MORPHINE SULFATE Drug Patent Profile

When do Morphine Sulfate patents expire, and when can generic versions of Morphine Sulfate launch?

Morphine Sulfate is a drug marketed by Actavis Elizabeth, Anda Repository, Impax Labs Inc, Strides Pharma Intl, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms, Chartwell Molecular, Padagis Us, Pharm Assoc, Rhodes Pharms, Sankalp Lifecare, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Alkem Labs Ltd, Ingenus Pharms Nj, and Meridian Medcl Techn. and is included in sixty-two NDAs. There are three patents protecting this drug.

This drug has twenty-four patent family members in eleven countries.

The generic ingredient in MORPHINE SULFATE 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 Morphine Sulfate

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

Summary for MORPHINE SULFATE

International Patents:	24
US Patents:	3
Applicants:	34
NDAs:	62
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	208
Patent Applications:	3,884
Drug Prices:	Drug price information for MORPHINE SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MORPHINE SULFATE
What excipients (inactive ingredients) are in MORPHINE SULFATE?	MORPHINE SULFATE excipients list
DailyMed Link:	MORPHINE SULFATE at DailyMed

See drug prices for MORPHINE SULFATE

See drug sales revenues for MORPHINE SULFATE

Recent Clinical Trials for MORPHINE SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ganesh M. Shankar	PHASE2
Fayoum University Hospital	PHASE4
Khon Kaen University	PHASE4

See all MORPHINE SULFATE clinical trials

Pharmacology for MORPHINE SULFATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for MORPHINE SULFATE

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for MORPHINE SULFATE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for MORPHINE SULFATE

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
ARYMO ER	Extended-release Tablets	morphine sulfate	15 mg, 30 mg and 60 mg	208603	1	2017-12-29
AVINZA	Extended-release Capsules	morphine sulfate	45 mg and 75 mg	021260	1	2009-08-11
AVINZA	Extended-release Capsules	morphine sulfate	30 mg, 60 mg, 90 mg and 120 mg	021260	1	2007-06-04

US Patents and Regulatory Information for MORPHINE SULFATE

MORPHINE SULFATE 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
Fresenius Kabi Usa	MORPHINE SULFATE	morphine sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	204223-001	Oct 30, 2013		RX	Yes	Yes	9,072,781		Y
Pharm Assoc	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	206573-001	Nov 14, 2016	AA	RX	No	No
Hikma	MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	211452-001	Jan 12, 2023	AP	RX	No	No
Teva Pharms Usa	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	202718-005	Dec 29, 2014		DISCN	No	No
Sun Pharm Industries	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	205634-002	Aug 25, 2016		DISCN	No	No
Strides Pharma Intl	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	075295-002	Oct 28, 1998	AB	RX	No	No
Winder Labs Llc	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	211454-001	Feb 12, 2021	AA	RX	No	No

International Patents for MORPHINE SULFATE

See the table below for patents covering MORPHINE SULFATE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2902346	SYSTEME DE CONDITIONNEMENT POUR MEDICAMENTS SENSIBLES A L'OXYGENE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)
Spain	2695158
European Patent Office	2968132	FORMULATION DE MORPHINE INJECTABLE (INJECTABLE MORPHINE FORMULATIONS)
Portugal	2968729
European Patent Office	3143988	FORMULATIONS INJECTABLES À BASE DE MORPHINE (INJECTABLE MORPHINE FORMULATIONS)
Japan	6215970
Australia	2018236914	PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS

Market Dynamics and Financial Trajectory for Morphine Sulfate

Last updated: September 8, 2025

Introduction

Morphine sulfate remains a cornerstone in pain management, particularly for severe acute and chronic pain, owing to its proven efficacy and longstanding clinical use. As a potent opioid analgesic, its market landscape is shaped by complex regulatory, clinical, and societal factors. This report explores the evolving market dynamics, competitive forces, regulatory environment, and financial trajectory of morphine sulfate within the global pharmaceutical landscape.

Market Overview

Morphine sulfate's market is primarily driven by its widespread use in palliative care, perioperative analgesia, and trauma management. Despite the growing emphasis on alternative pain management modalities, it predominantly holds a significant share in opioid analgesic sales globally.

In 2022, the global opioid analgesics market was valued at approximately USD 17 billion, with morphine sulfate constituting about 30% of this segment, reflecting its entrenched position in pain management regimens [[1]].

Regulatory Landscape

Regulatory frameworks significantly influence morphine sulfate's market dynamics. As a controlled substance classified under Schedule II by the US DEA, it faces stringent oversight due to its opioid nature and potential for abuse. Regulatory restrictions impact manufacturing, distribution, prescribing practices, and research activities, often leading to market fluctuations.

Global variations exist—while jurisdictions such as Canada and parts of Europe maintain relatively accessible policies, nations with high abuse concerns impose tighter controls. These diverse regulatory environments create a complex landscape, shaping the supply chain and market access strategies for manufacturers.

Market Drivers

Rising Pain Management Needs

The increasing global prevalence of chronic diseases, cancer, and aging populations drives demand for effective analgesics, with morphine sulfate positioned as a first-line treatment for severe pain [[2]].

Advancements in Formulations

Innovations such as controlled-release formulations enhance patient compliance and safety, broadening morphine sulfate's applicability. Additionally, adjunctive formulations combining morphine with other agents aim to mitigate side effects, expanding market opportunities.

Growing Palliative Care Markets

Enhanced palliative care services, especially in developing regions, boost morphine sulfate utilization, supported by international health initiatives aimed at improving access.

Market Challenges

Opioid Epidemic and Societal Concerns

The opioid crisis, notably in North America, has led to increased scrutiny over opioid prescribing, stringent regulations, and public health campaigns minimizing opioid use [[3]]. These factors threaten to curtail demand and complicate distribution.

Alternative Pain Management Therapies

Non-opioid analgesics and interventional pain management procedures are gaining traction, partially substituting morphine sulfate in certain clinical scenarios.

Supply Chain Disruptions

Regulatory controls, manufacturing complexities, and recent global events like the COVID-19 pandemic have disrupted supply chains, impacting availability and pricing.

Competitive Landscape

Major pharmaceutical companies, including Pfizer, Hospira (a Pfizer subsidiary), and local generics producers, dominate morphine sulfate production. Patents for certain formulations have expired, paving the way for generics and intensifying price competition. The market exhibits high fragmentation, with regional players adapting to local regulatory and market conditions.

Innovative downstream products, such as abuse-deterrent formulations, present new competitive arenas, driven by regulatory concerns and societal pressures.

Financial Trajectory and Forecast

The financial outlook for morphine sulfate is characterized by moderate growth, with projections suggesting a CAGR of approximately 3-5% over the next five years [[4]]. While existing markets in North America and Europe may see slight declines due to regulatory crackdowns, emerging markets in Asia, Africa, and Latin America are poised for growth owing to increasing healthcare access and expanding palliative care programs.

Pricing pressures and market saturation in mature economies may compress margins, especially for generic manufacturers. Conversely, niche formulations and specialty formulations targeting specific patient populations could offset generic market declines.

Additionally, the trend towards integrating digital dispensing and monitoring technologies could influence revenues indirectly by optimizing prescribing behaviors and reducing misuse.

Geographical Market Dynamics

• North America: Largest market segment; growth constrained by regulatory enforcement, but high demand persists due to extensive pain management protocols.
• Europe: Moderate growth with ongoing reforms to balance access and control.
• Asia-Pacific: High growth potential driven by population aging, increasing healthcare infrastructure, and rising cancer incidence.
• Latin America and Africa: Emerging markets with expanding palliative care services and regulatory reforms facilitating increased morphine availability.

Future Outlook and Opportunities

The future of morphine sulfate hinges on balancing effective pain management with societal and regulatory concerns. Potential growth avenues include:

• Developing abuse-deterrent formulations to address misuse issues.
• Expanding access through regulatory reforms, especially in underserved regions.
• Innovating delivery systems (e.g., transdermal patches, injectable long-acting formulations) to improve compliance.
• Leveraging digital health tools for monitoring and optimizing opioid use.

Simultaneously, companies must navigate the evolving regulatory environment carefully, aligning with global best practices to ensure market stability and reputation.

Key Takeaways

• Morphine sulfate maintains a substantial market share in opioid analgesics, with consistent demand driven by severe pain management needs.
• Regulatory controls remain both a safeguard against misuse and a barrier to market expansion, requiring strategic compliance from manufacturers.
• The emergence of generic competition and alternative pain management therapies presents both challenge and opportunity, necessitating innovation and strategic differentiation.
• Expanding access in developing markets presents a promising growth opportunity, supported by international health initiatives.
• Future success hinges on developing abuse-deterrent formulations, expanding delivery options, and aligning with global efforts to balance effective pain relief and societal safety.

FAQs

1. How does the opioid epidemic affect the market for morphine sulfate?
The opioid epidemic has led to stricter prescribing guidelines, tighter regulations, and increased scrutiny, which have constrained market growth in some regions, particularly North America. However, it also incentivizes the development of safer, abuse-deterrent formulations, shaping innovation trajectories.

2. What are the main regulatory challenges for morphine sulfate manufacturers?
Manufacturers face complex licensing requirements, strict distribution controls, and compliance with international and local opioid regulations. These challenges impact supply chains and market access, especially in regions with aggressive controls.

3. Are there emerging markets for morphine sulfate?
Yes. Countries in Asia-Pacific, Africa, and Latin America offer growth prospects due to rising healthcare infrastructure, aging populations, and increasing access to palliative care services.

4. How is innovation influencing the morphine sulfate market?
Innovations such as controlled-release formulations, abuse-deterrent technologies, and alternative delivery systems are driving differentiation and meeting regulatory expectations, potentially expanding market share.

5. What is the outlook for generic versions of morphine sulfate?
Generics dominate pricing and market share, with patent expirations facilitating their entry. Increased competition may pressure prices but also broaden access, especially in emerging markets, contributing to overall volume growth.

References

1. [1] IBISWorld. "Opioid Analgesics Market Report," 2022.
2. [2] WHO. "Cancer Pain Relief: With a Guide to Opioid Availability," 2011.
3. [3] CDC. "Understanding the Epidemic," 2021.
4. [4] Grand View Research. "Opioid Market Analysis and Forecast," 2022.