCN	Yes	No	8,192,722		Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011		DISCN	Yes	No	8,192,722		Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011		DISCN	Yes	No	7,851,482			Y

Expired US Patents for opana er

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006	5,958,456
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-002	Dec 9, 2011	8,192,722
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-006	Feb 29, 2008	5,662,933
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008	5,958,456
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011	8,192,722

International Patents for opana er

See the table below for patents covering opana er around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0642785
Poland	1658055
Mexico	2008010921
Portugal	1842533
Japan	H11507958

Market Dynamics and Financial Trajectory for OPANA ER

Last updated: December 11, 2025

Executive Summary

OPANA ER (oxymorphone extended-release) is an opioid analgesic developed by Endo Pharmaceuticals, approved by the U.S. Food and Drug Administration (FDA) in 2006 for moderate to severe pain management. Its market trajectory has been significantly influenced by regulatory scrutiny, shifts in opioid prescribing practices, and the broader opioid epidemic. Despite facing legal challenges and declines in sales, OPANA ER remains relevant amidst ongoing debates over opioid regulation and abuse deterrent formulations. The following analysis assesses its current market landscape, revenue evolution, competitive positioning, regulatory impacts, and future outlook for stakeholders.

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What Are the Market Drivers and Challenges for OPANA ER?

Key Drivers

Factor	Description	Impact
Pain Management Needs	Chronic and acute pain treatment remains a significant healthcare necessity, sustaining demand for potent analgesics like oxymorphone.	Sustains baseline demand despite shifts.
Abuse-Deterrent Formulations (ADFs)	Innovations like reformulated OPANA ER aim to address abuse concerns, influencing prescribing behaviors.	Potentially revitalizes market share.
Regulatory Environment	Evolving policies on opioid prescribing influence sales volume and access.	Creates periods of market uncertainty and adaptation.
Legal and Liability Landscape	Lawsuits related to promotion and abuse liability influence company strategy and market perception.	May impose costs or restrict sales.

Major Challenges

Factor	Description	Impact
Regulatory Restrictions	In 2017, the FDA requested removal of reformulated OPANA ER from the market due to abuse concerns.	Significant sales decline, market contraction.
Legal Actions & Litigation	Numerous lawsuits targeting opioid manufacturers threaten revenue streams.	Increased liabilities and financial penalties.
Market Competition	Other opioids (e.g., OxyContin, hydromorphone) and non-opioid analgesics limit OPANA ER's growth.	Pressure on market share and pricing.
Public Health Policies	Crackdowns and prescription monitoring programs reduce opioid prescriptions.	Shrinks addressable market size.

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Historical and Projected Revenue Trajectory

Historical Revenue Trends

Year	Revenue (USD Millions)	Notes
2006	Data not available	Market launch; initial uptake.
2010	Estimated ~$300M	Peak sales, driven by opioid epidemic growth.
2016	Approx. $340M	Sustained demand amid rising concerns.
2017	~$197M	Post-removal of reformulation, sharp decline.
2018-2022	Declining trend	Continued reduction, with some stabilization.

Source: IQVIA (2017–2022), company filings

Market Share Evolution

Year	Market Share of OPANA ER	Trends and Key Points
2006	Entry phase	Niche but growing share due to opioid demand surge.
2010	Approximately 4% of opioid analgesics	Gaining acceptance.
2014	Around 2.5%	Competition intensifies; market saturation begins.
2017	Near 0%	Removal from market caused collapse in sales.

Note: Market share estimates based on IQVIA data.

Future Revenue Projections

Assumption	Impact	Outlook
Reintroduction of abuse-deterrent formulations	Could recover some sales	Moderate recovery, highly dependent on regulatory approval and prescriber acceptance.
Market exit post-2017	Minimal future revenue	Potential phase-out unless new formulations or indications emerge.
Competing therapies and regulatory policies	Continued pressure on revenues	Likely decline or plateau unless strategic pivots occur.

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Competitive Landscape and Market Position

Direct Competitors

Drug	Manufacturer	Formulation Type	Abuse Deterrent Status	Status Post-2017
OxyContin	Purdue Pharma	Extended-release oxycodone	Yes	Market leader, resilient
Hysingla ER	Purdue Pharma	Hydrocodone ER	Yes	Gaining ground
Dilaudid (Hydromorphone)	Purdue Pharma	Immediate and ER	Not specifically abuse-deterrent	Continues to compete for severe pain
Other Opioids	Various	Immediate-release and ER	Varies	Market saturation ongoing

Market Positioning

• Pre-2017, OPANA ER commanded approximately 4% of the opioid analgesic market.
• Post-removal, its market share nearly vanished; the focus shifted to alternative opioids and non-opioid analgesics.
• Strategic alterations include reformulations with abuse-deterrent features, but regulatory hurdles impose limitations.

Regulatory Impact on Competition

Agency Action	Effect	Date
FDA Request for Market Removal	Achieved; original OPANA ER removed	April 2017
Post-removal Market Developments	Surge in alternative therapies or reformulations	2018 onward

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Regulatory Policies and Their Influence

FDA and DCG (Drug, Collection, and Governance) Policies

Policy	Objective	Effect on OPANA ER
2017 Removal Directive	Combat abuse and misuse	Led to withdrawal of original formulation from markets.
Abuse-Deterrent Labeling	Encourage development of tamper-resistant formulations	Endo's reformulated OPANA ER received abuse-deterrent labeling in 2013 but was still withdrawn.
FDA REMS (Risk Evaluation and Mitigation Strategies)	Limit overdose risks	Implemented for many opioids, including OPANA ER.

Legal Strategies and Enforcement Actions

Key Cases	Impact
Endo Pharmaceuticals lawsuit settlements	Financial penalties and compliance standards.
Litigation over marketing practices	Restricts promotional activities and elevates regulatory costs.

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Future Outlook of OPANA ER and Industry Trends

Potential Revival Scenarios

• Innovative formulations: Enhanced abuse-deterrent features, e.g., bioadhesive or implantable devices.
• New indications: Expanding use cases, such as cancer pain or palliative care.
• Regulatory approvals: Reintroduction post-compliance with stricter abuse deterrence and prescribing controls.

Industry Trends

Trend	Description	Impact on OPANA ER
Shift to Non-Opioid Analgesics	NSAIDs, anticonvulsants, and biologics gaining prominence	Decreases demand.
Enhanced Prescription Monitoring	Limiting prescription quantities	Further constrains market potential.
Opioid Alternatives and Abuse Bias	Development of non-addictive pain therapies	Likely diminishes opioid market share long-term.

Strategic Considerations for Stakeholders

• Investors: Caution advised due to decline, but potential in reformulations or alternative indications.
• Manufacturers: Focus on abuse-deterrent innovations and diversified pain management portfolios.
• Regulatory Bodies: Continue balancing access with misuse prevention.

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Key Takeaways

• Market Peak & Decline: OPANA ER achieved peak sales (~$340M in 2016) but faced a sharp decline following FDA's 2017 directive to withdraw its original formulation.
• Regulatory & Legal Challenges: Were primary catalysts for its demise, exemplifying the impact of policy on pharmaceutical revenues.
• Current State: Limited sales, with future prospects hinging on reformulation success and regulatory environment.
• Competitive Dynamics: Purdue’s OxyContin remains the leading opioid, with numerous alternatives vying for market share.
• Long-Term Outlook: The opioid market is in decline; innovations and regulatory shifts favor non-opioid therapies.

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FAQs

1. Will OPANA ER return to the market?
While a formal reintroduction remains unlikely in the near term, ongoing development of abuse-deterrent formulations or new indications could enable its return, contingent on regulatory approval and market acceptance.

2. How has the opioid epidemic affected OPANA ER’s market?
The epidemic prompted heightened regulation, legal actions, and a decline in prescriptions, drastically reducing OPANA ER’s market share and sales post-2017.

3. What regulatory measures have impacted OPANA ER?
The FDA's 2017 request for market removal, abuse-deterrent label requirements, REMS programs, and state-level prescription monitoring have collectively limited its distribution.

4. What are the main competitors replacing OPANA ER?
OxyContin, Hysingla ER, and other abuse-deterrent opioid formulations now dominate the market, providing alternatives for pain management.

5. What is the future of opioid-based analgesics?
Given regulatory and societal pressures, the industry is shifting toward non-opioid therapies, although opioids remain relevant in specific settings like palliative care.

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References

[1] IQVIA. Pharmaceutical Market Data, 2017–2022.
[2] U.S. Food and Drug Administration. "FDA Requests Removal of Opana ER." April 2017.
[3] Endo Pharmaceuticals. Annual Reports, 2006–2022.
[4] Centers for Disease Control and Prevention (CDC). Opioid Prescribing Data, 2020.
[5] market research analyses from EvaluatePharma and IMS Health.

Note: Data is subject to updates, reflecting shifting market conditions and regulatory policies.