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

Constraining patent/regulatory exclusivity:

10,952,968

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	9,108,975		Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	10,952,968		Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	12,350,377		Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	RE46365		Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	RE46375		Y	Y

International Patents for naldemedine tosylate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013172297
Canada	2609733	DERIVE DE MORPHINANE SUBSTITUE PAR UN CARBAMOYLE EN POSITION7 ET AYANT UNE INSAURATION EN POSITION 6,7 (6,7-UNSATURATED-7-CARBAMOYL SUBSTITUTED MORPHINAN DERIVATIVE)
Slovenia	2639234
Israel	243188
Canada	2814195
Poland	2639234

Supplementary Protection Certificates for naldemedine tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	C 2019 033	Romania		PRODUCT NAME: NALDEMEDINA SAU O SARE SAU SOLVAT ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF NATIONAL AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218
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	122019000063	Germany		PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	CA 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	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	1990036-4	Sweden		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220

Market Dynamics and Financial Trajectory for Naldemedine Tosylate

Last updated: July 29, 2025

Introduction

Naldemedine tosylate, marketed under the brand name Symproic among others, is a peripherally acting mu-opioid receptor antagonist (PAMORA). Approved by the U.S. Food and Drug Administration (FDA) in 2017, it addresses opioid-induced constipation (OIC), a common and debilitating side effect among patients receiving long-term opioid therapy for chronic pain. Its unique mechanism of action and targeted therapeutic profile position naldemedine as a significant asset within the pharmaceutical sector, influencing both market dynamics and its financial trajectory.

This comprehensive analysis explores market drivers, competitive landscape, regulatory influences, pricing strategies, and prospective growth, providing a strategic outlook for stakeholders considering investments or market positioning related to naldemedine tosylate.

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Market Demand and Clinical Context

The rise in opioid prescriptions globally has escalated the incidence of OIC, which affects approximately 40-80% of patients on chronic opioid therapy [1]. The unmet need for effective, targeted treatments ensures sustained demand for drugs like naldemedine. The expanding opioid user base, especially within developed markets such as North America and Europe, directly correlates with an increasing market for OIC therapies.

Furthermore, the aging global population amplifies the prevalence of chronic pain conditions, augmenting opioid utilization and subsequent OIC cases. According to the CDC, opioids are prescribed at approximately 51.4 prescriptions per 100 persons annually in the U.S., underscoring the sizable market for antipripotic agents [2].

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Market Dynamics

1. Competitive Landscape

Naldemedine's primary competitors include other PAMORAs—methylnaltrexone (Relistor/Relival), naloxegol (Movantik), and similar agents. While all target OIC, variations in efficacy, safety, ease of administration, and pricing influence market share distribution.

• Methylnaltrexone holds an earlier market entry and has broader indications, including opioid-induced bowel dysfunction (OIBD).
• Naloxegol benefits from oral administration and a favorable safety profile, competing directly with naldemedine.

2. Regulatory Milestones and Approvals

Naldemedine's approval reflects positive clinical trial outcomes demonstrating efficacy in increasing spontaneous bowel movements with minimal central nervous system penetration, thus reducing CNS-related side effects such as opioid withdrawal or dependency concerns. Besides the FDA, regulatory agencies in Europe, Japan, and other territories have granted approvals, although the timeline varies, influencing international market expansion.

3. Pricing and Reimbursement Policies

Pricing strategies are critical. Naldemedine's pricing is aligned with premium medications in the OIC space. Payers require demonstration of cost-effectiveness, which hinges on clinical benefits and impact on patient quality of life. In the U.S., reimbursement approvals have facilitated access, though formulary placements remain competitive.

4. Prescriber Acceptance and Market Penetration

Physician awareness and comfort influence uptake. Educational initiatives and clinical guideline endorsements (e.g., American Pain Society) bolster prescriptive rates. Despite its advantages, naldemedine's market penetration is influenced by clinician familiarity with oral PAMORAs and perceived comparative efficacy.

5. Patent Life and Generic Competition

Currently, naldemedine enjoys market exclusivity until approximately 2032, providing a window for revenue growth. The advent of generics or biosimilars could erode patent-protected revenue streams, emphasizing the need for strategic lifecycle management.

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Financial Trajectory Analysis

1. Revenue Growth Potential

The global OIC therapeutics market was valued at USD 1.4 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of approximately 5-7% through 2028 [3]. Naldemedine’s contribution, presently considered niche, is expected to strengthen as awareness and prescriber confidence increase.

In particular, the North American market dominates demand, driven by high opioid prescription rates. Market analysts forecast the naldemedine segment could attain USD 150-200 million annually within the next five years, contingent upon market expansion and competitive dynamics.

2. R&D and Commercial Investment

The pathway to market comprises substantial R&D expenditure, clinical trials, and post-marketing surveillance costs. Ongoing efforts aim to expand indications, possibly including OIC in other populations or adjunctive therapies, which could diversify revenue streams.

3. Strategic Alliances and Licensing

Partnerships with regional pharmaceutical firms could accelerate market access and penetration, particularly in emerging markets where patent protections are often weaker or forthcoming.

4. Sales and Marketing Trends

Marketing investments focus on neurologists, pain specialists, and oncology teams. Digital health platforms and real-world evidence are increasingly employed to demonstrate efficacy and safety, fostering adherence and expanding prescribing habits.

5. Impact of Regulatory and Patent Landscapes

Potential patent expirations around 2032 underscore the necessity for pipeline development, for example, formulations with extended-release profiles or combination therapies, to sustain revenue flow.

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Future Outlook and Growth Catalysts

• Expansion into New Indications: Trials assessing naldemedine in bowel management for conditions such as neurogenic bowel disorders may open additional markets.
• Global Market Penetration: While North America dominates, emerging markets in Asia-Pacific and Latin America, driven by rising opioid use, present significant growth opportunities.
• Innovations in Delivery: Development of generic versions post-patent expiry, alongside formulation improvements, could offer cost advantages and stimulate adoption.
• Patient-Centric Approaches: Integration with digital health solutions to monitor compliance and outcomes will strengthen patient engagement, potentially translating to increased market share.

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Key Regulatory and Ethical Considerations

• Safety Profile: The central concern remains minimal CNS penetration to avoid opioid antagonism in the brain. Ongoing pharmacovigilance is vital.
• Pricing Strategies: Balancing affordability with profitability, while maintaining access, remains challenging amid healthcare reforms aiming at cost containment.
• Market Access Policies: Differing international regulatory standards and reimbursement schemes could impact global revenue streams.

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Conclusion

Naldemedine tosylate operates within a niche but expanding segment, primarily driven by the global opioid epidemic's consequences. Its ongoing clinical validation, regulatory approval in key markets, and strategic positioning will determine its financial trajectory. Given patent protections and growing demand, the drug’s revenue prospects remain optimistic, albeit susceptible to competitive and regulatory shifts. Stakeholders should focus on lifecycle management, geographic expansion, and innovation to sustain growth.

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Key Takeaways

• The rising prevalence of opioid-induced constipation guarantees sustained market demand for naldemedine.
• Competitive landscape includes established PAMORAs, necessitating differentiation via efficacy, safety, and value-added services.
• Regulatory approvals in major markets and positive safety profiles underpin favorable market entry prospects.
• Pricing strategies and reimbursement policies critically influence market penetration and revenue generation.
• Patent life until 2032 offers a window for expansion, but proactive pipeline development remains essential for long-term growth.

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FAQs

1. What distinguishes naldemedine from its competitors?
   Naldemedine's proprietary molecular structure enables targeted peripheral action with minimal CNS penetration, reducing central side effects and improving tolerability compared to some competitors.

2. Are there any significant safety concerns associated with naldemedine?
   Clinical trials indicate a favorable safety profile; however, ongoing pharmacovigilance is necessary to monitor rare adverse events, such as gastrointestinal perforation, particularly in vulnerable populations.

3. What are the prospects for naldemedine in emerging markets?
   Expanding awareness, regulatory approvals, and pricing negotiations will be critical. Collaborations with local firms can accelerate market entry and adoption.

4. How might patent expiry impact naldemedine's marketability?
   Patent expiry around 2032 could lead to generic competition, necessitating lifecycle strategies like new formulations, expanded indications, or combination therapies.

5. What is the potential for future indications beyond opioid-induced constipation?
   Research into naldemedine's efficacy for other gastrointestinal and neurogenic bowel conditions is ongoing, potentially broadening its therapeutic scope and financial appeal.

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References

[1] Copley JB, et al. "Opioid-induced constipation: a review of epidemiology and pathophysiology." Pain Medicine, 2016.
[2] CDC. "Opioid Prescriptions in the United States." Centers for Disease Control and Prevention, 2021.
[3] Market Research Future. "Global Opioid-Induced Constipation Therapeutics Market Analysis and Forecast." 2022.