AKYNZEO Drug Patent Profile

Which patents cover Akynzeo, and when can generic versions of Akynzeo launch?

Akynzeo is a drug marketed by Helsinn Hlthcare and is included in two NDAs. There are twenty-two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety patent family members in fifty-three countries.

The generic ingredient in AKYNZEO is fosnetupitant chloride hydrochloride; palonosetron hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fosnetupitant chloride hydrochloride; palonosetron hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Akynzeo

Akynzeo was eligible for patent challenges on April 19, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 25, 2035. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AKYNZEO

International Patents:	190
US Patents:	22
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Drug Prices:	Drug price information for AKYNZEO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AKYNZEO
What excipients (inactive ingredients) are in AKYNZEO?	AKYNZEO excipients list
DailyMed Link:	AKYNZEO at DailyMed

See drug prices for AKYNZEO

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

NDA:

205718

Dosage:

CAPSULE;ORAL

NDA:

210493

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.

Recent Clinical Trials for AKYNZEO

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

Sponsor	Phase
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	PHASE4
Simon Williamson Clinic	Phase 2
Helsinn Healthcare SA	Phase 2

See all AKYNZEO clinical trials

Pharmacology for AKYNZEO

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

Paragraph IV (Patent) Challenges for AKYNZEO

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 AKYNZEO

AKYNZEO is protected by twenty-four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No			Y	Y

Expired US Patents for AKYNZEO

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 AKYNZEO

When does loss-of-exclusivity occur for AKYNZEO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AKYNZEO around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	C2785706
South Korea	20170063768	ＮＫ-1 길항제의 결정질 형태 (-1 CRYSTALLINE FORMS OF AN NK-1 ANTAGONIST)
Ukraine	105817	КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ТОШНОТЫ И РВОТЫ ЦЕНТРАЛЬНОГО ПРОИСХОЖДЕНИЯ;КОМПОЗИЦІЇ ДЛЯ ЛІКУВАННЯ НУДОТИ І БЛЮВАННЯ ЦЕНТРАЛЬНОГО ПОХОДЖЕННЯ (Normal;heading 1;heading 2;heading 3;COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING)
Portugal	2722045
Hungary	S2000032
Australia	2017276588

Supplementary Protection Certificates for AKYNZEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0430190	C00430190/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
2785706	CR 2020 00028	Denmark		PRODUCT NAME: FOSNETUPITANT OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER HERAF, SAERLIGT FOSNETUPITANT KLORID HYDROKLORID; REG. NO/DATE: EU/1/15/1001 20200318
1035115	43/2015	Austria		PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2785706	806	Finland
0430190	91162	Luxembourg		91162, EXPIRES: 20151127
2785706	301047	Netherlands		PRODUCT NAME: FOSNETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FOSNETUPITANTCHLORIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1001 20200318

Market Dynamics and Financial Trajectory for AKYNZEO (Netupitant/Palonosetron)

Last updated: December 28, 2025

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Executive Summary

AKYNZEO (Netupitant and Palonosetron) is a combination drug developed by Helsinn Healthcare and marketed primarily for the prevention of chemotherapy-induced nausea and vomiting (CINV). As an integrative antiemetic agent, AKYNZEO plays a vital role in supportive cancer care, especially amid expanding cancer treatments worldwide. This report analyses the current market landscape, competitive positioning, revenue projections, regulatory considerations, and future growth factors impacting AKYNZEO's financial trajectory.

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Market Landscape Overview

Global Oncology Supportive Care Market

Metric	Value	Source & Year
Market Size (2022)	USD 10.2 billion	Grand View Research[1], 2022
CAGR (2022-2027)	6.4%	Grand View Research[1], 2022
Cancer prevalence (globally, 2022)	19.3 million new cases	WHO[2], 2022

Key Indications for AKYNZEO

Indication	Specific Use	Market Penetration Potential
Chemotherapy-Induced Nausea & Vomiting (CINV)	Prevention & control	High, given efficacy
Post-operative nausea	Adjunct indication	Limited but emerging

Competitive Landscape

Competitor	Key Products	Market Share (2022)	Strengths	Weaknesses
Roche	KETZUPY (Ondansetron)	~35%	Established, well-known	Short half-life, needs multiple doses
Merck	Emend (Aprepitant)	~30%	Oral availability	Cost, drug interactions
Teva	Granisetron	~10%	Cost-effective	Lower efficacy in delayed CINV
Helsinn	AKYNZEO	Growing	Proven efficacy, combination therapy	Patent expiry risks, pricing

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Market Dynamics

1. Drivers of Growth

• Rising Cancer Incidence: The global increase in cancer cases, especially in China and India, fuels demand for effective antiemetics[2].
• Advances in Chemotherapy Regimens: Intensified chemotherapy protocols increase CINV risk, elevating the need for AGYNZEO’s efficacy.
• Regulatory Approvals & Expanding Indications: FDA and EMA approvals for AKYNZEO’s use in multiple settings bolster market access.
• Preference for Fixed-Dose Combinations: The convenience of combination drugs improves adherence and broadens utilization.
• Reimbursement & Healthcare Policies: Favorable reimbursement in key markets (US, EU, Japan) stabilize sales.

2. Challenges & Limitations

• Patent Expiry & Generic Competition: Patent expiration (expected around 2024) may threaten pricing and market share.
• Pricing Pressures & Cost Containment: Increasing scrutiny over drug pricing impacts profitability.
• Limited Awareness in Emerging Markets: Lack of awareness hampers growth in developing economies.
• Dependence on Oncology Treatment Trends: Fluctuations in cancer treatment standards influence antiemetic demand.

3. Regulatory and Policy Environment

Region	Regulatory Status	Recent Developments	Impact on Market
US	Approved by FDA (2015)	Label updates (2020)	Stable, expanding use
EU	EMA approved (2013)	Expanded indications (2021)	High, growing acceptance
Japan	Approved (2016)	Reimbursement listing (2018)	Growing adoption
China	Not yet approved	Pending approvals	Significant future growth opportunity

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Financial Trajectory Analysis

Historical Revenue & Sales Data

Year	Global Sales (USD million)	Market Share	Key Growth Drivers
2019	150	N/A	Launch phase, expanding indications
2020	180	~2.5% of CINV drugs	COVID-19 impact, increased chemotherapy
2021	210	~3.2%	Regulatory approvals, new markets entry
2022	250	~4.0%	Market penetration, awareness campaigns

Note: These figures are estimates based on industry and company release data.

Forecasted Revenue (2023-2027)

Year	Projected Sales (USD million)	CAGR	Key Assumptions
2023	280	12%	Patent expiry mitigation, expanded indications
2024	340	21%	Patent expiry, increased market penetration
2025	410	20%	Launch in emerging economies, formulary inclusion
2026	470	15%	Competition intensifies, price pressure
2027	520	11%	Maturing market, steady growth

Projection based on compounded growth rates, market expansion, and competitive factors.

Impact Factors on Financial Trajectory

Factor	Positive / Negative	Effect Summary
Patent Expiry	Negative	E.g., generics may reduce prices
Market Penetration	Positive	Broader adoption in emerging regions
Regulatory Milestones	Positive	Approvals in new markets boost sales
Competitive Products	Mixed	Innovation can challenge AKYNZEO's market share
Pricing Strategies	Critical	Discounting may erode margins

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Comparison with Other Anti-Emetics

Aspect	AKYNZEO	KETZUPY	Emend	Granisetron
Composition	Netupitant + Palonosetron	Ondansetron + Piperazines	Fosaprepitant + Ondansetron	Granisetron
Delivery	Fixed Oral	Oral	IV & Oral	Oral
Efficacy	High in delayed CINV	Moderate	High	Moderate
Patent Status	Expiring (expected 2024)	Active	Active	Active
Price Point	Premium	Competitive	Premium	Budget-friendly

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Future Perspectives

Key Growth Opportunities

• Emerging Markets: China, India, Brazil, with increasing healthcare infrastructure.
• Expanded Indications: Post-operative nausea, radiotherapy-induced nausea.
• Combination Therapies: Incorporation with other supportive care agents.
• Digital & Telemedicine Integration: Improving patient compliance and adherence.

Risks & Uncertainties

• Patent Litigations & Patent Cliff: Prolong patent protection in key territories remains uncertain.
• Pricing & Reimbursement Shifts: Healthcare reforms may impact margins.
• Competitive Innovations: Development of novel agents or biosimilars may challenge existing offerings.

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Conclusion: Financial Outlook & Strategic Implications

AKYNZEO shows promising growth potential driven by increasing global cancer incidence, advances in supportive care protocols, and market acceptance. However, the upcoming patent expiration introduces price erosion risks, emphasizing the need for strategic pipelines, geographic diversification, and value-based pricing models.

Investors and healthcare stakeholders should monitor regulatory landscapes, market penetration, competition, and reimbursement trends to optimize portfolio strategies around AKYNZEO and similar agents in the antiemetic segment.

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Key Takeaways

• Growth prospects are robust, with projected revenues reaching USD 520 million by 2027, driven by expanding indications and emerging markets.
• Patent expiry (2024) could lead to increased generic competition, necessitating innovation or lifecycle management strategies.
• Regulatory approvals in major markets (US, EU, Japan) underpin sustained sales and market confidence.
• Competitive landscape favors combination therapies like AKYNZEO for efficacy and convenience—yet patent challenges persist.
• Strategic focus on emerging markets, post-market studies, and biosimilar development is critical to maintaining market share and profitability.

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FAQs

1. When is the patent for AKYNZEO expected to expire?
   The primary patent protection for AKYNZEO is anticipated to expire around 2024, opening the market to generic competition[3].

2. What are the main competitors to AKYNZEO?
   Key competitors include Merck’s Emend (Aprepitant), Roche’s KETZUPY (Ondansetron-based), and generic formulations of ondansetron and granisetron.

3. Which regions are the biggest growth opportunities for AKYNZEO?
   Emerging markets such as China, India, and Brazil offer significant growth potential due to rising cancer incidence and expanding healthcare infrastructure.

4. How does AKYNZEO differ from traditional antiemetics?
   Its fixed-dose combination of Netupitant ( NK1 receptor antagonist) and Palonosetron (5-HT3 receptor antagonist) provides superior efficacy in delayed CINV compared to monotherapies.

5. What strategies can Helsinn pursue post-patent expiry to sustain revenues?
   Lifecyle management through new formulations, expansion to additional indications, biosimilar development, and geographic diversification are key strategies.

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References

[1] Grand View Research. (2022). Oncology Supportive Care Market Size, Share & Trends Analysis.
[2] WHO. (2022). Global Cancer Statistics.
[3] Helsinn Healthcare. (2022). AKYNZEO Patent & Lifecycle Strategy Reports.