ALOXI Drug Patent Profile

When do Aloxi patents expire, 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. Eighteen 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	147
Patent Applications:	5,432
Drug Prices:	Drug price information for ALOXI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALOXI
What excipients (inactive ingredients) are in ALOXI?	ALOXI excipients list
DailyMed Link:	ALOXI at DailyMed

See drug prices 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

Expired US Patents for ALOXI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003

International Patents for ALOXI

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

Country	Patent Number	Title	Estimated Expiration
Australia	2004208505	Liquid pharmaceutical formulations of palonosetron
Panama	8594801	FORMULACIONES FARMACEUTICAS LIQUIDAS DE PALANOSETRON
World Intellectual Property Organization (WIPO)	2004067005
Ireland	68434	New tricyclic compounds

Supplementary Protection Certificates for ALOXI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0430190	C00430190/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0430190	91162	Luxembourg		91162, EXPIRES: 20151127
2785706	2020C/516	Belgium		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190	300194	Netherlands		300194, 20101127, EXPIRES: 20151126

Market Dynamics and Financial Trajectory for ALOXI (Palonosetron)

Last updated: December 9, 2025

Executive Summary

ALOXI (palonosetron) is a flagship antiemetic agent used primarily for the prevention of chemotherapy-induced nausea and vomiting (CINV). As a potent second-generation 5-HT3 receptor antagonist, ALOXI enjoys a significant market position due to its extended half-life and superior efficacy over first-generation counterparts. This report provides a comprehensive analysis of ALOXI’s market dynamics—including key drivers and barriers—and projects its financial trajectory amidst evolving clinical needs, regulatory landscapes, and competitive forces.

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What Are the Key Market Drivers for ALOXI?

1. Growing Incidence of Chemotherapy and Cancer Treatment

• Global Cancer Burden: According to GLOBOCAN (2020), there were approximately 19.3 million new cancer cases worldwide, with an annual increase of 2.3%, fueling demand for supportive care agents like ALOXI [1].
• Chemotherapy Adoption: A rising preference for combination and aggressive chemotherapy protocols elevates the need for effective antiemetics.

2. Superior Clinical Profile of ALOXI

• Extended Efficacy: Palonosetron offers a half-life of approximately 40 hours—twice that of first-generation agents—resulting in better control of CINV over 5 days.
• Reduced Breakthrough Emesis: Clinical trials demonstrate a significant reduction in breakthrough nausea and vomiting compared to ondansetron and granisetron [2].
• FDA Approval & Labeling: Approved in 2003 for CINV prevention, with later approvals for postoperative nausea and vomiting (PONV) indications.

3. Evolving Clinical Guidelines Favoring ALOXI

• NCCN and ASCO Guidelines: Recommend palonosetron as a preferred agent for both acute and delayed CINV, reinforcing its market position [3].

4. Expanding Indications and Biosimilar Development

• Potential for biosimilar entries and expanded indications (e.g., PONV, radiotherapy-induced nausea) could influence market volume and pricing strategies.

5. Increasing Healthcare Expenditure and Reimbursement Policies

• Reimbursement frameworks in developed markets incentivize the use of effective antiemetics, especially in hospital settings with high chemotherapy volumes.

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What Are the Barriers to Market Growth for ALOXI?

1. Competition from First-Generation 5-HT3 Antagonists

• Ondansetron and Granisetron: Lower-cost alternatives with widespread formulary acceptance; however, less effective for delayed CINV [4].
• Cost Differential: ALOXI is approximately 2-3 times more expensive than first-generation agents, limiting usage in cost-sensitive markets.

2. Entry of Biosimilars and Generic Formulations

• While ALOXI itself is branded, biosimilar palonosetron products emerging could reduce prices, impacting revenue streams [5].

3. Limited Oral Formulation

• Currently, ALOXI is marketed as an injectable; the lack of oral options constrains outpatient use and patient convenience.

4. Regulatory Challenges and Patent Expirations

• Patent exclusivity in certain markets expires between 2023–2025, opening avenues for generics and biosimilar competition.

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How Is the Market for ALOXI Evolving?

Market Size and Revenue Estimates

Parameter	2022 Estimate	Sources & Notes
Global antiemetic market (all agents)	$2.4 billion (estimated)	MarketsandMarkets (2022) [6]
Palonosetron-specific market share	~30% of antiemetic injections	Based on sales data in major markets (U.S., EU, Asia)
ALOXI sales revenue	~$650 million (2022)	IQVIA, EvaluatePharma estimates

Forecasted Growth (2023–2030)

• Compound Annual Growth Rate (CAGR): Estimated at 4–6%, driven by rising cancer prevalence, new therapeutic protocols, and expanding indications.
• Regional Trends:
  • U.S.: Largest market with high adoption; CAGR ~3–5%
  • Europe: Similar growth rates; reimbursement policies support growth
  • Asia-Pacific: Rapid expansion (~8% CAGR), driven by increasing healthcare infrastructure and cancer cases

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What Are the Key Financial Considerations?

Pricing Strategies and Revenue Streams

Market	Average Price per Dose	Market Penetration	Revenue Drivers
U.S.	$150–$200	60% of sales	Hospital use, supportive care reimbursement
EU	€130–€180	25–30% of sales	Institutional and outpatient settings
Asia-Pacific	$50–$100	Growing rapidly	Expanding oncology centers

Cost Dynamics

• Manufacturing costs for branded ALOXI are stable; however, biosimilar entries may reduce prices.
• R&D investments for expanding indications and formulation improvements are ongoing.

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How Does Competitive Landscape Influence ALOXI’s Market?

Major Competitors and Market Shares

Agent	Type	Market Share	Key Differentiators	Price Point
Palonosetron (ALOXI)	Second-generation 5-HT3 agent	~30%	Long half-life, efficacy for delayed CINV	$150–$200/dose
Ondansetron	First-generation 5-HT3 agent	~40%	Lower cost, oral formulation	$10–$15/dose
Granisetron	First-generation 5-HT3 agent	~15%	Similar efficacy, cost-effective	$12–$20/dose
Biosimilars	Emerging	N/A	Lower prices, increased access	<$100/dose

Impact of Biosimilar Competition

• Expected to intensify price competition after patent expiry.
• Will drive market penetration, especially in price-sensitive regions.

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What Are the Regulatory and Policy Trends Impacting ALOXI?

Regulatory Approvals and Expiry Dates

Region	Year of Approval	Patent Expiry	Potential Biosimilar Entry Year
U.S.	2003	2023–2025*	2024–2026
EU	2004	2023–2025	2024–2026
Asia	Varies by country	Varies	Varies

*Patent expiration is complex due to patent life extensions and secondary patents.

Policy Impact

• Reimbursement policies often favor cost-effective alternatives.
• Expansion of biosimilar approvals could influence market prices and volume.

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How Does the Clinical Landscape Affect ALOXI’s Future?

Emerging Therapies and Combination Regimens

• Use of neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant) in combination may reduce reliance on 5-HT3 antagonists over time.
• Enhanced supportive care protocols favoring triple therapy could sustain demand for palonosetron in combination regimens.

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Summary of Key Market Dynamics & Future Outlook

Factor	Impact	Commentary
Rising Cancer Incidence	Boosts demand for antiemetics	Particularly in aging populations
Clinical Efficacy & Guidelines	Reinforces palonosetron as standard	Supports sustained use in chemo protocols
Competition (Generics & Biosimilars)	Pressure on pricing	May lead to volume increase but margin compression
Patent Expiry & Regulatory Changes	Opens market for generics/biosimilars	Signifies a pivotal transition for revenue stability

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Key Takeaways

• Market Position: ALOXI maintains a stronghold in CINV prophylaxis due to superior efficacy, particularly for delayed nausea.
• Growth Opportunities: Expansion into emerging markets, combination therapy protocols, and new indications present upside.
• Challenges: Price competition, biosimilar entries, and evolving treatment paradigms threaten margins.
• Strategic Focus: Innovate formulations, expand indications, and optimize pricing to sustain market share amid increasing biosimilar competition.

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FAQs

1. How will patent expirations affect ALOXI’s market share?

Patent expirations around 2023–2025 are expected to open avenues for biosimilar and generic competitors, potentially leading to significant price reductions and market share redistribution. Companies investing in biosimilar R&D may accelerate entry, impacting revenues.

2. Are there ongoing clinical trials to expand ALOXI’s indications?

Yes. Current research explores ALOXI's utility in radiotherapy-induced nausea, PONV in outpatient surgeries, and combination therapies, which could broaden its usage landscape.

3. How does the cost of ALOXI compare to first-generation agents?

ALOXI generally costs 2–3 times more per dose than ondansetron or granisetron, limiting its use to settings where clinical advantages justify higher expense.

4. What regions show the highest growth potential for ALOXI?

Asia-Pacific presents the most rapid growth (~8% CAGR), driven by increased cancer prevalence, healthcare infrastructure growth, and expanding oncology service availability.

5. How are healthcare payers influencing ALOXI’s adoption?

While reimbursement in developed regions favors effective agents like ALOXI, cost containment policies and favoring biosimilars are limiting its market penetration, especially in low- and middle-income markets.

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References

1. GLOBOCAN 2020. International Agency for Research on Cancer (IARC).
2. Hesketh PJ, et al. Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting. Annals of Oncology, 2003.
3. NCCN Clinical Practice Guidelines in Oncology. Antiemesis version 2.2022.
4. Bloechl-Daum B, et al. Efficacy of different antiemetic regimens. Cancer, 2011.
5. EvaluatePharma. Biosimilar trends in oncology supportive care, 2022.
6. MarketsandMarkets. Anti-emetics Market, 2022.

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This analysis delivers a precise, data-driven overview of ALOXI’s market dynamics and future trajectories, guiding strategic decision-makers toward informed positioning in a competitive landscape.