Morphine sulfate; naltrexone hydrochloride - Generic Drug Details

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

Morphine sulfate; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate; naltrexone hydrochloride has seventy-four patent family members in twenty-three countries.

Summary for morphine sulfate; naltrexone hydrochloride

International Patents:	74
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	6
DailyMed Link:	morphine sulfate; naltrexone hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for morphine sulfate; naltrexone hydrochloride

Constraining patent/regulatory exclusivity:

8,846,104

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for morphine sulfate; naltrexone hydrochloride

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

Sponsor	Phase
Pfizer	Phase 4
Pfizer	Phase 3
Ranbaxy Inc.	Phase 1

See all morphine sulfate; naltrexone hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for morphine sulfate; naltrexone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	20 mg/0.8 mg	022321	1	2018-08-16
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	30 mg/1.2 mg 50 mg/2 mg 80 mg/3.2 mg	022321	1	2010-05-28
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	60 mg/2.4 mg	022321	1	2010-05-25
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	100 mg/4 mg	022321	1	2010-05-03

US Patents and Regulatory Information for morphine sulfate; naltrexone hydrochloride

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	022321-002	Aug 13, 2009		DISCN	Yes	No	7,682,634		Y
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009		DISCN	Yes	No	8,846,104		Y
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009		DISCN	Yes	No	7,682,633
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No	8,623,418
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009		DISCN	Yes	No	8,158,156

Expired US Patents for morphine sulfate; naltrexone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009	5,202,128
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009	5,202,128
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009	5,378,474
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009	5,202,128
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009	5,202,128

International Patents for morphine sulfate; naltrexone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Cyprus	1119334
Cyprus	1118982
Australia	2016238844	PHARMACEUTICAL COMPOSITIONS
Hungary	E038446
Canada	2709903	COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)

Morphine sulfate; naltrexone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Morphine Sulfate and Naltrexone Hydrochloride

Introduction

Morphine sulfate and naltrexone hydrochloride are crucial components in the management of chronic pain, particularly in formulations designed to mitigate opioid abuse. This article delves into the market dynamics and financial trajectory of these drugs, highlighting their current status, future projections, and the factors influencing their market.

Market Size and Growth

The global morphine sulfate market is experiencing significant growth. Projected to expand from USD 23.6 billion in 2023 to USD 49.1 billion by 2033, this market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.6%[2].

Key Drivers of Growth

Several factors are driving this growth:

Increasing Prevalence of Chronic Pain

The rising incidence of chronic pain, particularly in non-cancer patients, is a major driver. This has led to an increased demand for effective and safe pain management solutions[3].

Regulatory Support

Regulatory bodies, such as the FDA, have been supportive of opioid formulations with abuse-deterrent properties. Approvals for products like MorphaBond and Embeda, which contain morphine sulfate and naltrexone hydrochloride, have bolstered the market[3].

Technological Advancements

Advancements in drug formulation technology, such as extended-release and abuse-deterrent formulations, have improved the therapeutic integrity and safety of these drugs. For instance, Embeda (morphine sulfate and naltrexone hydrochloride) is designed to release naltrexone when tampered with, mitigating the euphoric effects of morphine[4].

Market Segmentation

The market for morphine sulfate and naltrexone hydrochloride can be segmented based on several factors:

Dosage Forms

Extended-release tablets and capsules, such as MorphaBond and Embeda, are gaining traction due to their abuse-deterrent properties. Other forms include injectable solutions and liposomal formulations like DepoDur[2][3].

Therapeutic Applications

These drugs are primarily used for managing chronic, moderate-to-severe pain. They are also used in specific cases such as opioid-tolerant pediatric patients and for post-surgical pain management[3].

Geographic Regions

The market is global, with significant demand in regions with high prevalence of chronic pain and opioid use. North America and Europe are key markets, but there is growing demand in Asia-Pacific as well[2].

Financial Trajectory

The financial trajectory of morphine sulfate and naltrexone hydrochloride is influenced by several factors:

Patent Landscape

The patent landscape is complex, with numerous patents and patent applications related to these drugs. For example, there are 59 international patents and 16 US patents related to morphine sulfate. The expiration of these patents can lead to the entry of generic versions, affecting market dynamics[2].

Generic Competition

The approval of generic abuse-deterrent formulations is expected to increase competition and reduce costs. The FDA's draft guidance on generic abuse-deterrent formulations aims to spur innovation and make these products more accessible[5].

Pricing Trends

Drug prices for morphine sulfate formulations vary widely depending on the dosage form and brand. For instance, extended-release tablets like MorphaBond and Arymo ER have different pricing structures compared to injectable solutions[2].

Regulatory Environment

The regulatory environment plays a critical role in shaping the market:

FDA Approvals and Guidelines

The FDA has approved several morphine sulfate and naltrexone hydrochloride formulations with abuse-deterrent properties. The agency's guidelines for industry, such as the 2015 guidance on abuse-deterrent opioids, have set standards for these products[3].

Public Health Initiatives

Initiatives to combat opioid abuse, such as making naloxone more widely available, also impact the market. These efforts aim to balance pain management with opioid safety[3].

Pharmacodynamic Effects and Abuse Deterrence

Studies have shown that formulations like MSN (morphine sulfate and naltrexone hydrochloride) significantly reduce the positive subjective ratings associated with morphine when tampered with. This is due to the release of naltrexone, which mitigates the euphoric effects of morphine[1][4].

Industry Expert Insights

Industry experts emphasize the importance of balancing pain management with safety. For example, Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research, has highlighted the need for innovative solutions that reduce the risk of opioid abuse while providing effective pain relief[3].

Statistics and Data

• The global morphine sulfate market is projected to grow at a CAGR of 7.6% from 2023 to 2033[2].
• Over 199 clinical trials are ongoing or have been completed for morphine sulfate formulations[2].
• The FDA has approved several abuse-deterrent opioid formulations, including MorphaBond and Embeda[3].

Key Takeaways

• The morphine sulfate market is growing significantly due to increasing demand for chronic pain management and regulatory support.
• Abuse-deterrent formulations are a key focus, with technologies like extended-release and naltrexone-sequestered formulations gaining traction.
• The regulatory environment, including FDA approvals and guidelines, is crucial in shaping the market.
• Generic competition is expected to increase, driven by FDA guidance on generic abuse-deterrent formulations.
• Public health initiatives to combat opioid abuse also influence market dynamics.

FAQs

Q: What is the projected growth rate of the global morphine sulfate market?

A: The global morphine sulfate market is projected to grow at a CAGR of 7.6% from 2023 to 2033[2].

Q: How do abuse-deterrent formulations like MSN work?

A: Formulations like MSN release naltrexone when tampered with, which mitigates the euphoric effects of morphine, reducing the potential for abuse[1][4].

Q: What role does the FDA play in the market for morphine sulfate and naltrexone hydrochloride?

A: The FDA plays a crucial role through approvals, guidelines, and initiatives aimed at balancing pain management with opioid safety[3].

Q: What are the primary dosage forms of morphine sulfate and naltrexone hydrochloride?

A: The primary dosage forms include extended-release tablets, capsules, injectable solutions, and liposomal formulations[2][3].

Q: How does the patent landscape affect the market for these drugs?

A: The patent landscape influences the entry of generic versions, which can increase competition and reduce costs once key patents expire[2].

Sources

1. Assessment of Pharmacodynamic Effects Following Oral Administration of Crushed Morphine Sulfate and Naltrexone Hydrochloride Extended-Release Capsules. Academic.oup.com.
2. Generic MORPHINE SULFATE INN equivalents, drug patent and market information. Drugpatentwatch.com.
3. Timeline of Selected FDA Activities and Significant Events. FDA.gov.
4. Morphine sulfate and naltrexone hydrochloride extended-release capsules: naltrexone release, pharmacodynamics, and tolerability. PubMed.ncbi.nlm.nih.gov.
5. FDA Briefing Document. FDA.gov.