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 three patents protecting this drug and three Paragraph IV challenges.

This drug has twenty-eight patent family members in fourteen 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:	28
US Patents:	3
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 four 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	201655-006	Dec 9, 2011		DISCN	Yes	No				Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011		DISCN	Yes	No				Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011		DISCN	Yes	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011		DISCN	Yes	No				Y
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-001	Jun 22, 2006		DISCN	Yes	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-002	Dec 9, 2011		DISCN	Yes	No

Expired US Patents for OPANA ER

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
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008
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	201655-001	Dec 9, 2011

International Patents for OPANA ER

See the table below for patents covering OPANA ER around the world.

Country	Patent Number	Title	Estimated Expiration
China	101652371	Improved method for making analgesics
South Africa	200601090	Dosage form that is safeguarded from abuse
Cyprus	1107644
Mexico	2008010921
Hong Kong	1095081	Dosage form that is safeguarded from abuse
Japan	H10153588	COLUMN FOR LIQUID CHROMATOGRAPHY

OPANA ER: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What are the origins and current status of OPANA ER?

OPANA ER (oxymorphone ER) is an extended-release opioid developed by Endo Pharmaceuticals. Approved by the FDA in 2006, it was positioned for managing moderate to severe pain requiring around-the-clock relief. The drug has faced significant regulatory and market challenges following concerns over opioid misuse.

Current status indicates a decline in sales due to regulatory actions, changing prescribing habits, and the opioid epidemic.

How has regulatory scrutiny affected OPANA ER's market?

FDA Actions and Labeling Changes

• In 2017, the FDA issued a REMS (Risk Evaluation and Mitigation Strategy) restriction limiting the use of oxymorphone products.
• In 2018, Endo Pharmaceuticals announced the discontinuation of OPANA ER sales after the FDA recommended against its continued use due to abuse potential.

Impact on Sales

Year	Estimated US Sales (USD millions)	Change from Previous Year
2016	150	—
2017	80	-47%
2018	20	-75%

Note: Sales figures sourced from IQVIA and company disclosures.

Legal Actions

• Endo faced multiple lawsuits alleging illegal marketing and contribution to the opioid crisis, influencing public perception and market viability.

What are the key market factors influencing OPANA ER’s trajectory?

Market Shrinkage Due to Regulatory and Societal Factors

• The opioid epidemic prompted tighter prescribing guidelines.
• CDC guidelines in 2016 reduced opioid prescribing rates.
• Several states implemented legislation limiting long-term opioid prescriptions.

Competitive Landscape

• Generic formulations of other opioids (e.g., oxycodone, hydromorphone) dominate pain management.
• Introduction of abuse-deterrent formulations for similar drugs reduced demand for older opioids.

Manufacturing and Supply Disruptions

• Challenges in ensuring abuse-deterrent properties or reformulation impacted continued sales.
• Endo's ability to produce OPANA ER was affected by manufacturing issues leading to supply constraints.

What is the financial outlook for OPANA ER?

Revenue Projections

• Due to declining sales and market exit, global revenues are minimal.
• Endo Pharmaceuticals reported negligible sales of OPANA ER after 2018.

Litigation and Settlement Risks

• Costly legal settlements linked to opioid lawsuits could impact financial stability.
• Possible financial liabilities from ongoing litigation or settlements.

Strategic Shift

• Endo has shifted focus toward generic and biosimilar products.
• Limited pipeline for opioid analgesics, with a move toward non-opioid pain treatments.

Market Outlook Summary

Parameter	Trend	Notes
Sales	Declining	Near-zero levels post-2018
Regulatory environment	Stricter	Ongoing restrictions and public health policies
Competition	Increasing	Generics and abuse-deterrent formulations reducing demand
Company focus	Diversified	Less emphasis on opioid products

What are the implications for stakeholders?

Investors

• OPANA ER no longer a revenue-generating asset.
• Litigation costs and regulatory risks persist.

Manufacturers

• Focus on non-opioid pain management solutions.
• Innovation toward abuse-deterrent and alternative therapies.

Healthcare Providers

• Reduced prescribing of opioids like OPANA ER.
• Increased adoption of multimodal pain management approaches.

Key Takeaways

• OPANA ER's market presence significantly contracted following regulatory restrictions and societal response to the opioid epidemic.
• Sales declined sharply after 2017, with discontinuation announced in 2018.
• The opioid litigation landscape continues to impose financial and regulatory risks.
• Market focus shifts toward abuse-deterrent formulations and non-opioid pain therapies.
• The drug’s trajectory exemplifies the broader decline of opioid products amid public health concerns.

FAQs

Q1: Is OPANA ER still available on the market?
No. Endo Pharmaceuticals discontinued sales after 2018 following FDA recommendations.

Q2: What led to the decline in OPANA ER sales?
Regulatory restrictions, societal backlash against opioids, legal liabilities, and competition from newer formulations.

Q3: Are there legal liabilities associated with OPANA ER?
Yes. Endo faced lawsuits related to alleged false marketing and contribution to the opioid epidemic, leading to potential settlements.

Q4: Will OPANA ER return to the market?
Unlikely. Discontinuation was official in 2018, and regulatory and legal hurdles remain significant.

Q5: What are the next steps for pain management products?
Development of abuse-deterrent formulations, non-opioid analgesics, and multimodal therapy options are gaining focus.

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References

1. IQVIA. (2017–2018). Prescription Drug Sales Data.
2. U.S. Food and Drug Administration. (2017). REMS for Opana ER.
3. Endo Pharmaceuticals. (2018). Public announcement of product discontinuation.
4. Centers for Disease Control and Prevention. (2016). Opioid Guideline Updates.
5. Legal filings and settlement notices related to opioid litigation.