MORPHABOND ER Drug Patent Profile

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

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

This drug has twenty-three patent family members in ten countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Morphabond Er

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

Summary for MORPHABOND ER

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	3,870
Drug Prices:	Drug price information for MORPHABOND ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MORPHABOND ER
DailyMed Link:	MORPHABOND ER at DailyMed

See drug prices for MORPHABOND ER

Paragraph IV (Patent) Challenges for MORPHABOND ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MORPHABOND ER	Extended-release Tablets	morphine sulfate	15 mg, 30 mg, 60 mg and 100 mg	206544	1	2019-01-28

US Patents and Regulatory Information for MORPHABOND ER

MORPHABOND 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
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-001	Oct 2, 2015		DISCN	Yes	No	10,314,788		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-004	Oct 2, 2015		DISCN	Yes	No	7,955,619		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-002	Oct 2, 2015		DISCN	Yes	No	7,955,619		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-004	Oct 2, 2015		DISCN	Yes	No	10,314,788		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-001	Oct 2, 2015		DISCN	Yes	No	7,955,619		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-002	Oct 2, 2015		DISCN	Yes	No	10,314,788		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-003	Oct 2, 2015		DISCN	Yes	No	10,314,788		Y

International Patents for MORPHABOND ER

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2187873	MÉDICAMENTS RÉSISTANT AUX ABUS, PROCÉDÉS D'UTILISATION ET DE FABRICATION (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING)
Mexico	336789	FARMACOS RESISTENTES AL ABUSO, METODO DE USO Y METODO DE FABRICACION. (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING.)
World Intellectual Property Organization (WIPO)	2009023672
Brazil	PI0815387
Canada	2696341
Australia	2015200009
Japan	6608319

Market Dynamics and Financial Trajectory for MORPHABOND ER

Last updated: July 30, 2025

Introduction

MORPHABOND ER—an extended-release formulation of conservative opioid analgesic morphine—occupies a complex niche within the pharmaceutical landscape. As a Schedule II controlled substance, its market dynamics are shaped by regulatory oversight, evolving prescribing practices, and the ongoing opioid crisis. This article provides an in-depth analysis of MORPHABOND ER's market position, competitive landscape, regulatory environment, revenue trajectory, and future prospects, enabling stakeholders to navigate its financial and strategic landscape.

Overview of MORPHABOND ER

MORPHABOND ER is manufactured by Relmada Therapeutics, Inc., designed to provide sustained pain relief through once-daily dosing. It leverages an extended-release (ER) platform to address management of moderate to severe chronic pain. Its patent protection and formulation advantages position it as a potentially significant player in the opioid pain management market, provided it navigates manufacturing, regulatory, and societal hurdles.

Market Dynamics

Regulatory Environment and Prescribing Trends

The global opioid analgesic market is under intense regulatory scrutiny due to the opioid epidemic. The U.S. FDA imposes strict controls over prescribing, manufacturing, and marketing of opioids [1]. Recent regulations focus on reducing overall opioid prescriptions, promoting opioid-sparing strategies, and emphasizing non-opioid alternatives. This tightening impacts new entrants like MORPHABOND ER, whose uptake depends on prescriber safety perceptions, regulatory approvals, and pain management guidelines.

Epidemiology of Chronic Pain

The increasing prevalence of chronic pain—estimated to affect approximately 20% of adults worldwide—drives demand for potent long-acting opioids [2]. Aging populations and rising incidences of conditions such as osteoarthritis and cancer further bolster the need for ER opioid formulations like MORPHABOND ER. However, the shift toward multimodal pain treatment approaches and non-opioid therapies acts as a structural dampener.

Competitive Landscape

Key competitors include Purdue Pharma’s OxyContin, Purdue’s Xtampza ER, Teva’s Kadian, and generic equivalents. Extended-release formulations such as OxyContin (oxycodone ER) have dominated for decades, but prescriber preference is shifting due to safety profiles and abuse-deterrent features. MORPHABOND ER's success hinges on differentiating through safety, bioavailability, and formulational innovations, which are critical in a saturated market.

Societal and Legal Factors

The heightened awareness of opioid misuse, abuse, and diversion impacts marketing and sales strategies. The introduction of abuse-deterrent formulations (ADFs) and tamper-resistant technologies influences market access. Legislation enforcing Prescription Drug Monitoring Programs (PDMPs) reduces overprescription but limits access [3]. Such factors constrain the overall market size but create opportunities for formulations with improved safety profiles.

Financial Trajectory

Revenue Generation and Market Penetration

MORPHABOND ER's commercial success depends on initial market penetration, prescriber acceptance, and insurance reimbursement. As a newer formulation, its revenue trajectory faces a steep startup phase, characterized by limited awareness and formulary negotiations.

Relmada Therapeutics reported early-stage data indicating promising bioequivalence and safety profiles, but actual sales depend on broad formulary inclusion and physician endorsement. Historically, opioid ER formulations exhibit slow adoption trajectories, often spanning several years before achieving significant market share [4].

Pricing and Reimbursement Landscape

Pricing strategies must balance profitability and accessibility amid intense price pressure. Given the opioid crisis, payers and insurers favor cost-effective alternatives and often impose utilization management measures. MORPHABOND ER's pricing must justify its value proposition, possibly through claims of enhanced safety or patient convenience. Reimbursement negotiations can influence revenue, with initial contracts often resulting in conservative coverage until proven formulary stability.

Regulatory Approvals and Patent Landscape

Currently, MORPHABOND ER’s patent portfolio and exclusivity licenses are pivotal to its financial trajectory. Patent protection extends its market exclusivity, delaying generic competition and allowing premium pricing. However, patent challenges and potential biosimilar or generic entrants could erode revenues over time, especially if off-patent formulations gain approval.

Growth Projections

Market forecasts suggest the global opioid analgesic market is poised for growth from USD 15 billion in 2021 to approximately USD 21 billion by 2028, driven predominantly by North American demand [5]. MORPHABOND ER, as part of this ecosystem, may capture a modest share, translating to initial revenues in the low hundreds of millions, with potential for growth contingent on market penetration and safety profile differentiation.

Risks and Opportunities

Key risks include regulatory hurdles, market saturation with generics, shifts toward non-opioid analgesics, and societal initiatives curbing opioid use. Conversely, advances in abuse-deterrent technologies, potential formulation innovations, and expanding indications (e.g., cancer pain, palliative care) offer growth avenues.

Future Outlook

The future of MORPHABOND ER depends on its ability to demonstrate a superior safety profile, obtain regulatory approvals for expanded indications, and integrate into pain management protocols aligned with evolving guidelines. Strategic collaborations with payers and prescribers, coupled with targeted education, are essential for sustained revenue growth.

Key Takeaways

• MORPHABOND ER operates within a highly regulated and scrutinized opioid market, which influences its growth prospects.
• Market dynamics favor innovations emphasizing safety, abuse mitigation, and convenience—areas where MORPHABOND ER can differentiate.
• Revenue trajectory is cautiously optimistic, contingent on successful market penetration, formulary acceptance, and patent protections.
• The societal shift toward opioid stewardship continues to challenge sales but incentivizes formulations with evident safety benefits.
• Strategic positioning, regulatory navigation, and technological differentiation will determine MORPHABOND ER's long-term financial performance.

FAQs

1. What are the primary challenges facing MORPHABOND ER in the current market?
The main obstacles include regulatory restrictions, societal efforts to reduce opioid prescribing, intense competition from established formulations and generics, and reimbursement hurdles.

2. How does MORPHABOND ER differentiate from other extended-release opioids?
Its formulation emphasizes safety and abuse-deterrence—though the specifics are proprietary, features such as tamper-resistant mechanisms and controlled-release technology are major differentiators.

3. What is the expected timeline for MORPHABOND ER to achieve significant market penetration?
Typically, novel opioid formulations can take 3–5 years post-launch to attain substantial market share, contingent upon prescriber acceptance, formulary inclusion, and regulatory support.

4. How does the regulatory environment influence MORPHABOND ER’s financial outcomes?
Stringent oversight and evolving prescribing guidelines may hinder rapid sales growth but also provide a clearer pathway for formulations demonstrating safety, which could favor MORPHABOND ER if it passes regulatory scrutiny.

5. What are the growth prospects for MORPHABOND ER amidst the global shift towards non-opioid analgesics?
While facing headwinds, the drug may carve a niche via safety features and expanded indications, but long-term growth depends on its ability to adapt to the shifting paradigm emphasizing multimodal and non-opioid pain management options.

References

1. FDA Prescription Opioids Overview
2. Global chronic pain prevalence
3. Impact of PDMPs and legislation
4. Market adoption of ER opioids
5. Global opioid analgesics market forecast