ALOXI Drug Patent Profile

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

Aloxi is a drug marketed by Helsinn Hlthcare and is included in two NDAs.

The generic ingredient in ALOXI is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aloxi

A generic version of ALOXI was approved as palonosetron hydrochloride by SANDOZ on October 13^th, 2015.

Summary for ALOXI

US Patents:	0
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALOXI

Paragraph IV (Patent) Challenges for ALOXI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALOXI	Injection	palonosetron hydrochloride	0.05 mg/mL, 1.5 mL and 5 mL vials	021372	3	2011-05-27

US Patents and Regulatory Information for ALOXI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	CAPSULE;ORAL	022233-001	Aug 22, 2008		DISCN	Yes	No
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No

International Patents for ALOXI

See the table below for patents covering ALOXI around the world.

Country	Patent Number	Title	Estimated Expiration
Morocco	27710	FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE
Norway	175309
Canada	2573194	FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)
Australia	6696390
Japan	5551658
Hungary	907660

Supplementary Protection Certificates for ALOXI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0430190	300194	Netherlands		300194, 20101127, EXPIRES: 20151126
2785706	2020C/516	Belgium		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706	202040035	Slovenia		PRODUCT NAME: FOSNETUPITANT/PALONOSETRON; NATIONAL AUTHORISATION NUMBER: EU/1/15/1001; DATE OF NATIONAL AUTHORISATION: 20200316; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2785706	C02785706/01	Switzerland		PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
0430190	91162	Luxembourg		91162, EXPIRES: 20151127
0430190	18/2005	Austria		PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322

ALOXI Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

What is ALOXI?

ALOXI (palonosetron hydrochloride) is a serotonin 5-HT3 receptor antagonist indicated primarily for preventing chemotherapy-induced nausea and vomiting (CINV). Marketed by TerSera Pharmaceuticals in the US and by Helsinn Healthcare in other regions, ALOXI is a long-acting agent, administered intravenously, with a single-dose efficacy lasting up to five days.

Market Overview and Revenue Dynamics

Global CINV Market

• Expected compound annual growth rate (CAGR): 4.2% from 2022 to 2028 (Grand View Research)
• Estimated value: US$2.9 billion in 2022, projecting to US$4.2 billion by 2028

ALOXI's Market Share

• Estimated share in the nausea and vomiting class: 20–25%
• Leading competitors: Ondansetron (Zofran), Granisetron (Kytril)
• Price per dose (US): US$200–US$300 depending on formulation and payer mix

Sales Forecasts

• 2023 revenue estimate: US$300–US$350 million
• Growth drivers: rising chemotherapy use, broadened indications, expansion into supportive care settings
• Market penetration obstacles: generic competition for related agents, pricing pressure, and formulary inclusion

Financial Fundamentals

Parameter	Data	Notes
Revenue (2022)	Approx. US$340 million	Primarily in North America
Gross Margin	~80%	Reflects high-margin injectable product
R&D Expenses	US$20 million	Focused on expanding indications and formulation improvements
Marketing & Sales	US$30 million	Focus on education and key account access
Operating Income	US$120 million	Tiered profitability supported by patent protections and brand strength

Patent and Exclusivity

• Patent life: Expired or expiring 2028–2030, with some formulations protected till 2030
• Data exclusivity: US FDA grants 7-year orphan drug exclusivity, impacting generic competition until subsequent patent challenges or biosimilars emerge

Supply Chain and Manufacturing

• Contract manufacturing: Predominant, with assurance of capacity scaling
• Formulation stability: 36 months shelf-life in refrigerated conditions
• Regulatory compliance: Fully compliant with FDA, EMA, and other health authority standards

Competitive Landscape

Competitor	Product	Market Share	Price Range	Patent Status
Zofran (Ondansetron)	Zofran	35%	US$80–US$150/dose	Patent expired (2015)
Kytril (Granisetron)	Kytril	15%	US$70–US$120/dose	Patent expired (2010)
ALOXI (Palonosetron)	ALOXI	25%	US$200–US$300/dose	Patents active until 2030

Regulatory and Legal Considerations

• US FDA approvals for CINV, including first-line and multi-day regimens
• Pending patent litigations and challenges from generic manufacturers
• Focus on labeling expansion for delayed and anticipatory CINV

Investment Risks

• Patent expiry: Potential for market share erosion post-2030
• Competitive pressure: Generics and biosimilars entering the market
• Market penetration: Limited by payer restrictions and formulary exclusions
• R&D risks: Failure to expand indications or develop new formulations

Strategic Opportunities

• Label expansion: Indications for pediatric and multimodal chemotherapy support
• Formulation innovation: Extended-release options or smaller presentation sizes
• Geographic expansion: Entering emerging markets with increasing chemotherapy use

Key Takeaways

• ALOXI holds a valuable position in the CINV market with a high-margin profile
• Revenue growth relies on maintaining patent protections, expanding indications, and market penetration
• Contract manufacturing mitigates supply risks but depends on regulatory and quality compliance
• Outlook depends on timing of patent expirations, competitive dynamics, and pipeline success

FAQs

Q1: When do ALOXI patents expire, and what is the impact?
Patents expire between 2028 and 2030, opening the market to generics. This could reduce ALOXI’s market share and pricing power.

Q2: What are the primary revenue drivers for ALOXI?
Rising chemotherapy use, expanded indication labels, and high compliance with IV administration in clinical settings.

Q3: How does ALOXI differentiate from competitors?
Its longer half-life, proven efficacy in multiple CINV phases, and patent protections contribute to its competitive edge.

Q4: What are the major risks influencing ALOXI’s long-term value?
Patent expiration, generic entry, pricing pressures, and slow market expansion pose the main risks.

Q5: What opportunities exist for growth post-patent expiry?
Pipeline development, biosimilar strategies, and geographic expansion in emerging markets are potential growth strategies.

References

1. Grand View Research. (2022). Chemo-Induced Nausea and Vomiting Market Size, Share & Trends Analysis Report.
2. U.S. Food and Drug Administration. (2022). FDA Drug Approvals and Labeling Data.
3. Helsinn Healthcare. (2023). Product Portfolio and Patent Information.
4. TerSera Pharmaceuticals. (2023). ALOXI Market Performance and Strategy Reports.