Morphine sulfate - Generic Drug Details

What are the generic 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, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, 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, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, 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. Thirty 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:	30
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	199
Patent Applications:	6,641
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
Canadian Institutes of Health Research (CIHR)	Phase 3
University of Calgary	Phase 3
Instituto Nacional de Cancer, Brazil	Phase 2

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	022321-003	Aug 13, 2009		DISCN	Yes	No			Y
Nortec Dev Assoc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	203158-003	Aug 4, 2021		DISCN	No	No
Specgx Llc	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	076412-002	Jul 31, 2003	AB	RX	No	No
Specgx Llc	MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	020631-002	Jul 3, 1996		DISCN	No	No
Specgx Llc	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	076438-001	Jul 3, 2003	AB	RX	No	No
Strides Pharma	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	200812-005	Nov 10, 2011		DISCN	No	No
Vistapharm	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	201947-001	Jan 5, 2012		DISCN	No	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	021671-003	May 18, 2004
Purdue Pharma Lp	MS CONTIN	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	019516-002	Apr 8, 1988
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-002	May 18, 2004
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-001	May 18, 2004
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-008	Apr 20, 2007
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-002	May 18, 2004

International Patents for morphine sulfate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010019279
Japan	2016512210	注射可能なモルヒネ製剤
Canada	2734075	COMPOSITIONS PHARMACEUTIQUES CONFIGUREES POUR DISSUADER LE FRACTIONNEMENT DES FORMES POSOLOGIQUES (PHARMACEUTICAL COMPOSITIONS CONFIGURED TO DETER DOSAGE FORM SPLITTING)
Poland	2187873
Mexico	2010001812	FARMACOS RESISTENTES AL ABUSO, METODO DE USO Y METODO DE FABRICACION. (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING.)
European Patent Office	3143988	FORMULATIONS INJECTABLES À BASE DE MORPHINE (INJECTABLE MORPHINE FORMULATIONS)
China	104684548	Abuse deterrent pharmaceutical compositions for controlled release

Morphine sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Morphine Sulfate

Market Overview

The global morphine sulfate market is experiencing a significant growth phase, driven by several key factors. As of 2023, the market size is estimated to be worth USD 23.6 billion and is forecasted to reach USD 49.1 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 7.6% during the period from 2024 to 2033[1].

Drivers of Market Growth

Rising Incidence of Chronic Pain

One of the primary drivers of the morphine sulfate market is the increasing incidence of chronic pain conditions such as cancer, post-surgery recovery, and other medical concerns. Morphine, with its potent analgesic properties, remains a preferred choice among healthcare providers for managing these conditions, thus fueling market expansion[1].

Aging Population

The global demographic landscape is witnessing an aging population trend, which puts increased strain on older individuals due to chronic diseases and pain-related conditions. This demographic shift is a significant driver for the medical morphine market, as the demand for effective pain management solutions increases[1].

Increasing Healthcare Expenditure

Rising healthcare expenditure and a growing focus on healthcare are projected to boost the demand for morphine sulfate. The increasing prevalence of chronic diseases, such as arthritis, cardiovascular issues, and cancer, further bolsters the demand for pain management solutions like morphine sulfate[4].

Market Segments

Route of Administration

The market is segmented based on the route of administration, with parenteral administration (injecting morphine directly into the bloodstream) dominating the market with a 45.8% market share. Other routes include oral and other forms of administration[1].

Application

The application segment is led by the cancer segment, which accounts for 42.2% of the market share in 2023. Other significant applications include arthritis, myocardial infarction, kidney stones, and diarrhea[1].

Distribution Channel

Hospital pharmacies play a crucial role in providing instantaneous pain relief in clinical settings, holding a 39% market share. Retail and online pharmacies also contribute to the market distribution[1].

Regional Analysis

North America

North America asserts its dominance in the market with a commanding 52.3% share, amounting to a widespread market income of USD 12.3 billion. The region's developed healthcare infrastructure and high prevalence of chronic diseases are key factors driving this dominance[1].

Asia Pacific

The Asia Pacific region is expected to see high growth over the forecast period due to the rising focus on healthcare and the increasing prevalence of chronic diseases. This region is anticipated to contribute significantly to the global morphine sulfate market[4].

Key Players and Strategic Initiatives

Prominent market players are investing substantially in research and development to broaden their product range. These strategic moves include the introduction of new products, contractual partnerships, mergers and acquisitions, and collaborative ventures. These initiatives are aimed at providing cost-effective solutions and extending market presence[1].

Financial Trajectory

Market Size and Growth

The global morphine sulfate market is projected to grow from USD 23.6 billion in 2023 to USD 49.1 billion by 2033, with a CAGR of 7.6%. This growth is driven by the increasing demand for pain management solutions and the expanding aging population[1].

Revenue Trends

The market is expected to continue its strong growth trajectory, with the morphine drugs market reaching $28.16 billion by 2028, growing at a CAGR of 6.6%[3].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the morphine sulfate market in 2020, causing a downfall in its growth trend. However, the market is expected to rise at a steady pace in the post-pandemic era due to an increased focus on healthcare and the rising use of morphine sulfate in treating chronic pain-related diseases[4].

Challenges and Restraints

Substance Abuse and Addiction Risks

Despite the growth potential, the morphine sulfate market faces significant challenges, including the risks of substance abuse and addiction. Morphine has a high dependence liability and addiction potential, which can hinder market growth in the long run[2][4].

Regulatory Considerations

Morphine is a highly regulated drug, classified as a Schedule II drug in the United States, Class A in the United Kingdom, and Schedule I in Canada. These regulatory constraints can affect market dynamics and the availability of the drug[2].

Key Takeaways

• The global morphine sulfate market is expected to grow significantly, driven by increasing demand for pain management and an aging population.
• The market is segmented by route of administration, application, and distribution channel, with parenteral administration and cancer treatment being key segments.
• North America dominates the market, but the Asia Pacific region is expected to see high growth.
• Key players are investing in research and development and strategic initiatives to expand their market presence.
• The market faces challenges such as substance abuse and regulatory constraints.

FAQs

What is the current market size of the global morphine sulfate market?

The global morphine sulfate market size is estimated to be worth USD 23.6 billion in 2023[1].

What is the projected growth rate of the morphine sulfate market?

The market is forecasted to grow at a CAGR of 7.6% from 2024 to 2033[1].

Which region dominates the morphine sulfate market?

North America dominates the market with a commanding 52.3% share[1].

What are the primary applications of morphine sulfate?

The primary applications include cancer, arthritis, myocardial infarction, kidney stones, and diarrhea, with cancer being the leading segment[1].

What are the major challenges facing the morphine sulfate market?

The major challenges include substance abuse and addiction risks, as well as regulatory constraints[2][4].

Sources

1. Market.us: Medical Morphine Market Size, Share | CAGR of 7.6% [https://market.us/report/medical-morphine-market/]
2. Wikipedia: Morphine [https://en.wikipedia.org/wiki/Morphine]
3. EIN Presswire: Morphine Drugs Market Size, Share, Revenue, Trends And Drivers For 2024-2033 [https://www.einpresswire.com/article/721483501/morphine-drugs-market-size-share-revenue-trends-and-drivers-for-2024-2033]
4. Facts and Factors: Morphine Sulfate Market Size, Share Global Analysis Report, 2022 [https://www.fnfresearch.com/morphine-sulfate-market]
5. TGA: AusPAR - Morphine sulfate pentahydrate [https://www.tga.gov.au/sites/default/files/auspar-morphine-sulfate-pentahydrate-190321.pdf]