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 eleven 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 patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

International Patents:	180
US Patents:	11
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

Constraining patent/regulatory exclusivity:

10,624,911

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	10,208,073
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	9,186,357
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No	9,186,357
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	9,403,772			Y

International Patents for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	2018015036	FORMULACIONES INYECTABLES FISIOLOGICAMENTE BALANCEADAS DE FOSNETUPITANT. (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT.)
South Africa	201404787
Taiwan	I725191
Israel	263126	פורמולציות להזרקה של פוסנטופיטנט המאוזנות פיזיולוגית (Physiologically balanced injectable formulations of fosnetupitant)
China	111662330	用于治疗NK-1受体相关疾病的取代的4-苯基吡啶 (Substituted 4-phenyl pyridines for treatment NK-1 receptor related diseases)

Supplementary Protection Certificates for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2785706	PA2020510,C2785706	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	SPC/GB20/037	United Kingdom		PRODUCT NAME: FOSNETUPITANT; REGISTERED: UK EU/1/15/1001 (NI) 20200318; UK PLGB 12333/0017-0001 20200318
2785706	2020C/516	Belgium		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE Market Analysis and Financial Projection Experimental

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

Introduction

The combination of fosnetupitant chloride hydrochloride and palonosetron hydrochloride, commonly known as AKYNZEO®, has revolutionized the treatment of chemotherapy-induced nausea and vomiting (CINV). This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this drug combination.

Mechanism of Action

Fosnetupitant, a water-soluble phosphorylated pro-drug of netupitant, rapidly converts to netupitant in vivo, which selectively antagonizes human substance P/NK1 receptors. Palonosetron, on the other hand, is a selective 5-HT3 receptor antagonist with a strong binding affinity for this receptor. Together, they target two critical pathways associated with acute and delayed CINV, providing comprehensive antiemetic coverage[4].

Market Size and Growth

The global netupitant–palonosetron FDC market, which includes AKYNZEO®, has seen significant growth. In 2015, the market was valued at $257,162 million and is estimated to reach $527,187 million by 2022, growing at a CAGR of 10.8% during the forecast period. This growth is driven by the increasing number of patients undergoing chemotherapy and the need for more effective antiemetic treatments[1].

Geographic Segmentation

Geographically, the market is segmented into North America, Europe, Asia-Pacific, and LAMEA. North America has been the dominant regional market due to the high incidence of CINV among patients, followed by Europe. The approval of new drugs such as rolapitant and Sustol in the US market has further boosted the growth in these regions[1].

Patient Pool and Adoption

The patient pool segment has witnessed large-scale adoption of netupitant-palonosetron FDC drugs. The rise in the number of patients undergoing chemotherapy and the introduction of novel delivery methods to improve patient compliance have contributed to this adoption. The efficacy of combination therapy, particularly in treating highly emetogenic cytotoxic drugs, has been a key driver[1].

Technological Advancements

Technological advancements play a crucial role in the market growth. Companies are seeking new technologies to lower production costs and discover new products. For instance, the development of rolapitant (Varubi) by Tesaro has gained significant traction in the CINV drugs segment. Similarly, the introduction of needle-free, painless, and cost-effective transdermal drug delivery systems is expected to increase demand[1].

Competitive Landscape

The market is competitive, with major players such as Helsinn Holding S.A., Heron Therapeutics, Inc., and Eisai Pharmaceutical Pvt Ltd. These companies are adopting strategies to sustain a competitive environment and increase their market share. Helsinn, for example, has a strong focus on oncology and rare diseases, with over forty years of commercial execution[1][5].

Financial Impact and Healthcare Costs

Real-world evidence published in the journal Advances in Therapy has shown that AKYNZEO® (fosnetupitant with palonosetron) has a positive impact on treatment outcomes and healthcare costs. The data indicates that the use of AKYNZEO® can lead to better patient outcomes and reduced healthcare costs associated with CINV management[5].

Market Segmentation

The market is segmented based on patient pool type and geography. The palonosetron hydrochloride market is also categorized by application (injection, oral capsule) and product purity (≥98%, ≥99%). These segmentations help in understanding the diverse market dynamics and opportunities[1][2].

Drivers and Restraints

Key drivers of the market include the increasing incidence of CINV, the need for more effective antiemetic treatments, and technological advancements in drug delivery systems. However, factors such as variability in genes encoding enzymes and proteins related to antiemetic drugs, which can lead to suboptimal response rates, act as restraints. Additionally, the high production costs and regulatory hurdles can also impact market growth[1].

Future Outlook

The palonosetron hydrochloride market is expected to continue its growth trajectory from 2023 to 2031, with a CAGR of 3 to 5%. The comprehensive assessment of market dynamics, including drivers, restraints, opportunities, and challenges, indicates a consistent upward trend in market growth. The introduction of new delivery methods and the approval of new drugs will further drive this growth[2].

Key Takeaways

• The global netupitant–palonosetron FDC market is projected to grow significantly, driven by the increasing incidence of CINV and the need for effective treatments.
• Technological advancements and novel delivery methods are key drivers of market growth.
• Geographic segmentation shows North America and Europe as dominant markets.
• Major players are adopting competitive strategies to increase market share.
• Real-world evidence indicates positive impacts on treatment outcomes and healthcare costs.

FAQs

What is the mechanism of action of fosnetupitant and palonosetron?

Fosnetupitant converts to netupitant, which antagonizes human substance P/NK1 receptors, while palonosetron is a selective 5-HT3 receptor antagonist, together targeting pathways associated with CINV[4].

Which regions dominate the netupitant–palonosetron FDC market?

North America and Europe are the dominant regional markets due to the high incidence of CINV among patients[1].

What are the key drivers of the netupitant–palonosetron FDC market?

Key drivers include the increasing incidence of CINV, the need for more effective antiemetic treatments, and technological advancements in drug delivery systems[1].

How does AKYNZEO® impact healthcare costs?

Real-world evidence indicates that AKYNZEO® leads to better patient outcomes and reduced healthcare costs associated with CINV management[5].

What is the projected growth rate of the palonosetron hydrochloride market?

The palonosetron hydrochloride market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031[2].

Sources

1. Allied Market Research - Netupitant – Palonosetron FDC Market Size - Analysis 2022
2. Market Research Intellect - Palonosetron Hydrochloride Market Size and Forecast
3. Market Research Intellect - Palonosetron Hydrochloride Injection Market Size, Scope And Forecast
4. Australian Government Department of Health - Australian public assessment report for Fosnetupitant (as chloride) hydrochloride - Palonosetron hydrochloride
5. BioSpace - Helsinn announces publication of data evaluating impact of AKYNZEO® (fosnetupitant/palonosetron) on treatment outcomes and healthcare costs