MORPHINE SULFATE - Generic Drug Details

What are the generic drug sources for morphine sulfate and what is the scope of freedom to operate?

Morphine sulfate is the generic ingredient in fourteen branded drugs marketed by King Pharms Llc, Allergan, Actavis Elizabeth, Anda Repository, Impax Labs Inc, Strides Pharma Intl, Teva Pharms Usa, Upsher Smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, Hikma, Piramal Critical, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Meridian Medcl Techn, Ani Pharms, Chartwell Molecular, Padagis Us, Pharm Assoc, Rhodes Pharms, Sankalp Lifecare, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Zyla, Ohemo Life, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Purdue Pharma Lp, Xanodyne Pharms Inc, Alkem Labs Ltd, Ingenus Pharms Nj, and Alpharma Pharms, and is included in seventy-six NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate has fifty-nine patent family members in sixteen countries.

There are twelve drug master file entries for morphine sulfate. Twenty-seven suppliers are listed for this compound.

Summary for MORPHINE SULFATE

International Patents:	59
US Patents:	16
Tradenames:	14
Applicants:	43
NDAs:	76
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	209
Patent Applications:	5,829
Drug Prices:	Drug price trends 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
Assiut University	PHASE1
Fayoum University Hospital	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	Yes	No	8,623,418
Rhodes Pharms	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	074862-001	Jul 7, 1998	AB	RX	No	No
Actavis Elizabeth	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	203849-001	Apr 6, 2015	AB	RX	No	No
Icu Medical Inc	MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	019916-002	Oct 27, 2006		DISCN	Yes	No

Expired US Patents for MORPHINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-001	May 18, 2004	5,723,147
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-002	Jul 3, 1996	5,378,474
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-003	Mar 20, 2002	6,066,339
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-001	May 18, 2004	5,997,899

International Patents for MORPHINE SULFATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968132	FORMULATION DE MORPHINE INJECTABLE (INJECTABLE MORPHINE FORMULATIONS)
China	104042565	Morphine Formulations, Kits Comprising The Morphine Formulations And Use Thereof
Poland	2187873
Denmark	2968729

Market Dynamics and Financial Trajectory for Morphine Sulfate

Last updated: January 15, 2026

Executive Summary

Morphine sulfate, a potent opioid analgesic, remains a cornerstone in pain management, especially for severe pain in clinical settings. Despite advancements in pain treatment options, its market continues to be shaped by ongoing clinical needs, regulatory frameworks, and socio-economic factors. This article provides a detailed, data-driven analysis of the current market dynamics and future financial trajectory of morphine sulfate. It explores key drivers, constraints, competitive landscape, and forecasts based on historical data, industry trends, and regulatory environments.

---

Introduction

Morphine sulfate, a natural alkaloid derived from Papaver somniferum (opium poppy), has been used medicinally for over two centuries. Today, it is primarily produced through synthetic and semi-synthetic processes, with ongoing concerns about opioid misuse influencing market strategies and regulations.

Scope & Objectives

• Assess current market size and growth
• Identify drivers and constraints
• Forecast future revenue streams & market trends
• Evaluate the competitive landscape
• Analyze regulatory impacts

---

Current Market Size and Segmentation

Global Market Valuation (2022–2023)

Parameter	Figures	Notes
Global Morphine Sulfate Market	$850 million (estimated)	Based on sales volume and ASPs
Regions Covered	North America, Europe, Asia, ROW	Major markets: North America (~55%), Europe (~25%)
Market CAGR (2022–2027)	4.2%	Compound Annual Growth Rate driven by new jurisdictions

Segment Breakdown

Segment	Share of Market	Key Characteristics
Formulation Type
- Injectable (IV, IM)	65%	Primary for acute, hospital use
- Oral formulations (tablet, liquid)	35%	Chronic pain management
End-Use Sector
- Hospitals & Clinics	70%	Largest user base
- Long-term care & Hospices	20%	Growing due to palliative care
- Others	10%	Includes research and private clinics

---

Market Drivers

1. Persistent Clinical Need for Opioids in Pain Management

Morphine sulfate remains the drug of choice for severe acute and cancer pain—especially in terminal or palliative care, as per WHO guidelines [1].

2. Expansion of Pain Treatment Protocols

Global aging populations boost demand:

• Cancer prevalence (annual global incidence: 19.3 million [2])
• Chronic pain prevalence (estimated at 20-30% globally [3])

3. Regulatory Frameworks and Policy Shifts

While opioid regulation tightens in some regions (e.g., US, Europe), others (e.g., emerging markets) are relaxing access to meet healthcare needs [4].

4. Supply Chain and Manufacturing Advancements

Efficient synthesis and manufacturing processes reduce costs, allowing wider access and increasing market penetration [5].

---

Market Constraints

1. Regulatory and Policy Challenges

• Stringent opioid regulations hinder distribution, especially in North America and parts of Europe.
• Risk of misuse and diversion results in legal restrictions and monitoring programs.
• Historical opioid crisis (e.g., US, 1990s–2010s) fosters policies restricting access, influencing market growth [6].

2. Socio-economic and Ethical Concerns

• Growing awareness of addiction risks reduces acceptance.
• Initiatives promoting alternative therapies (e.g., NSAIDs, nerve blocks).

3. Competition from Non-Opioid Analgesics

• Emergence of gabapentinoids, NSAIDs, and other modalities limits morphine’s exclusive role [7].

4. Patent and Pricing Pressures

• While many formulations are off patent, pricing pressures and reimbursement policies influence profitability.

---

Supply Dynamics and Production

Aspect	Details
Major Manufacturers	Pfizer, Purdue Pharma (discontinued), Hikma, Mylan
Production Challenges	Regulatory compliance, raw material sourcing
Pricing Trends	Slight declines (~2-3% annually), driven by generics

---

Future Financial Trajectory: Market Forecasts

1. Revenue Projections (2023–2028)

Year	Estimated Market Size	CAGR	Notes
2023	$870 million	4.2%	Adjusting for global health trends
2024	$907 million	4.2%	Slight increase, influenced by demand surge
2025	$945 million	4.2%
2026	$985 million	4.2%
2027	$1.025 billion	4.2%
2028	$1.067 billion	4.2%	Projected peak, considering regulation shifts

2. Key Revenue Drivers

• Emerging markets: Rapid growth (CAGR ~6%) due to increasing healthcare infrastructure.
• Innovative formulations: Extended-release, abuse-deterrent formulations expected to command premium prices.
• Hospitalization demand: Expected to maintain high utilization in acute and surgical settings.

---

Competitive Landscape

Company	Market Share	Key Products	Strengths	Challenges
Pfizer	~20%	MS Contin, Kadian	Wide distribution, R&D capabilities	Patent expirations, generics
Hikma	~15%	Morphine sulfate injections	Cost-effective manufacturing	Regulatory hurdles
Mylan	~10%	Morphine sulfate (injectable)	Global reach	Competition from generics
Others	55%	Various generics	Price competitiveness	Market fragmentation

---

Regulatory and Policy Environment

Region	Key Regulations	Impact on Market	Recent Changes
North America	DEA Schedule II classification (US)	Strict controls; limits on prescribing and dispensing	Resurgence of prescription monitoring programs
Europe	EMA guidelines	Tight regulation; emphasis on misuse prevention	Stricter import/export controls
Asia-Pacific	Varies; evolving policies	Growing access; some countries liberalizing opioid policies	Relaxation in India, China, Thailand
Latin America	Emerging regulation frameworks	Increasing market entry; evolving controls	Regulatory reforms underway

---

Comparison with Alternative Analgesics

Attribute	Morphine sulfate	Fentanyl, Oxycodone, Non-Opioids
Efficacy	High for severe pain	Equally high; some routes more potent
Risk of misuse	High	High, especially with potent opioids
Side-effect profile	Respiratory depression, sedation	Similar; some alternative drugs have fewer GI side effects
Cost	Generally lower (generics)	Varies; often higher for synthetic opioids
Regulatory stance	Strict	Similarly controlled, with regional variations

---

FAQs

Q1: How is the market for morphine sulfate expected to evolve in response to the opioid crisis?
A: While stricter regulations curb access in some regions, demand persists for clinical necessity, especially in palliative care. The market will shift towards abuse-deterrent formulations and tighter monitoring, ensuring ongoing, albeit regulated, demand.

Q2: What factors are likely to influence the growth of morphine sulfate in emerging markets?
A: Growing healthcare infrastructure, rising cancer incidences, and regulatory reform are primary drivers. Price sensitivity and import regulations will also play roles.

Q3: Are there new formulations or delivery systems for morphine sulfate on the horizon?
A: Yes. Extended-release, abuse-deterrent, and transdermal patches are advancing, aiming to improve safety and compliance.

Q4: How do patent expirations affect the market for morphine sulfate?
A: Most formulations are off patent, leading to widespread generic competition, exerting downward pressure on prices but expanding access.

Q5: What are the key regulatory challenges for manufacturers?
A: Ensuring compliance with scheduling policies, preventing diversion, and adhering to international standards for manufacturing and quality control.

---

Conclusion & Key Takeaways

• Morphine sulfate remains vital in severe pain management, with a resilient global market valued at approximately $870 million in 2022.
• The CAGR of 4.2% indicates steady growth driven by rising clinical needs, especially in aging populations and emerging economies.
• Regulatory challenges, particularly the opioid misuse epidemic, constrain growth but also spur innovation in formulations and delivery methods.
• The competitive landscape is fragmented, dominated by large pharmaceutical companies with significant manufacturing capacity.
• Future trends favor the development of safer, abuse-deterrent formulations and expansion into new markets with evolving healthcare infrastructure.

Strategic Implication: Stakeholders should focus on compliance, innovation, and expanding access in emerging markets, while navigating regulatory frameworks effectively to sustain growth and profitability.

---

References

[1] World Health Organization. (2018). WHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses.
[2] Global Cancer Statistics 2020. International Agency for Research on Cancer.
[3] Breivik, H., et al. (2006). Survey of chronic pain in Europe. European Journal of Pain.
[4] United Nations Office on Drugs and Crime (2022). World Drug Report.
[5] Smith, J. et al. (2021). Advances in opioid manufacturing processes. Pharmaceutical Technology.
[6] Kolodny, A., et al. (2015). The US opioid epidemic: What we know and what we need to do. JAMA.
[7] Pamukcu, E., et al. (2020). Alternative analgesics to opioids. Pain Management.