PALONOSETRON HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for palonosetron hydrochloride and what is the scope of freedom to operate?

Palonosetron hydrochloride is the generic ingredient in three branded drugs marketed by Helsinn Hlthcare, Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Hikma, and Avyxa Holdings, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for palonosetron hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for PALONOSETRON HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	23
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	133
Patent Applications:	2,168
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PALONOSETRON HYDROCHLORIDE
What excipients (inactive ingredients) are in PALONOSETRON HYDROCHLORIDE?	PALONOSETRON HYDROCHLORIDE excipients list
DailyMed Link:	PALONOSETRON HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PALONOSETRON HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Helsinn Healthcare SA	PHASE2
Qilu Pharmaceutical Co., Ltd.	PHASE3
Fujian Shengdi Pharmaceutical Co., Ltd.	PHASE3

See all PALONOSETRON HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		0.25MG(BASE)/5ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PALONOSETRON HYDROCHLORIDE

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for PALONOSETRON HYDROCHLORIDE

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for PALONOSETRON HYDROCHLORIDE

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 PALONOSETRON HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avet Lifesciences	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	202951-002	Jun 29, 2021	AP	RX	No	No
Sagent Pharms Inc	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	205870-001	Sep 19, 2018	AP	RX	No	No
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No
Hikma	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	SOLUTION;INTRAVENOUS	207963-001	Aug 22, 2016		DISCN	No	No

Expired US Patents for PALONOSETRON HYDROCHLORIDE

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

Market Dynamics and Financial Trajectory for Palonosetron Hydrochloride

Last updated: July 27, 2025

Introduction

Palonosetron hydrochloride, a potent 5-HT3 receptor antagonist, has emerged as a critical agent in the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). Approved by the FDA in 2003, it has since become a standard component of antiemetic regimens, especially for highly emetogenic chemotherapies. Its unique pharmacological profile and favorable efficacy have positioned it as a lucrative segment within the broader antiemetic drug market. This report analyzes the current market dynamics and forecasts the financial trajectory of palonosetron hydrochloride, considering emerging trends, regulatory influences, competitive landscape, and technological innovations.

Market Overview

Global Market Size and Growth

The global antiemetic drugs market was valued at approximately USD 4.1 billion in 2021 (industry reports), with palonosetron accounting for a significant portion owing to its widespread adoption. Analysts project a compounded annual growth rate (CAGR) of around 6-8% through 2028, driven by rising cancer incidences, expanding late-stage chemotherapy applications, and increasing awareness of CINV management. The segment specific to palonosetron is expected to hold steady, supported by its therapeutic advantages over first-generation agents like ondansetron and granisetron.

Key Markets and Regional Trends

North America dominates the global market, attributable to advanced healthcare infrastructure, high cancer prevalence, and robust R&D investments. Europe follows, with mature healthcare policies and strong clinical adoption. Asia-Pacific presents the highest growth potential, due to increasing cancer rates, expanding oncology centers, and increased healthcare expenditure in emerging economies like China and India. These regional dynamics influence global sales trajectories and investment flows into palonosetron development and marketing.

Market Drivers

Efficacy and Safety Profile

Palonosetron demonstrates superior efficacy in preventing delayed CINV and offers a favorable safety profile, including fewer adverse effects compared to older agents. Its long half-life (~40 hours) ensures sustained receptor blockade, reducing hospital readmissions and improving patient quality of life, thereby cementing its role in standard chemotherapeutic regimens.

Broadened Clinical Indications

Beyond CINV, palonosetron finds application in radiotherapy-related nausea and postoperative nausea and vomiting (PONV), expanding its therapeutic scope. Moreover, ongoing clinical trials exploring additional indications such as irritable bowel syndrome (IBS) may unlock new revenue streams.

Regulatory Approvals and Reimbursements

Regulatory approval processes in key markets are favorable, with additional formulations such as subcutaneous injections and combination therapies receiving authorization. Reimbursement policies, particularly in the U.S. and Europe, bolster healthcare provider adoption.

Market Challenges

Generic Competition

Patent expiry (approximately 2018-2020) has led to an influx of generic palonosetron formulations, exerting downward pressure on prices and margins. Manufacturers must diversify through formulations, combination products, or value-added services to sustain revenue.

Pricing Pressures and Cost-Containment

Healthcare systems globally are under cost-containment pressures, compelling drug pricing negotiations and rebate agreements. These factors impact the profitability of patent-protected products and generic variants alike.

Competitive Landscape

The antiemetic market faces intense competition from other 5-HT3 antagonists and neurokinin-1 receptor antagonists (e.g., aprepitant), which are often used in combined regimens. The dominance of oral formulations also favors convenience, influencing prescribing patterns.

Technological and Innovative Trends

Formulation Advancements

Innovations include the approval of single-dose vials, compact prefilled syringes, and sustained-release formulations that enhance patient compliance and reduce hospital visits.

Combination Therapies

Pharmaceutical companies are developing fixed-dose combinations (FDCs) pairing palonosetron with corticosteroids or neurokinin receptor antagonists to improve efficacy, simplify dosing, and capture larger market share.

Digital Health Integration

Integration of digital health monitoring tools and pharmacovigilance platforms enhances safety profiles and patient adherence, potentially expanding market acceptance.

Financial Trajectory and Investment Outlook

Revenue Projections

Prior to patent expiry, palonosetron generated annual revenues exceeding USD 500 million globally. Post-patent, revenues declined but stabilized due to generic adoption, with estimates ranging between USD 150-200 million annually. Future growth hinges on innovative formulations, new indications, and strategic partnerships.

Market Entry and Expansion Strategies

Biopharma companies are investing in biosimilar development, exploring innovative delivery mechanisms, and expanding into emerging markets. Entry into combination therapies and securing regulatory approvals for new indications are critical growth strategies.

Profitability Considerations

While initial patent protections offered high margins, the shift to generics has compressed profitability. Maintaining revenue streams requires active lifecycle management, including acquiring or developing value-added formulations and leveraging data to support expanded indications.

Regulatory and Policy Impact

Regulatory agencies' evolving frameworks towards biosimilars and generics influence market dynamics significantly. Favorable policies can accelerate access to low-cost alternatives, constraining pricing but expanding patient access. Conversely, tightened patent protections or barriers to innovation can restrict market growth.

Conclusion

The market landscape for palonosetron hydrochloride is characterized by a mature core with significant room for growth through innovation, expanded indications, and strategic regional investments. The transition from patent protection to generic competition necessitates value differentiation strategies, including advanced formulations and combination products. An active pipeline, coupled with technological advancements and favorable regulatory environments, will shape the drug’s financial trajectory over the coming years.

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Key Takeaways

• Steady Demand: The global antiemetic market's growth, driven by increasing cancer prevalence and broader therapeutic indications, sustains demand for palonosetron amidst intense competition.

• Patent Expiry Impact: Patent expiration has introduced generics, reducing prices but expanding access and overall sales volume. Companies must innovate to maintain margins.

• Innovation as a Differentiator: Developing combination therapies, novel delivery systems, and expanding indications are essential for revenue sustainability.

• Regional Opportunities: Asia-Pacific presents an expansive growth opportunity due to rising healthcare investments and expanding oncology services.

• Regulatory Dynamics: Favorable policies for biosimilars and generics in major markets can influence pricing, reimbursement, and market share strategies.

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FAQs

Q1: What are the main competitors to palonosetron in the antiemetic market?
A1: The primary competitors include other 5-HT3 receptor antagonists such as ondansetron, granisetron, and dolasetron, as well as neurokinin-1 receptor antagonists like aprepitant and fosaprepitant. These are often used in combination for enhanced efficacy.

Q2: How does patent expiration affect palonosetron's market performance?
A2: Patent expiry typically leads to the entry of generics, which reduces drug prices and profit margins. However, increased market penetration due to lower prices can offset volume declines, maintaining overall revenue levels.

Q3: What are the emerging therapeutic areas for palonosetron?
A3: Beyond CINV, palonosetron is being explored in radiotherapy-associated nausea, postoperative nausea and vomiting (PONV), and potentially other gastrointestinal disorders like irritable bowel syndrome.

Q4: How are pharmaceutical companies innovating to sustain palonosetron sales?
A4: Companies are developing combination therapies, new formulations with sustained-release properties, and expanding into emerging markets. Digital health integration and pharmacovigilance also support product value.

Q5: What role does regional market growth play in the overall financial outlook?
A5: Rapidly developing regions such as Asia-Pacific offer significant growth opportunities due to increasing cancer patient populations, healthcare infrastructure development, and improved access, which can balance revenue declines in mature markets.

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Sources

1. Industry reports on antiemetic drugs market (2022).
2. U.S. Food and Drug Administration (FDA) approvals database.
3. Market research analyses from GlobalData and IBISWorld.
4. Clinical trial data repositories (clinicaltrials.gov).
5. Pharmaceutical patent expiry timelines and biosimilar policies (European Medicines Agency, EMA).