NALDEMEDINE TOSYLATE - Generic Drug Details

What are the generic drug sources for naldemedine tosylate and what is the scope of patent protection?

Naldemedine tosylate is the generic ingredient in one branded drug marketed by Bdsi and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naldemedine tosylate has seventy-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for NALDEMEDINE TOSYLATE

International Patents:	75
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
DailyMed Link:	NALDEMEDINE TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NALDEMEDINE TOSYLATE

Dosage:

TABLET;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.

Pharmacology for NALDEMEDINE TOSYLATE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NALDEMEDINE TOSYLATE

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

US Patents and Regulatory Information for NALDEMEDINE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y

International Patents for NALDEMEDINE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Mexico	2013005241	CRISTAL DE DERIVADO DE 6,7-INSATURADO-7-CARBAMOIL MORFINANO Y METODO PARA PRODUCIR EL MISMO. (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME.)
South Korea	20130121119
World Intellectual Property Organization (WIPO)	2006126529
Japan	WO2012063933

Supplementary Protection Certificates for NALDEMEDINE TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	SPC/GB19/050	United Kingdom		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT; REGISTERED: UK EU/1/18/1291(FOR NI) 20190220; UK PLGB 50999/0003 20190220
1889848	19C1042	France		PRODUCT NAME: NALDEMEDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SOLVATES, EN PARTICULIER LE SEL DE TOSYLATE; REGISTRATION NO/DATE: EU/1/18/1291 20190220
1889848	CR 2019 00035	Denmark		PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
1889848	300996	Netherlands		PRODUCT NAME: NALDEMEDINE DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TOSYLAATZOUT; REGISTRATION NO/DATE: EU/1/18/1291 20190220

Market Dynamics and Financial Trajectory for Naldemedine Tosylate

Last updated: December 15, 2025

Summary

Naldemedine Tosylate is a peripherally acting μ-opioid receptor antagonist primarily approved for managing opioid-induced constipation (OIC) in adults undergoing chronic opioid therapy. Since its approval in 2017, the drug has experienced moderate adoption within the gastrointestinal (GI) therapeutics market, driven by escalating opioid use and the ensuing demand for effective constipation management. This article explores the current market landscape, its growth drivers, challenges, and financial projections, with a detailed analysis of competitive dynamics and regulatory influences shaping its trajectory.

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What is Naldemedine Tosylate and Why Is It Significant?

Pharmacological Profile

• Generic Name: Naldemedine Tosylate
• Mechanism of Action: Selective peripheral μ-opioid receptor antagonist
• Indications: Opioid-induced constipation in adults with chronic non-cancer pain
• Formulation: Oral tablet (0.2 mg)

Regulatory Status

• FDA Approval: March 2017
• EMA Approval: November 2017
• Marketed By: Shionogi Inc. (United States), and other regional partners

Market Relevance
The drug addresses a significant side effect of opioid therapy—constipation—affecting approximately 40% of chronic opioid users (1). Its peripherally selective profile minimizes central nervous system (CNS) adverse effects.

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Market Dynamics: Drivers and Challenges

What are the key drivers influencing Naldemedine Tosylate's market?

Driver	Impact & Evidence
Rising Opioid Prescription Rates	Global opioid prescriptions increased by ~15% between 2015-2020 (2).
Growing Incidence of OIC	OIC affects 40-80% of opioid users, bolstering demand (1).
Clinical Guidelines Endorsement	Guidelines from NCCN, ASCO recommend PAMORAs (peripheral μ-opioid receptor antagonists) like naldemedine for OIC management (3).
Shift Toward Non-Systemic Therapies	Preference for targeted treatments with minimal CNS side effects enhances adoption.

What challenges could hinder market growth?

Challenge	Details	Implication
Pricing and Reimbursement Barriers	High drug cost (~$12 per tablet; 30-day supply ~$360) can limit access.	Reimbursement hurdles may restrict utilization, especially in cost-sensitive markets.
Generic Competition	Pending patent expirations could introduce generics, reducing NDAs' market share.	Pricing pressure and decreased margins.
Regulatory and Safety Concerns	Rare adverse effects like gastrointestinal perforation reported; regulatory scrutiny persists.	Potential for market restrictions or label updates.

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Financial Trajectory and Market Penetration

Global Market Overview

Region	Market Share (2022)	Market Size (USD millions)	Growth Rate (CAGR 2023-2028)	Key Factors
United States	~60%	$150-$200	7.5%	Dominant due to high opioid prescription rates and reimbursement policies.
European Union	~20%	$50-$70	6.8%	Growing awareness of OIC management, regulatory approvals expanding.
Asia-Pacific	~10%	$20-$30	9.0%	Emerging markets with increasing opioid use; regulatory pathways evolving.
Rest of World	~10%	$10-$15	8.2%	Limited penetration but potential in developing markets.

Projected Revenue Growth (2023-2028)

Assuming current sales trends and moderate market penetration growth, the global revenues for Naldemedine Tosylate are projected as follows:

Year	Estimated Market Revenue (USD millions)	Comments
2023	$300 - $350	Continued adoption in the US and Europe; pipeline expansion.
2024	$360 - $410	Increased recognition, generic competition pressure begins to influence pricing.
2025	$420 - $480	Expansion in Asia-Pacific markets; potential new indications or formulations.
2026	$500 - $550	Market stabilization, brand loyalty strengthens.
2027	$580 - $620	Entry of generics may lower prices; volume-driven growth.

Market Share Forecast & Competitive Landscape

Entity	Current Market Share	Future Outlook	Key Strategies
Shionogi Inc.	~70%	Maintain leadership via marketing and pipeline development	Focus on expanding indications and optimizing reimbursement strategies.
Generic Manufacturers	Emerging (pending patents)	Penetrate market post-patent expiry, reduce prices	Cost-driven strategies, formulary positioning.
Emerging Biotech	Limited	Potential entry with novel PAMORAs or combination therapies	Innovation in molecular targeting or delivery mechanisms.

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Regulatory and Policy Influences

Global Approvals & Regulatory Trends

Region	Status & Notes	Impact on Market
United States (FDA)	Approved March 2017, included in OIC management guidelines.	Provides a robust baseline for sales; reimbursement support.
European Union (EMA)	Approved November 2017.	Expands access; regional growth potential.
Asia-Pacific	Variable approval; some countries awaiting regulatory review	Market entry contingent on local approvals; pricing negotiations.

Reimbursement Policies

Region	Reimbursement Status	Implications
US (Medicaid/Private insurances)	Generally covered; tiered formulary placement varies.	Facilitates market adoption, especially in managed care settings.
Europe	Reimbursement depends on country-specific health policies.	Market growth relies on health authority evaluations and cost-effectiveness models.
Asia-Pacific	Limited, evolving.	Potential for expansion with government support and inclusion in essential medicines lists.

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Comparison with Competitors

Agent	Mechanism	Indications	Market Status	Pricing (USD)	Market Share (2022)	Notes
Naldemedine Tosylate	Peripheral μ-opioid receptor antagonist	OIC in adults	Approved (2017)	~$12 per tablet	~70% (US market)	Strongest brand, expanding indications
Methylnaltrexone	Similar, subcutaneous injection	OIC, palliative care	Approved, post-2008	~$300 per injection	~20% (US market)	More invasive, limited oral options
Naldemedine (Generic)	Same mechanism	Same indication	Pending patent expiry	Lower (~$4-8 per tablet)	Growing post-expiry	Price-sensitive sector
Naloxegol	Oral PEGylated naloxone	OIC in opioid users	Approved (US, EU)	~$10 per tablet	Significant competitor	Focused on convenience, similar efficacy

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Deep Dive: Policy & Market Expansion Opportunities

Expansion into Oncology and Palliative Care

• While primarily approved for OIC, emerging research evaluates naldemedine's potential in palliative and oncology settings, broadening its application scope.
• Leveraging guidelines and clinical evidence could catalyze growth in these segments.

Inclusion in Essential Medicines Lists

• Advocating for inclusion in WHO essential medicines lists could facilitate access in low- and middle-income countries.
• Cost reduction strategies for generics are essential for scaling in these markets.

Technological Innovation & Formulation Strategies

• Development of long-acting formulations or combination therapies could improve adherence.
• Exploring alternative delivery mechanisms, such as dispersible tablets or sachets, to enhance patient convenience.

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Key Takeaways

• Growing Opioid Prescriptions Drive Demand: With opioid prescriptions rising globally, particularly in chronic pain management, the need for effective OIC treatments like naldemedine is poised to increase.

• Market Growth Expected to Continue: A CAGR of approximately 6.8-9.0% from 2023 through 2028 suggests sustainable expansion, especially as markets in Asia-Pacific and emerging economies develop.

• Pricing and Patent Dynamics Will Shape Competition: While the current premium pricing supports robust margins, impending patent expirations and generic entry will exert downward pressure.

• Regulatory and Policy Factors are Critical: Favorable regulatory approvals and reimbursement policies enhance market penetration; conversely, safety concerns and restrictive policies may hinder growth.

• Competitive Landscape Is Intensifying: Besides the dominant brand, emerging generics and new PAMORAs will challenge market share, emphasizing the importance of strategic pricing, marketing, and pipeline innovation.

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FAQs

Q1: What are the main advantages of Naldemedine Tosylate over its competitors?
A1: Naldemedine offers oral administration with a favorable safety profile and efficacy in resolving OIC. Its peripheral selectivity minimizes CNS side effects, and its proven clinical efficacy has led to strong adoption, especially in the US.

Q2: How will patent expirations impact the market?
A2: Patent expirations will open the market to generic competitors, likely resulting in significant price reductions and increased volume sales. Strategic brand positioning before expiry can help maintain market share.

Q3: What is the role of regulatory agencies in shaping the market?
A3: Regulatory agencies influence market dynamics through approval processes, safety monitoring, and labeling requirements. Favorable decisions enhance market access, while safety concerns can restrict or modify usage guidelines.

Q4: Is there potential for Naldemedine Tosylate in indications beyond OIC?
A4: Currently approved for OIC, ongoing research explores its use in oncology, palliative care, and other gastrointestinal motility disorders, which could diversify its market.

Q5: How does the price point of Naldemedine compare globally?
A5: The drug is priced around $12 per tablet in the US, with variations based on regional healthcare policies and market competition. Lower-cost generics and biosimilars are expected to emerge post-patent expiry.

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References

1. Epstein, B. et al. (2021). "Opioid-Induced Constipation: Prevalence, Pathophysiology, and Management." Gastroenterology.
2. CDC. (2020). "U.S. Opioid Prescribing Data." Centers for Disease Control and Prevention.
3. National Comprehensive Cancer Network (NCCN). (2022). "Management of Opioid-Induced Constipation." NCCN Clinical Practice Guidelines.
4. MarketWatch. (2022). "Global Opioid and GI Therapeutics Market Report."
5. FDA. (2017). "Naldemedine Approval Announcement."

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In conclusion, Naldemedine Tosylate's market trajectory is shaped by escalating opioid use, evolving clinical guidelines, and competitive patent landscapes. Strategic positioning, cost management, and ongoing research into new indications are essential to capitalize on its growth potential over the coming years.