Methylnaltrexone bromide - Generic Drug Details

What are the generic sources for methylnaltrexone bromide and what is the scope of patent protection?

Methylnaltrexone bromide is the generic ingredient in two branded drugs marketed by Actavis Llc, Salix Pharms, and Salix, and is included in three NDAs. There are fourteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylnaltrexone bromide has one hundred and thirty-seven patent family members in thirty-eight countries.

There are three drug master file entries for methylnaltrexone bromide. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for methylnaltrexone bromide

International Patents:	137
US Patents:	14
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	17
Patent Applications:	1,872
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for methylnaltrexone bromide
What excipients (inactive ingredients) are in methylnaltrexone bromide?	methylnaltrexone bromide excipients list
DailyMed Link:	methylnaltrexone bromide at DailyMed

Recent Clinical Trials for methylnaltrexone bromide

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

Sponsor	Phase
University of Alabama at Birmingham	N/A
Bausch Health Americas, Inc.	Phase 2/Phase 3
Karolinska University Hospital	Phase 4

See all methylnaltrexone bromide clinical trials

Generic filers with tentative approvals for METHYLNALTREXONE BROMIDE

Applicant	Application No.	Strength	Dosage Form
		12MG/0.6ML	SOLUTION;SUBCUTANEOUS
		12MG/0.6ML	INJECTABLE;SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for methylnaltrexone bromide

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for methylnaltrexone bromide

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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 METHYLNALTREXONE BROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RELISTOR	Tablets	methylnaltrexone bromide	150 mg	208271	1	2016-09-06
RELISTOR	Injection	methylnaltrexone bromide	8 mg/0.4 mL, Single Dose Prefilled Syringe	021964	1	2015-09-08
RELISTOR	Injection	methylnaltrexone bromide	12 mg/0.6 mL, Single Dose Vial	021964	1	2015-07-22

US Patents and Regulatory Information for methylnaltrexone bromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	AP	RX	Yes	Yes	9,669,096		Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	AP	RX	Yes	Yes	8,552,025		Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	AP	RX	Yes	Yes	9,180,125		Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008		RX	Yes	Yes	8,552,025		Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	AP	RX	Yes	Yes	8,822,490		Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	AP	RX	Yes	Yes	10,376,584		Y

Expired US Patents for methylnaltrexone bromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	10,376,584
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	6,559,158
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	8,552,025
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	10,376,584
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	9,669,096
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016	6,559,158

EU/EMA Drug Approvals for methylnaltrexone bromide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bausch Health Ireland Limited	Relistor	methylnaltrexone bromide	EMEA/H/C/000870 Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.	Authorised	no	no	no	2008-07-01

International Patents for methylnaltrexone bromide

Country	Patent Number	Title	Estimated Expiration
Mexico	2018015087	ANTAGONISTAS DE RECEPTORES DE OPIACEOS PERIFERICOS Y USOS DE LOS MISMOS. (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF.)
European Patent Office	1615646	FORMULATIONS PHARMACEUTIQUES CONTENANT DE LA METHYLNALTREXONE (PHARMACEUTICAL FORMULATIONS CONTAINING METHYLNALTREXONE)
Poland	3178472
Brazil	PI0919539	antagonistas de receptor de opioide periférico e empregos dos mesmos
Russian Federation	2013157119	АНТАГОНИСТЫ ПЕРИФЕРИЧЕСКИХ РЕЦЕПТОРОВ ОПИОИДОВ И ИХ ПРИМЕНЕНИЯ
Poland	3608322

Methylnaltrexone bromide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methylnaltrexone Bromide

Introduction to Methylnaltrexone Bromide

Methylnaltrexone bromide, marketed under the brand name Relistor, is a peripherally acting mu-opioid receptor antagonist (PAMORA) used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain and those with advanced illness[2].

Market Size and Growth

The opioid-induced constipation drugs market, which includes methylnaltrexone bromide, is experiencing significant growth. As of 2023, the global OIC drugs market was valued at USD 2.69 billion and is projected to reach USD 4.52 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period of 2024 to 2031[1].

Segmentation and Market Share

The OIC drugs market is segmented based on active ingredients, treatment types, modes of administration, end-users, and distribution channels. Methylnaltrexone bromide is one of the key active ingredients in this market, alongside naloxegol, lubiprostone, and docusate sodium.

• Active Ingredients: Methylnaltrexone bromide is part of the PAMORA class, which is gaining traction due to its efficacy in restoring normal bowel motility in constipated opioid-treated patients[2].
• Market Share: While lubiprostone currently holds the largest market share due to its benefits and advantages, methylnaltrexone bromide remains a significant player. However, naloxegol is expected to grow at the fastest CAGR during the forecast period, potentially impacting the market share of methylnaltrexone bromide[5].

Financial Trajectory

The financial performance of methylnaltrexone bromide is closely tied to the overall growth of the OIC drugs market.

• Revenue Growth: The increasing prevalence of chronic pain conditions and the expanding patient knowledge of OIC are key drivers of market growth. This trend is expected to continue, contributing to the financial success of methylnaltrexone bromide[3].
• Cost-Effectiveness: Studies have shown that treating OIC with methylnaltrexone bromide plus standard care is cost-effective, particularly in advanced-illness patients. This cost-effectiveness can offset the higher costs of the drug, making it a viable option for healthcare providers and patients[4].

Distribution and End-Users

Methylnaltrexone bromide is distributed through various channels and used by different end-users.

• Distribution Channels: The drug is available through hospital pharmacies, online pharmacies, and retail pharmacies. North America, with its robust market presence and significant healthcare expenditure, is a major distribution hub[1].
• End-Users: The primary end-users include hospitals, homecare settings, and specialty centers. The drug's use in these settings is driven by the need for effective OIC treatment in patients undergoing long-term opioid therapy[1].

Regulatory and Safety Considerations

The regulatory landscape for methylnaltrexone bromide is complex due to safety concerns associated with PAMORAs.

• FDA Approval: Methylnaltrexone bromide has received FDA approval for the treatment of OIC in adults with chronic non-cancer pain. However, the FDA has mandated post-marketing studies to investigate potential cardiovascular risks associated with PAMORAs[2].
• Safety Concerns: The FDA has identified cardiovascular events as a potential risk with PAMORAs, including methylnaltrexone bromide. Ongoing studies are aimed at assessing the major adverse cardiovascular event (MACE) risk associated with these drugs[2].

Competitive Landscape

The competitive landscape for methylnaltrexone bromide includes other PAMORAs and traditional OIC treatments.

• Competitors: Naloxegol (Movantik) and lubiprostone are significant competitors in the OIC market. Lubiprostone, in particular, is expected to overtake methylnaltrexone bromide’s market share due to its broader indications and patient population[5].
• Innovative Therapeutics: The development of innovative therapeutics with fewer side effects is an emerging opportunity in the OIC market. Strategic partnerships and research initiatives focusing on personalized medicine could further shape the competitive landscape[3].

Regional Market Dynamics

The regional dynamics play a crucial role in the market trajectory of methylnaltrexone bromide.

• North America: This region is expected to dominate the market due to the presence of major product manufacturers and significant healthcare expenditure. Research and development efforts in North America are driving the development of innovative OIC treatments[1].
• Asia-Pacific: This region is expected to witness significant growth due to advanced healthcare infrastructure and earlier drug approvals. The accelerated drug approval initiatives by regulatory bodies are likely to propel market growth in this region[1].

Challenges and Opportunities

Despite the growth potential, there are challenges and opportunities that impact the financial trajectory of methylnaltrexone bromide.

• Challenges: Regulatory hurdles, potential side effects, and high costs are significant challenges. Additionally, the social stigma associated with opioid use can negatively affect market growth[3].
• Opportunities: The development of innovative therapeutics with fewer side effects and strategic partnerships in research initiatives offer opportunities for growth. Capitalizing on these opportunities can help firms navigate the challenges and maintain market competitiveness[3].

Key Takeaways

• Market Growth: The OIC drugs market, including methylnaltrexone bromide, is projected to grow significantly, driven by increasing prevalence of chronic pain and advanced healthcare infrastructure.
• Cost-Effectiveness: Methylnaltrexone bromide is cost-effective, particularly in advanced-illness patients, despite higher initial costs.
• Regulatory Considerations: Ongoing studies are necessary to address cardiovascular safety concerns associated with PAMORAs.
• Competitive Landscape: The market is competitive, with other PAMORAs and traditional treatments vying for market share.
• Regional Dynamics: North America and Asia-Pacific are key regions driving market growth.

FAQs

Q1: What is methylnaltrexone bromide used for? Methylnaltrexone bromide is used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain and those with advanced illness.

Q2: What is the projected market size for the OIC drugs market by 2031? The global OIC drugs market is projected to reach USD 4.52 billion by 2031, with a CAGR of 6.7% during the forecast period of 2024 to 2031.

Q3: What are the main competitors of methylnaltrexone bromide in the OIC market? The main competitors include naloxegol (Movantik) and lubiprostone, with lubiprostone expected to overtake methylnaltrexone bromide’s market share.

Q4: What are the regulatory concerns associated with methylnaltrexone bromide? The FDA has identified potential cardiovascular risks associated with PAMORAs, including methylnaltrexone bromide, and has mandated post-marketing studies to investigate these risks.

Q5: Is methylnaltrexone bromide cost-effective? Yes, treating OIC with methylnaltrexone bromide plus standard care is cost-effective, particularly in advanced-illness patients, as it reduces other constipation-related costs.

Sources

1. Data Bridge Market Research: Global Opioid Induced Constipation Drugs Market Size & Statistics By 2031.
2. FDA: Methylnaltrexone bromide oral tablet, Relistor® NDA 208271.
3. GlobeNewswire: Opioid-Induced Constipation (OIC) Therapeutics Market Forecast 2025-2030.
4. PubMed: Methylnaltrexone bromide for the treatment of opioid-induced constipation.
5. Verified Market Research: Opioid Induced Constipation Market Size, Share, Opportunities.