AKYNZEO Drug Patent Profile

When do Akynzeo patents expire, and what generic alternatives are available?

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
Helsinn Healthcare SA	Phase 2
Simon Williamson Clinic	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

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
Philippines	12014501199
Taiwan	201331181	Modified 4-phenyl-pyridine derivatives
Denmark	2361090
European Patent Office	1394150	Dérivés de 4-phenylpyridine et leur utilisation comme antagonistes du recepteur NK-1 (4-Phenylpyridine derivatives and their use as NK-1 receptor antagonists)
Costa Rica	20120216

Supplementary Protection Certificates for AKYNZEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1035115	PA2015036,C1035115	Lithuania		PRODUCT NAME: NETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2785706	CA 2020 00028	Denmark		PRODUCT NAME: FOSNETUPITANT OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER HERAF, SAERLLIGT FOSNETUPITANT KLORID HYDROKLORID; REG. NO/DATE: EU/1/15/1001 20200318
2785706	2020030	Norway		PRODUCT NAME: FOSNETUPITANT OG FARMASOEYTISK AKSEPTABLE SALTER OG SOLVATER DERAV SPESIELT FOSNETUPITANT KLORID HYDROKLORID; REG. NO/DATE: EU/1/15/1001 20200318
1035115	PA2015036	Lithuania		PRODUCT NAME: NETUPITANTUM; REGISTRATION NO/DATE: EU/1/15/1001 20150527
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

Market Dynamics and Financial Trajectory for AKYNZEO

Last updated: July 27, 2025

Introduction

AKYNZEO (netupitant and palonosetron) represents a significant advancement in antiemetic therapy, primarily aimed at preventing nausea and vomiting associated with chemotherapy. As an integrated combination of a neurokinin-1 (NK1) receptor antagonist and a serotonin (5-HT3) receptor antagonist, AKYNZEO has penetrated a rapidly evolving oncology supportive care market. Understanding its market dynamics and financial progression involves analyzing regulatory approvals, competitive landscape, market adoption, pricing strategies, and future growth drivers.

Regulatory Approvals and Market Entry

Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2014, AKYNZEO has secured regulatory approvals across major markets including the European Union, Japan, and Canada. The drug's approval was predicated on clinical trials demonstrating superior efficacy over monotherapy options in preventing chemotherapy-induced nausea and vomiting (CINV), particularly in highly emetogenic regimens [[1]]. Regulatory endorsements established AKYNZEO as a preferred regimen in antiemetic guidelines, directly influencing market penetration.

Competitive Landscape

The antiemetic segment is characterized by a mix of branded and generic products. In particular, drugs such as ondansetron, granisetron, and aprepitant have historically dominated the segment. AKYNZEO's main competitors include:

• Aprepitant (Emend): An oral NK1 receptor antagonist with widespread adoption.
• Palonosetron (Aloxi): The 5-HT3 antagonist component, with proven efficacy.

However, AKYNZEO's fixed-dose combination optimizes treatment adherence and simplifies dosing schedules, offering a competitive edge. The combination's efficacy and safety profile also position it favorably in clinical practice guidelines [[2]].

Market Adoption and Usage Trends

Since its launch, AKYNZEO has experienced steady growth driven by:

• Guideline Endorsements: The NCCN and ASCO guidelines endorse AKYNZEO for highly emetogenic chemotherapy, enhancing prescriber confidence.
• Physician Preference: The convenience of a fixed-dose oral and IV formulation encourages adoption, especially in outpatient settings.
• Patient Compliance: Simplified dosing improves compliance, lowering the risk of breakthrough nausea, which is both clinically beneficial and economically advantageous.

Despite these drivers, adoption varies across regions, influenced by factors such as healthcare infrastructure, reimbursement policies, and clinician familiarity.

Pricing Strategy and Reimbursement Landscape

Price points for AKYNZEO are positioned as premium, reflecting its clinical benefits and novel combination formulation. Payer reimbursement policies significantly influence market penetration; favorable formulary placement and coverage boost sales, while high out-of-pocket costs can impede uptake. In the U.S., negotiations with insurers and inclusion in Medicare Part D formularies are pivotal.

In markets like Europe and Japan, reimbursement policies are more centralized, often requiring negotiation through health authorities. The drug’s cost-effectiveness, supported by clinical benefits and reduced hospitalizations due to uncontrolled nausea, fosters favorable reimbursement decisions [[3]].

Financial Trajectory and Revenue Growth

AbbVie and Helsinn, the primary marketing partners, report incremental revenue growth from AKYNZEO, aligned with market expansion. Key financial indicators include:

• Revenue Trajectory: Post-launch, annual revenues increased as adoption expanded; however, growth pace aligns with the competitive landscape.
• Pricing Influence: Premium pricing sustains margins but limits volume growth compared to generics.
• Market Expansion: Entry into new territories and developing markets amplifies revenue streams, albeit with shorter-term regulatory and market access hurdles.

Forecast models project a compound annual growth rate (CAGR) in the range of 5-10%, contingent upon competitive pressures, patent life, and pipeline developments.

Future Market Drivers

Several factors are likely to shape AKYNZEO’s future market landscape:

• Pipeline and Formulation Innovations: Development of alternative formulations, including biosimilar versions, could introduce price competition but also expand market access.
• Oncology Treatment Trends: The increasing prevalence of chemotherapy and the advent of immunotherapy combinations elevate the need for effective antiemetics.
• Regulatory Approvals for New Indications: Expanded approval for additional chemotherapy regimens or prophylactic uses could broaden market potential.
• Competitive Innovations: Next-generation NK1 or 5-HT3 antagonists and novel antiemetic agents could challenge AKYNZEO’s market share.

Summary of Market Challenges and Opportunities

While AKYNZEO benefits from clinical efficacy and guideline endorsements, it faces challenges including high pricing, competitors with entrenched market presence, and potential patent expirations. Opportunities lie in expanding indications, strategic alliance formations, and targeted pricing strategies to penetrate emerging markets.

Key Takeaways

• Strategic Positioning: AKYNZEO's fixed-dose combination offers clinical and adherence advantages, supporting its ongoing market adoption.
• Market Growth: Revenue growth is sustainable but moderated by competitive drugs, with regional expansion being a critical driver.
• Pricing and Reimbursement: Navigating reimbursement landscapes remains integral, especially in price-sensitive markets.
• Pipeline and Innovation: Pipeline developments and formulary expansions could influence future market share and financial performance.
• Competitive Threats: Emergence of biosimilars or next-generation antiemetics could pressure pricing and margins.

FAQs

Q1: How does AKYNZEO’s combination therapy improve patient outcomes over monotherapies?

A1: AKYNZEO combines a potent NK1 receptor antagonist with a 5-HT3 receptor antagonist, providing superior prophylaxis against both acute and delayed CINV. This synergy reduces the incidence of breakthrough nausea and vomiting, improving patient quality of life and treatment adherence [[2]].

Q2: What factors limit AKYNZEO’s market penetration?

A2: Key limitations include high drug costs, competition from established generic antiemetics, variability in reimbursement policies, and clinician familiarity with existing regimens. Patent expiration timelines will also influence generic entry.

Q3: Are there impending regulatory approvals or new indications for AKYNZEO?

A3: Currently, no major new indications have been announced, but ongoing clinical trials exploring broader prophylactic uses and new formulations could lead to future approvals, expanding its market.

Q4: How significant is the role of pricing in AKYNZEO’s financial success?

A4: Pricing significantly impacts revenue; premium pricing reflects clinical benefits but can hinder volume growth, especially in price-sensitive regions. Strategic pricing aligned with reimbursement negotiations is crucial for sustained growth.

Q5: What is the outlook for AKYNZEO in emerging markets?

A5: While growth is promising due to increasing cancer incidence, market entry depends on regulatory approvals, pricing strategies, and healthcare infrastructure. Collaborations with local distributors can facilitate access.

References

1. Helsinn Healthcare SA. "AKYNZEO (netupitant and palonosetron) Summary of Product Characteristics." 2014.
2. Gralla RJ, et al. "Efficacy of AKYNZEO for Prevention of Chemotherapy-Induced Nausea and Vomiting." Journal of Clinical Oncology. 2015.
3. National Comprehensive Cancer Network (NCCN). "Antiemesis Guidelines," 2022.