AKYNZEO Drug Patent Profile

Which patents cover Akynzeo, 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-two 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:	192
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

Constraining patent/regulatory exclusivity:

9,951,016

NDA:

205718

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,624,911

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.

This potential generic entry date is based on patent 9,951,016.

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	9,908,907		Y	Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	10,208,073
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	8,426,450		Y	Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	10,828,297

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	5,202,333
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014	6,297,375

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

Georgia, Republic of

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
Mexico	2014006423
China	104856999	Compositions for treating centrally mediated nausea and vomiting
Norway	905120
Lithuania	PA2020510

Supplementary Protection Certificates for AKYNZEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	PA2020510	Lithuania		PRODUCT NAME: FOSNETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20200316
1035115	C01035115/01	Switzerland		PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015
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	92745	Luxembourg		PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527

Market Dynamics and Financial Trajectory for AKYNZEO

Last updated: March 9, 2026

What is the current market position of AKYNZEO?

AKYNZEO (netupitant with palonosetron) is a combination drug approved by the FDA in December 2014 for preventing nausea and vomiting caused by chemotherapy. It targets the chemotherapy-induced nausea and vomiting (CINV) market segment.

In 2022, the drug generated approximately $79 million in U.S. sales, marking a steady growth from $60 million in 2020. Globally, sales are estimated around $125 million, with potential to expand as indications broaden.

How does AKYNZEO compare to its competitors?

• Primary competitor: Emend (fosaprepitant/aprepitant), with global sales exceeding $1 billion annually.
• Market share: AKYNZEO holds an estimated 5-7% share of the antiemetic market segment.
• Pricing: Average wholesale price (AWP) per dose stands at approximately $350, with pricing variations based on healthcare setting and payer negotiations.

What are the key market drivers?

1. Rising chemotherapy use: An increase in cancer diagnoses (projected to reach 21.7 million new cases globally by 2040) creates higher demand for antiemetics.
2. Expanding indications: Current approved for highly and moderately emetogenic chemotherapy. Future approvals for other chemotherapy regimens could stimulate sales.
3. Shift towards oral administration: AKYNZEO's oral formulation offers a more convenient option, improving adherence.

What are the significant challenges?

• Generic competition: As patent exclusivity expires, generic versions of similar drugs could erode market share.
• Price pressure: Payers and hospitals seek cost-effective alternatives, pressuring list prices.
• Regulatory hurdles: Potential for additional indications and label expansions depends on clinical trial outcomes.

What is the projected financial trajectory?

Analysts estimate the global antiemetic market will grow at a compound annual growth rate (CAGR) of 4-6% until 2030.

• Short-term: US sales are expected to grow 8-10% annually through 2025 driven by increased adoption.
• Mid-term: Entry into new markets and broader indications could double total sales by 2030, reaching approximately $250 million annually.
• Long-term: Patent expiration (anticipated around 2027-2028) may result in a sharp decline unless lifecycle management strategies, such as label expansion or combination therapies, succeed.

Key factors influencing future revenue

Factor	Impact	Timeline
New clinical approvals	Potential to expand indications and sales	2024-2026
Patent cliff	Risk of generic entry post-2028	2027-2028
Market penetration strategies	Higher adoption rates in emerging markets	2023-2025
Pricing and reimbursement policies	Cost pressures may limit pricing power	2023-2025

Conclusion

AKYNZEO's market well-positioned within the antiemetic segment, with stable sales growth driven by increasing chemotherapy utilization and convenience factors. However, the impending patent expiry and competitive landscape require strategic planning to sustain revenue gains. The prospects hinge on regulatory decisions, market expansion, and pricing dynamics.

Key Takeaways

• US sales of AKYNZEO reached $79 million in 2022, with steady growth projected.
• The global antiemetic market grows 4-6% annually, expected to support incremental sales increases.
• Patent expiration around 2027-2028 risks market share erosion, requiring lifecycle management.
• Clinical approval for additional indications and strategic market expansion could double mid-term sales.
• Price competition and generic entry remain significant hurdles.

FAQs

1. When does the patent for AKYNZEO expire, and how does it impact sales?
Patent expiry is expected around 2027-2028, risking generic competition that could significantly reduce sales unless offset by new indications or formulations.

2. Are there ongoing clinical trials for additional indications of AKYNZEO?
Yes, trials are underway exploring its efficacy in preventing nausea from other chemotherapies, which may lead to label expansions.

3. How does AKYNZEO compare cost-effectively to competitor products?
Pricing is comparable but subject to payer negotiations. Its oral formulation provides some adherence advantages over injectable alternatives.

4. What regional markets offer growth opportunities?
Emerging markets such as China, India, and Latin America show expanding oncology treatment regions that could boost sales if regulatory hurdles are cleared.

5. How might new therapies impact AKYNZEO’s market share?
Introduction of more effective or lower-cost antiemetics, especially generic options, could compress AKYNZEO's market share unless it gains expanded indications or improved formulations.

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References

[1] EvaluatePharma. (2022). Pharmaceutical sales data.
[2] IQVIA. (2022). Global Oncology Market Report.
[3] U.S. Food and Drug Administration. (2014). FDA approval for AKYNZEO.
[4] Research and Markets. (2023). Anti-Emetic Market Forecasts.