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-one patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-nine 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 has been one patent litigation case 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:	189
US Patents:	21
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
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
Helsinn Healthcare SA	Phase 2
Simon Williamson Clinic	Phase 2
HK inno.N Corporation	Phase 1

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-three 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	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
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	10,624,911		Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	11,312,698		Y	Y
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes	9,943,515
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No	11,312,698		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	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

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
Malaysia	165514
European Patent Office	2361090	COMPOSITIONS POUR TRAITER LES NAUSÉES ET VOMISSEMENTS À MÉDIATION CENTRALE (COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING)
Italy	MI20000328
Lithuania	2785706
Moldova, Republic of	3435980
Poland	166272

Supplementary Protection Certificates for AKYNZEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	122020000046	Germany		PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
0430190	18/2005	Austria		PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
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
0430190	CA 2005 00023	Denmark
1035115	CR 2015 00044	Denmark		PRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150529
1035115	CA 2015 00044	Denmark		PRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150527

Market Dynamics and Financial Trajectory for AKYNZEO

Introduction

AKYNZEO, a fixed-dose combination of netupitant and palonosetron, is a significant player in the market for cancer chemotherapy-associated nausea and vomiting (CINV) therapeutics. This article delves into the market dynamics and financial trajectory of AKYNZEO, highlighting its efficacy, market share, financial performance, and future projections.

Efficacy and Clinical Significance

AKYNZEO has demonstrated strong efficacy in preventing both acute and delayed phases of CINV associated with highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). Clinical trials have shown that AKYNZEO achieves high complete response (CR) rates, with 83.2% of patients experiencing CR in the delayed phase and 92.9% in the acute phase during their first chemotherapy cycle[3].

Market Size and Growth

The global CINV therapeutics market, in which AKYNZEO is a key player, was valued at US$ 3,071.1 million in 2022 and is projected to reach US$ 4,521.7 million by 2030, growing at a CAGR of 5.7%[4].

Regional Dominance

North America holds a dominant position in this market, accounting for 44.6% of the global share. This dominance is partly due to the increasing adoption of inorganic strategies such as distribution and supply agreements by key players in the region[4].

Distribution and Licensing Agreements

Knight Therapeutics Inc. and Helsinn Healthcare SA have entered into an exclusive license, distribution, and supply agreement for AKYNZEO in several countries, including Canada, Brazil, Argentina, Uruguay, and Paraguay. This agreement has significantly expanded the drug's reach and market potential[4].

Financial Performance

Revenue and Gross Margin

The financial performance of companies distributing AKYNZEO, such as Knight Therapeutics, reflects the drug's market impact. For instance, Knight Therapeutics reported revenues of $328,199 in 2023, an increase of 12% from the previous year. The gross margin also saw an increase, reaching $152,652, which is a 11% rise from the previous year[2].

Operating Expenses and EBITDA

Despite the increase in revenues and gross margin, operating expenses have also risen, driven by higher research and development expenses. For the year ended December 31, 2023, adjusted EBITDA increased by $6,043 or 11%, but this was offset by increased expenses in sales and marketing, general and administrative, and research and development activities[2].

Cost-Effectiveness and Pharmacoeconomic Analysis

Pharmacoeconomic analyses have shown mixed results regarding the cost-effectiveness of AKYNZEO. In patients receiving HEC, AKYNZEO was found to be dominant compared to other regimens, offering additional benefits at less cost. However, in patients receiving MEC, the incremental cost-utility ratios (ICURs) were significantly higher, ranging from $270,094 to $316,082 per quality-adjusted life-year (QALY) gained compared to other treatments[1].

Price Sensitivity

The high cost of AKYNZEO is a significant factor affecting its market dynamics. The average retail price of one capsule of AKYNZEO is around US$ 570.8, which can be a barrier to adoption. A price reduction of 45% to 65% would be necessary for AKYNZEO to achieve an ICUR of $50,000 per QALY in patients receiving MEC[1][4].

Market Drivers and Challenges

Drivers

• Rising Cancer Prevalence: The increasing number of cancer cases drives the demand for CINV therapeutics.
• Distribution Agreements: Exclusive licensing and distribution agreements expand the drug's market reach.
• Efficacy: High CR rates in both acute and delayed phases of CINV[3][4].

Challenges

• High Cost: The expensive nature of AKYNZEO and other CINV treatment drugs can hinder market growth.
• Regulatory Considerations: Changes in guidelines and classifications of chemotherapy regimens can impact the drug's efficacy and cost-effectiveness[1][4].

Future Projections

Given the projected growth of the CINV therapeutics market and the strategic distribution agreements in place, AKYNZEO is poised to maintain its significant market share. However, addressing the high cost and ensuring cost-effectiveness will be crucial for sustained market dominance.

Key Takeaways

• Efficacy: AKYNZEO demonstrates high CR rates in preventing CINV.
• Market Size: The global CINV therapeutics market is growing, with North America holding a dominant share.
• Financial Performance: Revenues and gross margins are increasing, but so are operating expenses.
• Cost-Effectiveness: AKYNZEO is cost-effective in HEC but less so in MEC, requiring potential price adjustments.
• Market Dynamics: Distribution agreements and rising cancer prevalence drive market growth, while high costs pose challenges.

FAQs

What is AKYNZEO used for?

AKYNZEO is used in combination with dexamethasone for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC)[1].

How effective is AKYNZEO in preventing CINV?

AKYNZEO achieves high complete response rates, with 83.2% of patients experiencing CR in the delayed phase and 92.9% in the acute phase during their first chemotherapy cycle[3].

What is the average retail price of AKYNZEO?

The average retail price of one capsule of AKYNZEO is around US$ 570.8[4].

Which regions dominate the market for CINV therapeutics?

North America holds a dominant position in the global CINV therapeutics market, accounting for 44.6% of the market share[4].

What are the key challenges facing AKYNZEO in the market?

High costs and the need for price adjustments to achieve cost-effectiveness in certain patient populations are significant challenges[1][4].

Sources

1. CADTH COMMON DRUG REVIEW Pharmacoeconomic Review Report for Akynzeo
2. Knight Therapeutics Reports Fourth Quarter and Year-End 2023 Results
3. FDA Clinical Review for Akynzeo
4. Cancer Chemotherapy Associated Nausea and Vomiting Therapeutics Market by Coherent Market Insights
5. Knight Therapeutics Reports Fourth Quarter and Year-End 2022 Results