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. Thirty 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:	11
Patent Applications:	3,492
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	9,549,899		Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No	9,549,899		Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-001	Jan 9, 2017		DISCN	Yes	No	9,044,402		Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No	9,044,402		Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No	9,044,402		Y

International Patents for ARYMO ER

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

Country	Patent Number	Title	Estimated Expiration
China	104684548	Abuse deterrent pharmaceutical compositions for controlled release
Eurasian Patent Organization	201590165	СДЕРЖИВАЮЩИЕ ЗЛОУПОТРЕБЛЕНИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ
Australia	2013285988	Abuse deterrent pharmaceutical compositions for controlled release
Hong Kong	1210599	防止濫用的控釋藥物組合物 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)
South Korea	20150059167	제어된 방출을 위한 남용 제지 약학적 조성물 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)

ARYMO ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARYMO ER

Introduction to ARYMO ER

ARYMO ER (morphine sulfate) is an extended-release (ER) opioid formulation developed by Egalet Corporation, now known as Zyla Life Sciences, with abuse-deterrent properties. It was approved by the U.S. Food and Drug Administration (FDA) on January 9, 2017, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment where alternative treatment options are inadequate[1][3][4].

Market Need and Opportunity

The approval of ARYMO ER came at a time when the need for abuse-deterrent opioids was increasingly recognized due to the growing problem of prescription opioid abuse. The FDA's Opioid Action Plan emphasized the importance of expanding access to abuse-deterrent opioids to discourage misuse and abuse. Given that morphine is one of the most commonly prescribed ER opioids, with nearly 6.4 million prescriptions written in 2016, ARYMO ER filled a significant market gap by offering an abuse-deterrent version of this medication[3][4].

Abuse-Deterrent Technology

ARYMO ER is formulated using Egalet’s proprietary Guardian Technology, which incorporates physical and chemical barriers to deter abuse. This technology makes the tablets resistant to cutting, crushing, grinding, or breaking, and is expected to make abuse by injection difficult. This innovation was a key differentiator in the market, addressing the critical issue of opioid abuse[1][3][4].

Commercial Strategy and Launch

Egalet planned to launch ARYMO ER in the first quarter of 2017, leveraging its established commercial infrastructure. The company divided its sales force into two teams: one focusing on promoting OXAYDO and ARYMO ER to approximately 6,000 healthcare providers, and another team educating about 4,500 healthcare providers on SPRIX Nasal Spray. This targeted approach aimed to build awareness and increase adoption among high-decile pain medicine prescribers[3].

Financial Performance and Revenue

The approval of ARYMO ER triggered a $40 million payment from the second tranche of Egalet’s secured debt financing. In the first quarter of 2019, Egalet reported net product sales of $17.6 million, a significant increase from $6.3 million in the same period of 2018, partly due to the addition of five acquired products. However, the sales and marketing expenses for ARYMO ER decreased due to the discontinuation of its promotion in September 2018[2].

Impact of Discontinuation of Promotion

The decision to discontinue the promotion of ARYMO ER in September 2018 had a notable impact on Egalet's financials. Sales and marketing expenses for ARYMO ER decreased, reflecting the reduced marketing efforts. This shift was part of a broader reorganization strategy, which included focusing on other products and adjusting the company's commercial approach[2].

Reorganization and Name Change

In 2019, Egalet underwent significant reorganization, including a name change to Zyla Life Sciences. This period saw a gain of $114.6 million from reorganization, which included the gain on extinguishment of debt, revaluation of assets and liabilities, and professional fees. The company's net income for the first quarter of 2019 was $96.8 million, a substantial improvement from the net loss of $12.4 million in the same period of 2018[2].

Challenges and Risks

Despite its innovative abuse-deterrent properties, ARYMO ER, like other opioids, carries significant risks of addiction, abuse, and misuse. The product's extended-release formulation increases the risk of overdose and death due to the larger amount of morphine present. These risks necessitate careful management and monitoring by healthcare professionals[1][3].

Regulatory Environment

The FDA's approval of ARYMO ER was part of a broader effort to address opioid abuse through the development and approval of abuse-deterrent products. The regulatory environment continues to evolve, with ongoing reviews and updates to ensure that these products meet stringent safety and efficacy standards[4].

Competitive Landscape

ARYMO ER entered a market dominated by non-abuse-deterrent forms of morphine, with over 98% of ER morphine prescriptions written for these forms in 2016. The introduction of ARYMO ER provided healthcare professionals with an alternative that could help mitigate the risk of abuse, positioning it as a significant player in the opioid market[3].

Future Outlook

The future trajectory for ARYMO ER is influenced by several factors, including the ongoing need for effective pain management solutions, the evolving regulatory landscape, and the company's strategic decisions. While the discontinuation of its promotion has impacted its current market presence, the product's unique features and the company's reorganization efforts suggest potential for future growth and adaptation[2][3].

Key Takeaways

• Innovative Technology: ARYMO ER's abuse-deterrent properties address a critical need in the opioid market.
• Market Opportunity: The product fills a gap in the market for abuse-deterrent morphine formulations.
• Financial Impact: The approval and launch of ARYMO ER had significant financial implications, including triggering debt financing and impacting revenue.
• Regulatory and Safety Considerations: The product is subject to stringent regulatory oversight and carries risks associated with opioid use.
• Competitive Position: ARYMO ER competes in a market where non-abuse-deterrent opioids are prevalent, offering a differentiated solution.

FAQs

Q: What is ARYMO ER, and what is it used for?

ARYMO ER is an extended-release morphine sulfate tablet formulated with abuse-deterrent properties, approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Q: What technology is used in ARYMO ER to deter abuse?

ARYMO ER uses Egalet’s proprietary Guardian Technology, which incorporates physical and chemical barriers to make the tablets resistant to cutting, crushing, grinding, or breaking.

Q: When was ARYMO ER approved by the FDA?

ARYMO ER was approved by the FDA on January 9, 2017.

Q: Why was the promotion of ARYMO ER discontinued?

The promotion of ARYMO ER was discontinued in September 2018 as part of Egalet's broader reorganization strategy and adjustment of its commercial approach.

Q: What are the risks associated with ARYMO ER?

ARYMO ER, like other opioids, carries significant risks of addiction, abuse, and misuse, and its extended-release formulation increases the risk of overdose and death.

Cited Sources

1. Egalet Receives FDA Approval for ARYMO™ ER (morphine sulfate) C-II, an Extended-Release Morphine Product Formulated with Abuse-Deterrent Properties for Treatment of Chronic Pain. PR Newswire, January 9, 2017.
2. Egalet Reports First Quarter 2019 Financial Results and Plan to Change Company Name to Zyla Life Sciences. Biospace, May 16, 2019.
3. United States Securities and Exchange Commission - ARYMO ER. Cloudfront.net.
4. Impact of Exclusivity on Approval of Arymo ER - FDA. FDA, January 9, 2017.