FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for fosnetupitant chloride hydrochloride; palonosetron hydrochloride and what is the scope of freedom to operate?

Fosnetupitant chloride hydrochloride; 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.

Fosnetupitant chloride hydrochloride; palonosetron hydrochloride has one hundred and eighty-two patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

International Patents:	182
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
DailyMed Link:	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Dosage:

POWDER;INTRAVENOUS

^*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 FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AKYNZEO	Solution in SDV	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	235 mg/0.25 mg per 20 mL	210493	1	2022-04-19

US Patents and Regulatory Information for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; 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	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes			Y	Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes			Y	Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No			Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No				Y

International Patents for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Hungary	S2000032
Mexico	376118	FORMULACIONES INYECTABLES FISIOLÓGICAMENTE BALANCEADAS DE FOSNETUPITANT. (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Georgia, Republic of	P201706695	SUBSTITUTED 4-PHENYL-PYRIDI-NES FOR THE TREATMENT OF NK-1 RECEPTOR RELATED DISEASES
Poland	3435980

Supplementary Protection Certificates for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	C20200029 00371	Estonia		PRODUCT NAME: FOSNETUPITANT;REG NO/DATE: EU/1/15/1001; 18.03.2020
2785706	PA2020510	Lithuania		PRODUCT NAME: FOSNETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20200316
2785706	LUC00158	Luxembourg		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
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

Market Dynamics and Financial Trajectory for Fosnetupitant Chloride Hydrochloride and Palonosetron Hydrochloride

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for antiemetic agents, particularly Fosnetupitant Chloride Hydrochloride and Palonosetron Hydrochloride, has experienced significant shifts driven by advances in oncology supportive care, regulatory developments, and evolving clinical practices. These agents are pivotal in preventing chemotherapy-induced nausea and vomiting (CINV), a debilitating side effect that impacts patient quality of life and treatment adherence. This article examines the current market dynamics, competitive positioning, regulatory environment, and future financial trajectory of these drugs, providing insights crucial for stakeholders across the pharmaceutical value chain.

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Market Overview

Therapeutic Area and Clinical Demand

Chemotherapy-induced nausea and vomiting (CINV) remains formidable, despite advancements in cancer therapies. Effective management relies heavily on NK1 receptor antagonists such as Fosnetupitant and serotonin receptor antagonists like Palonosetron. The combined use of these agents is recognized as standard prophylaxis for moderate to high emetogenic risk chemotherapy.

The global market for antiemetics, especially those targeting CINV, has grown robustly—valued at approximately USD 1.4 billion in 2022—with projections to reach over USD 2 billion by 2030, registering a CAGR of about 6%. This growth correlates with increased cancer incidence rates and broader adoption of supportive care protocols. The dominant players are Western countries, but Asian markets notably expand due to rising cancer burdens and improved healthcare infrastructure [1].

Market Segmentation

• Drug Type: Selective NK1 receptor antagonists (Fosnetupitant) and 5-HT3 receptor antagonists (Palonosetron).
• Application: Chemotherapy-induced nausea and vomiting (CINV), Post-operative nausea and vomiting (PONV).
• Distribution Channel: Hospital pharmacies, specialty clinics, retail pharmacies.
• Geography: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.

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Fosnetupitant Chloride Hydrochloride: Market Dynamics

Pharmacological Profile and Clinical Positioning

Fosnetupitant serves as a prodrug of Netupitant, offering extended half-life and improved patient compliance due to single-dose efficacy. It is predominantly marketed within fixed-dose combination formulations (e.g., akynzeo), integrated with Palonosetron, providing comprehensive CINV management.

Regulatory Landscape

Approved primarily in Japan and the United States (as part of combination therapy), Fosnetupitant's regulatory recognition hinges on its efficacy and safety profile. The US FDA approved the combination (Netupitant + Palonosetron) under the brand Akynzeo in 2015. Japan’s PMDA approved Fosnetupitant for adjunctive use in 2020, reflecting regional regulatory maturation.

Market Drivers

• Clinical Efficacy: Superior nausea control, long duration of action allows for single-dose regimens [2].
• Competitive Edge: Single-dose convenience enhances patient adherence, especially in outpatient settings.
• Expansion in Oncology Care: The upward trend in high-dose chemotherapy protocols widens the patient pool.
• Strategic Partnerships: Licensing agreements with global pharmaceutical companies facilitate wider adoption [3].

Market Challenges

• Pricing and Reimbursement: High costs of combination regimens influence formulary decisions.
• Competition: Emergence of biosimilars and newer agents with similar efficacy may erode market share.
• Limited Global Footprint: Regulatory approvals outside Japan and US remain limited, constraining growth potential.

Financial Trajectory

Forecasts suggest Fosnetupitant’s global revenue to reach approximately USD 150-200 million annually by 2025, predominantly driven by North American and Japanese markets. Growth hinges on expanding indications, such as PONV, and gaining approvals in emerging markets. Entry into China and India could catalyze a significant revenue uptick given increasing cancer incidence [4].

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Palonosetron Hydrochloride: Market Dynamics

Pharmacological and Clinical Attributes

Palonosetron is a second-generation 5-HT3 receptor antagonist distinguished by its high receptor affinity and prolonged half-life (~40 hours), making it effective for both acute and delayed phase CINV. Its unique mechanism also reduces breakthrough nausea, favoring its frequent use in conjunction with NK1 antagonists.

Regulatory and Market Penetration

Palonosetron was approved by the FDA in 2008 and subsequently in other major markets. It is marketed widely across different healthcare settings, both as an injectable and oral formulation.

Market Drivers

• Proven Efficacy: Superior control over delayed CINV compared to first-generation agents [5].
• Market Positioning: As a recommended agent by multiple guidelines (e.g., NCCN, MASCC), Palonosetron has established strong clinical credibility.
• Pricing Strategies: Premium pricing justified by clinical benefits sustains margins despite competition.

Market Challenges

• Generic Competition: Multiple biosimilars and generics have entered the market, exerting downward pressure on prices.
• Alternative Drugs: Development of newer agents with comparable efficacy and cost advantages may threaten market share.
• Limited Use in PONV: While effective for CINV, its role in PONV remains less prominent, restricting market expansion.

Financial Outlook

Global sales of Palonosetron have been robust, with estimates placing revenues around USD 500-600 million in 2022. The compound's status as a standard-of-care agent ensures ongoing demand, though growth rates are anticipated to plateau as generics saturate markets. Post-patent expiry around 2024, market maturation is imminent, though branded formulations may persist due to clinical familiarity [6].

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Synergistic Market Dynamics

The combined use of Fosnetupitant (or other NK1 antagonists) with Palonosetron forms the backbone of modern CINV prophylaxis. The synergistic effect enhances efficacy, leading to improved patient outcomes and increased market volume. The uptake of fixed-dose combinations (FDCs) simplifies administration workflows, promoting adherence within outpatient oncology settings.

In parallel, expanding indications beyond CINV—such as PONV and anticipatory nausea—broadens the market scope. The introduction of biosimilars and generics for Palonosetron presents pricing pressure but also democratizes access, especially in emerging markets.

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Regulatory and Commercial Trends

Ongoing regulatory developments focus on expanding indications, simplifying dosing regimens, and streamlining approval pathways. Companies are also exploring novel formulations—such as sustained-release preparations—and combination pipelines to maintain competitive advantage.

Strategic partnerships, licensing arrangements, and pipeline diversification remain central strategies. Regional regulatory receptiveness and reimbursement policies will significantly influence the financial trajectory, especially in Asia-Pacific, Latin America, and Africa.

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Future Financial Trajectory

Based on current trends, the antiemetic market for Fosnetupitant and Palonosetron will continue growing, driven by:

• Increasing cancer prevalence: Projected to rise by over 50% in emerging markets by 2030.
• Advances in supportive care protocols: Adoption of guideline-recommended combinations.
• Regulatory approvals: Expansion into new territories may unlock unmet demand.

Forecasts indicate that while Palonosetron will likely sustain annual sales near USD 500-600 million through 2025, Fosnetupitant will experience accelerated growth in high-volume markets, potentially reaching USD 200 million by 2025 with sustained compound annual growth rates approximating 8-10%.

The trajectory will depend on successful market expansion, competitive positioning, and integration into broader oncology care pathways.

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Key Takeaways

• Market growth prospects: The antiemetics market is poised for steady expansion, with Fosnetupitant gaining increasing adoption in developed regions and emerging markets.
• Competitive landscape: While Palonosetron remains a market leader, generic entries will challenge pricing and profitability; Fosnetupitant’s niche as part of combination therapy offers a competitive edge.
• Regulatory environment: Continued approvals and label extensions will bolster market size; emerging markets present significant growth opportunities.
• Pipeline and innovation: Novel formulations and combination strategies will influence future market shares.
• Financial outlook: Revenue growth is sustainable, but heightens scrutiny on pricing, reimbursement policies, and clinical guidelines.

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FAQs

1. How does Fosnetupitant differ from other NK1 receptor antagonists?
Fosnetupitant, as a prodrug of Netupitant, offers prolonged receptor occupancy allowing for single-dose administration, which simplifies treatment regimens and enhances patient compliance compared to other NK1 antagonists like Aprepitant that require multiple doses.

2. What are the main advantages of Palonosetron over first-generation 5-HT3 antagonists?
Palonosetron features higher receptor affinity, longer half-life, and superior efficacy in preventing delayed CINV, making it preferable for extended prophylaxis, especially in high-risk chemotherapy regimens.

3. What regional factors influence market growth for these drugs?
Regulatory approvals, reimbursement policies, healthcare infrastructure, and cancer prevalence rates significantly influence growth. High-income countries have more mature markets, whereas Asia-Pacific and Latin America hold considerable expansion potential owing to rising cancer cases and improving healthcare access.

4. How will generic competition impact the revenues of Palonosetron post-patent expiry?
Generics will likely reduce prices and pressure branded revenues; however, brand loyalty, clinical efficacy, and physician familiarity can prolong branded formulations’ market presence, especially in institutional settings.

5. What emerging trends could disrupt the current market?
Innovations such as oral long-acting formulations, new receptor targets, and personalized antiemetic protocols based on genetic profiles could influence future market dynamics, emphasizing the need for ongoing R&D and strategic flexibility.

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References

[1] MarketsandMarkets, "Antiemetics Market Analysis," 2022.
[2] FDA Summary Basis of Approval, Akynzeo, 2015.
[3] Pharma Licensing News, "Strategic Alliances in Oncology Supportive Care," 2021.
[4] International Agency for Research on Cancer, "Global Cancer Statistics," 2020.
[5] NCCN Guidelines, "Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting," 2022.
[6] EvaluatePharma, "Palonosetron Market Trend," 2022.