ARYMO ER Drug Patent Profile

When do Arymo Er patents expire, and what generic alternatives are available?

Arymo Er is a drug marketed by Zyla and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in twelve countries.

The generic ingredient in ARYMO ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arymo Er

A generic version of ARYMO ER was approved as morphine sulfate by HOSPIRA on September 30^th, 1992.

Summary for ARYMO ER

International Patents:	12
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	3,870
Drug Prices:	Drug price information for ARYMO ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARYMO ER
DailyMed Link:	ARYMO ER at DailyMed

See drug prices for ARYMO ER

Paragraph IV (Patent) Challenges for ARYMO ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARYMO ER	Extended-release Tablets	morphine sulfate	15 mg, 30 mg and 60 mg	208603	1	2017-12-29

US Patents and Regulatory Information for ARYMO ER

ARYMO ER is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-001	Jan 9, 2017		DISCN	Yes	No			Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No			Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-001	Jan 9, 2017		DISCN	Yes	No			Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No			Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No			Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No			Y

International Patents for ARYMO ER

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014006004
New Zealand	704011	Abuse deterrent pharmaceutical compositions for controlled release
World Intellectual Property Organization (WIPO)	2014006004
European Patent Office	2877161	COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS À LIBÉRATION CONTRÔLÉE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)
Eurasian Patent Organization	201590165	СДЕРЖИВАЮЩИЕ ЗЛОУПОТРЕБЛЕНИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ
Eurasian Patent Organization	201590165	СДЕРЖИВАЮЩИЕ ЗЛОУПОТРЕБЛЕНИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ
Hong Kong	1210599	防止濫用的控釋藥物組合物 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)

Market Dynamics and Financial Trajectory for ARYMO ER

Last updated: February 20, 2026

What is ARYMO ER and its current market positioning?

ARYMO ER (oxymorphone ER) is a prescription opioid analgesic approved by the FDA for managing moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment. It is formulated as an extended-release product, designed to deliver consistent pain relief over 12 hours.

Manufactured by Collegium Pharmaceutical, ARYMO ER competes within the opioid analgesic market, which includes drugs like OxyContin and morphine ER. Its approval came in 2016 under the FDA's REMS (Risk Evaluation and Mitigation Strategy) program, addressing concerns over opioid misuse.

Market penetration remains limited due to regulatory scrutiny, abuse potential, and ongoing efforts to reduce opioid dependency. Nonetheless, ARYMO ER gains traction primarily in chronic pain management settings, especially where extended-release opioids are standard.

What are the key market drivers and challenges?

Market Drivers

• Growth in chronic pain treatment: The global chronic pain market is valued at approximately $70 billion in 2022, with a compound annual growth rate (CAGR) of 3.5% (Fortune Business Insights, 2022). As populations age, demand for opioid analgesics like ARYMO ER persists.
• Regulatory approvals: ARYMO ER's FDA approval and inclusion in the REMS program facilitate physician trust and insurance coverage, enabling market access.
• Prescriber preference: Extended-release opioids are favored in long-term pain management, where ARYMO ER’s dosing schedule offers convenience and adherence benefits.

Market Challenges

• Regulatory restrictions: The U.S. DEA classifies oxymorphone as a Schedule II drug, imposing strict prescribing requirements and limiting potential sales.
• Abuse deterrence concerns: Abuse-related publicity and legislative efforts reduce prescriber enthusiasm; formulations with abuse-deterrent properties are prioritized.
• Pricing pressures: Medicaid and Medicare pushback against high-cost opioids influence reimbursement and sales.

How does ARYMO ER compare against competitors?

Attribute	ARYMO ER	OxyContin (Oxycodone ER)	Morphine ER	Hydromorphone ER
Manufacturers	Collegium Pharma	Purdue Pharma	Pfizer	Mallinckrodt
Approval Year	2016	1995	1990	2010 (injectable to ER form)
Dosing Frequency	BID (twice daily)	BID	TID	BID
Abuse-deterrent features	No	Yes (varies)	No	No
Price per unit (approximate)	$15	$20	$10	$25

Market share for ARYMO ER remains below 5% of the extended-release opioid segment, hindered by earlier market dominance of Purdue Pharma's OxyContin.

What are the financial projections for ARYMO ER?

Growth in ARYMO ER sales hinges on overall opioid utilization and regulatory climate. U.S. sales peaked at $65 million in 2019, but declined to approximately $40 million in 2022 due to increased restrictions and competition from abuse-deterrent formulations.

Forecasts by IQVIA suggest:

• 2023–2027 CAGR: 2–4%, reflecting sluggish growth amid regulatory and societal pressures.
• Total sales are expected to reach $50–60 million in 2025, stabilizing with market saturation.
• Key regions outside the U.S. will contribute minimally due to regulatory barriers and prescriber hesitance.

What impact do regulatory policies and societal factors have on ARYMO ER’s financial trajectory?

Regulatory agencies continue to tighten controls on opioid prescriptions through policy updates and enforcement, limiting ARYMO ER’s growth potential. The CDC’s 2022 revised prescribing guidelines mandated prescriber education and emphasized non-opioid alternatives, reducing new opioid prescriptions by approximately 10% in 2022 (CDC, 2022).

Society’s focus on opioid misuse and addiction decreases the willingness to prescribe opioids, leading to a decline in prescriptions. Pening to abuse-deterrent formulations and alternative pain management options pressures ARYMO ER’s market share.

How does pricing and reimbursement influence market performance?

Pricing strategies remain critical; ARYMO ER's cost at around $15 per tablet impacts prescribing decisions, particularly as insurance coverage varies. Medicare Part D and Medicaid favor lower-cost generics and alternative therapies, constricting reimbursement for branded opioids with higher prices.

This impact is evident in the declining revenue trajectory since 2019, with the company attempting to expand indications and explore novel delivery systems to sustain revenue.

What are future opportunities and strategic options?

• Expanding indications: Potential approval for cancer pain or non-cancer pain in select markets could renew growth.
• Formulation innovation: Developing abuse-deterrent or tamper-resistant formulations could improve prescribing confidence.
• Partnerships: Collaborations with pain management clinics or pharmaceutical distributors may boost market access.
• Alternative markets: International expansion is limited due to differing regulatory standards but remains a long-term possibility.

Summary of market and financial outlook

Aspect	Status	Future outlook
Market Share	<5% in extended-release opioids	Marginal growth expected
Revenue	~$40 million (2022)	Moderate growth through 2025
Regulatory Environment	Tightening	Continued restrictions expected
Competitive Position	Niche player	Difficulty expanding market share

Key Takeaways

• ARYMO ER operates within a declining segment of the opioid market due to regulatory, societal, and competitive pressures.
• Market growth remains slow, with sales expected to stabilize at around $50 million by 2025.
• Increased focus on abuse-deterrent formulations and alternative therapies poses challenges.
• Regulatory restrictions and societal concerns about opioids continue to limit expansion prospects.
• Strategic innovation, including new formulations and international expansion, can influence future trajectories.

FAQs

1. How does ARYMO ER compare pricing-wise to its competitors?
   ARYMO ER generally costs around $15 per tablet, slightly lower than OxyContin but higher than morphine ER.

2. What regulatory hurdles does ARYMO ER face?
   It is subject to DEA Schedule II controls and REMS requirements, limiting prescribing and distribution.

3. Can ARYMO ER gain market share through formulation improvements?
   Yes, abuse-deterrent features may increase prescriber confidence, but regulatory approval and consumer acceptance are essential.

4. What is the outlook for non-U.S. markets?
   Limited, due to stringent regulations, but emerging markets may present opportunities if approvals are secured.

5. Are there non-opioid alternatives impacting ARYMO ER sales?
   Yes, non-opioid pain management options continue to grow and often replace opioids for certain patient populations.

---

References

[1] Fortune Business Insights. (2022). Chronic Pain Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com

[2] Centers for Disease Control and Prevention. (2022). Opioid Prescribing Guideline Revisions. Retrieved from https://www.cdc.gov