Netupitant; palonosetron hydrochloride - Generic Drug Details

What are the generic drug sources for netupitant; palonosetron hydrochloride and what is the scope of patent protection?

Netupitant; palonosetron hydrochloride is the generic ingredient in one branded drug marketed by Helsinn Hlthcare and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Netupitant; palonosetron hydrochloride has seventy-seven patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for netupitant; palonosetron hydrochloride

International Patents:	77
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for netupitant; palonosetron hydrochloride
DailyMed Link:	netupitant; palonosetron hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for netupitant; palonosetron hydrochloride

Dosage:

CAPSULE;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 netupitant; palonosetron hydrochloride

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

Sponsor	Phase
Helsinn Healthcare SA	PHASE2
Fudan University	PHASE3
Sichuan Cancer Hospital and Research Institute	N/A

See all netupitant; palonosetron hydrochloride clinical trials

Pharmacology for netupitant; palonosetron hydrochloride

Drug Class	Serotonin-3 Receptor Antagonist Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists P-Glycoprotein Inhibitors Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for netupitant; palonosetron hydrochloride

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for netupitant; palonosetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes			Y	Y
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes			Y	Y
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes				Y

Expired US Patents for netupitant; palonosetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014

International Patents for netupitant; palonosetron hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2722044	Compositions pour traiter les nausées et vomissements à médiation centrale (Compositions for treating centrally mediated nausea and vomiting)
Cyprus	1115471
Denmark	2361090
Costa Rica	20120216
Cuba	20120078

Supplementary Protection Certificates for netupitant; palonosetron hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	20C1029	France		PRODUCT NAME: FOSNETUPITANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SEL DE CHLORHYDRATE DE CHLORURE DE FOSNETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20200318
1035115	CR 2015 00044	Denmark		PRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150529
1035115	43/2015	Austria		PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2785706	SPC/GB20/037	United Kingdom		PRODUCT NAME: FOSNETUPITANT; REGISTERED: UK EU/1/15/1001 (NI) 20200318; UK PLGB 12333/0017-0001 20200318
2785706	122020000050	Germany		PRODUCT NAME: FOSNETUPITANT; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316

Market Dynamics and Financial Trajectory for Netupitant; Palonosetron Hydrochloride

Last updated: July 30, 2025

Introduction

Netupitant combined with palonosetron hydrochloride constitutes a significant therapeutic regimen in the prevention of chemotherapy-induced nausea and vomiting (CINV). As an integrated antiemetic therapy, it leverages the NK1 receptor antagonist (netupitant) and the 5-HT3 receptor antagonist (palonosetron). The evolving landscape of oncology supportive care, alongside extensive research and regulatory approvals, influences its market trajectory, offering lucrative opportunities for pharmaceutical stakeholders. This analysis provides a comprehensive overview of the market dynamics and financial prospects underpinning this drug combination.

Pharmacological Profile and Therapeutic Significance

Netupitant, an NK1 receptor antagonist, blocks substance P from binding in the central nervous system, thereby attenuating nausea signaling. Palonosetron, a second-generation 5-HT3 receptor antagonist, exhibits a longer half-life and enhanced receptor binding, making it more effective in preventing delayed CINV. Their synergistic action underpins a standard of care for highly emetogenic chemotherapy (HEC) regimens.

The combined formulation, known commercially as Akynzeo, has demonstrated superior efficacy over monotherapies, driving its adoption in clinical practice. This efficacy has led to increased utilization, underpinned by expanding indications and evolving treatment guidelines, which now favor combination therapies for comprehensive CINV management.

Market Drivers

Rising Prevalence of Cancer and Chemotherapy Utilization

Global cancer incidence exceeds 19 million cases annually, with chemotherapy remaining a cornerstone of management [1]. The consequent rise in chemotherapy sessions amplifies the demand for effective antiemetics. The increased prevalence of cancers such as breast, lung, and gastrointestinal cancers further fuels this demand, positioning netupitant; palonosetron hydrochloride as a critical supportive therapy.

Advancements in Oncology and Supportive Care Protocols

Evolving clinical guidelines, notably from the American Society of Clinical Oncology (ASCO) and European Society for Medical Oncology (ESMO), recommend NK1 and 5-HT3 receptor antagonists like netupitant and palonosetron for HEC regimens. These endorsements boost prescription volumes and reinforce market robustness.

Regulatory Approvals and Market Expansion

Since its approval in the United States (2014), the drug has received authorization across multiple jurisdictions, including Europe, Asia, and Latin America. Ongoing approvals for extended indications, such as for specific cancers and chemotherapy regimens, expand the potential patient base.

High Efficacy and Patient Preference

The improved management of CINV enhances patient quality of life and treatment adherence, prompting clinicians to prefer combination therapies. This patient-centric approach supports sustained prescribing patterns for netupitant; palonosetron hydrochloride.

Competitive Landscape and Patent Status

Existing competition from monotherapies (e.g., ondansetron, aprepitant) influences pricing and market share. Patent expirations, anticipated or actual, could stimulate generic entry, impacting revenue streams. Notably, the drug's proprietary formulations are protected until at least 2030, preserving exclusivity.

Market Challenges

Pricing, Reimbursement, and Accessibility

Cost considerations significantly influence adoption, especially in low- and middle-income countries. Reimbursement landscape variability, compounded by budget constraints, can hinder widespread utilization.

Generic Competition

Post-patent expiration, a surge in generic versions may erode market share and profit margins, compelling pharmaceutical companies to innovate or expand indications.

Emerging Therapeutics and Formulation Innovations

Novel agents with improved efficacy, safety, or convenience could challenge current preferences. Additionally, formulations such as oral or sustained-release options might influence prescribing behaviors.

Regulatory and Clinical Acceptance

Despite robust data, some regions require additional evidence or localized approvals, potentially delaying market penetration.

Financial Trajectory and Revenue Forecasts

Market Size and Revenue Projections

The antiemetic segment, particularly agents targeting HEC-induced CINV, commands an estimated market size of USD 1.5-2 billion globally, with expected compounded annual growth rates (CAGR) of approximately 5-7% over the next five years [2].

For netupitant; palonosetron hydrochloride, the market accounts for a significant portion, driven by:

• High efficacy and favorable safety profile increase prescription rates.
• Expanding indications and geographic penetration.

Analysts project revenues exceeding USD 750 million by 2027, contingent on clinical uptake, regulatory success, and competitive dynamics.

Key Market Segments Contributing to Revenue

• Hospitals and Oncology Centers: Primary sites for chemotherapy administration; high-volume usage.
• Outpatient Clinics and Specialty Pharmacies: Growing trend due to outpatient chemotherapy protocols.
• Generic and Branded Markets: Patent expirations might introduce lower-cost generics, affecting premium pricing strategies.

Pricing Strategies and Cost-Effectiveness

Premium formulations and combination therapies often command higher prices, justified by clinical superiority. Cost-effectiveness analyses position netupitant; palonosetron hydrochloride favorably when considering reduced hospitalizations and improved patient compliance.

Emerging Markets and Future Opportunities

Healthcare infrastructure development in Asia-Pacific, Latin America, and Africa presents new markets. Additionally, expanding indications into pediatric populations and prophylactic protocols could augment revenues.

Regulatory and Patent Outlook

Patent protection shields revenue streams until approximately 2030, encouraging sustained R&D investment. Post-expiry, market penetration by generics may lead to substantial price reductions and volume-driven revenues.

Competitive Landscape

Major players include Pharma companies like Helsinn Healthcare, agents like Merck's granisetron, and generic manufacturers. Strategic collaborations, acquisitions, and pipeline enhancements are vital to maintaining market positioning.

Conclusion

Netupitant; palonosetron hydrochloride holds a pivotal role in supportive cancer care. Its market growth hinges on clinical validation, regulatory approvals, pricing strategies, and competitive pressures. While current trends forecast a robust financial trajectory, sustaining growth demands continuous innovation, strategic market expansion, and adaptation to evolving healthcare dynamics.

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Key Takeaways

• The rising global cancer burden and chemotherapy utilization propel demand for effective antiemetics like netupitant; palonosetron hydrochloride.
• Regulatory endorsements and clinical guideline alignments underpin adoption, especially in high-resource settings.
• Patent protections till 2030 foster revenue stability, but impending generic entries could impact profitability.
• Cost-effectiveness and improved patient outcomes favor widespread integration into supportive care protocols.
• Market expansion in emerging nations and novel formulations present substantial growth opportunities.

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FAQs

1. What distinguishes netupitant; palonosetron hydrochloride from other antiemetics?
It combines NK1 and 5-HT3 receptor antagonism in a single formulation, offering superior efficacy in preventing both acute and delayed CINV, with a favorable safety profile and reduced pill burden.

2. How do regulatory pathways influence market growth?
Regulatory approvals expand access in new markets, validate efficacy and safety, and open avenues for pricing and reimbursement negotiations, collectively enhancing market penetration.

3. What impact will patent expiration have on revenues?
Patent expirations around 2030 may lead to the entry of generics, increasing competition, reducing prices, and potentially decreasing branded product revenues while expanding market volume.

4. Which regions are promising for future growth?
Emerging markets in Asia-Pacific, Latin America, and Africa offer substantial opportunities due to expanding healthcare infrastructure, increased cancer prevalence, and developing supportive care protocols.

5. How does competitive pressure influence pricing strategies?
Intense competition from generics and alternative therapies necessitates strategic pricing, value-based offerings, and potential innovation to maintain market share and profitability.

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References:

1. World Health Organization. (2022). Cancer fact sheet.
2. MarketsandMarkets. (2023). Anti-emetics market forecast.