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. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Palonosetron hydrochloride has fifty-three patent family members in forty countries.

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

Summary for PALONOSETRON HYDROCHLORIDE

International Patents:	53
US Patents:	13
Tradenames:	3
Applicants:	19
NDAs:	23
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	124
Patent Applications:	1,249
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
SanQing Jin	N/A
Sichuan Cancer Hospital and Research Institute	N/A
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4

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
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No					Y
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No					Y
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No					Y
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No					Y
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No					Y
Sagent Pharms Inc	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	205870-001	Sep 19, 2018	AP	RX	No	No
Baxter Hlthcare Corp	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	206916-001	Nov 12, 2021	AP	RX	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
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

International Patents for PALONOSETRON HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2573241	FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)
Canada	2573228	FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)
Australia	2004208505	Liquid pharmaceutical formulations of palonosetron
Germany	602004016967
Canada	2573194	FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)
South Korea	20050104363	LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
European Patent Office	1601359	FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRON (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)

Supplementary Protection Certificates for PALONOSETRON HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	LUC00158	Luxembourg		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706	2020C/516	Belgium		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190	SPC/GB05/032	United Kingdom		PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
2785706	C02785706/01	Switzerland		PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
1035115	92745	Luxembourg		PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
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

PALONOSETRON HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Palonosetron Hydrochloride

Introduction

Palonosetron hydrochloride, a 5-HT3 receptor antagonist, is a crucial medication in the management of chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV). Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, growth prospects, and key market players.

Market Size and Growth

As of 2023, the global market size for palonosetron hydrochloride is estimated to be approximately USD 800 million. This market is forecasted to grow significantly, reaching USD 1.4 billion by 2032[1].

Growth Drivers

Several factors are driving the growth of the palonosetron hydrochloride market:

Increasing Incidence of Cancer

The rising incidence of cancer globally has led to an increased demand for effective antiemetic treatments. Palonosetron hydrochloride, with its efficacy in preventing both acute and delayed CINV, is a preferred choice among oncologists[2].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing countries, have enhanced access to advanced medications like palonosetron hydrochloride. This expansion is expected to continue, driving market growth[4].

Generic Market Entry

The launch of generic versions of palonosetron hydrochloride, such as Avenacy's Palonosetron Hydrochloride Injection, USP, has increased market competition and affordability. This has contributed to the market's growth trajectory[2].

Market Segmentation

The palonosetron hydrochloride market can be segmented based on several factors:

Route of Administration

The drug is available in intravenous (IV) formulations, which are the primary mode of administration. The market is also seeing interest in other routes, but IV remains dominant[4].

Indications

Palonosetron hydrochloride is indicated for the prevention of:

• Acute and delayed CINV associated with moderately and highly emetogenic chemotherapy.
• Acute nausea and vomiting associated with postoperative care[2].

Geographic Regions

The market is segmented geographically, with North America and Europe being significant contributors due to high healthcare spending and advanced medical infrastructure. However, emerging markets in Asia-Pacific are also showing promising growth[1].

Key Market Players

Several companies are key players in the palonosetron hydrochloride market:

Eisai Inc.

Eisai Inc. is the original developer and marketer of Aloxi, the branded version of palonosetron hydrochloride. Despite the entry of generics, Eisai remains a significant player due to its established brand and market presence[3].

Avenacy

Avenacy, a specialty pharmaceutical company, has recently launched a generic version of palonosetron hydrochloride injection in the U.S. market. This launch is expected to increase competition and expand market reach[2].

Financial Performance

The financial performance of palonosetron hydrochloride is robust and growing:

Revenue

In the twelve months ending in June 2023, palonosetron hydrochloride injection had U.S. sales of approximately $20 million. The global market is projected to reach USD 1.4 billion by 2032, indicating a substantial growth potential[1][2].

CAGR

The global palonosetron hydrochloride market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of around 5.2% during the forecast period from 2020 to 2027[4].

Competitive Landscape

The competitive landscape of the palonosetron hydrochloride market is characterized by:

Generic Competition

The entry of generic versions has increased competition, driving prices down and making the drug more accessible to a wider patient population[2].

Differentiated Packaging

Companies like Avenacy are focusing on differentiated packaging and labeling to enhance patient safety and streamline patient care, which can be a competitive advantage[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of palonosetron hydrochloride:

FDA Approvals

Palonosetron hydrochloride has received FDA approval for various indications, including CINV and PONV. Generic versions must also meet FDA standards, ensuring high-quality products in the market[2].

cGMP Compliance

Manufacturing partners of companies like Avenacy must comply with Current Good Manufacturing Practices (cGMP) standards, which are critical for maintaining product quality and regulatory compliance[2].

Patient and Clinician Input

Patient and clinician input are vital for the reimbursement and approval processes of palonosetron hydrochloride:

Reimbursement Reviews

In Canada, for example, patient and clinician input were sought during the reimbursement review process for palonosetron hydrochloride, highlighting its importance in real-world clinical settings[3].

Clinical Trials and Research

Ongoing clinical trials and research are essential for the continued development and optimization of palonosetron hydrochloride:

Phase 2 and 3 Trials

Several Phase 2 and 3 trials are underway, exploring the efficacy of palonosetron hydrochloride in combination with other antiemetics and in different patient populations[5].

Conclusion

The market for palonosetron hydrochloride is poised for significant growth driven by increasing cancer incidence, advancements in healthcare infrastructure, and the entry of generic versions. Key players like Eisai and Avenacy are shaping the market through innovative products and differentiated packaging. As the global healthcare landscape continues to evolve, palonosetron hydrochloride is expected to remain a critical component in the management of CINV and PONV.

Key Takeaways

• Market Size and Growth: The global market size for palonosetron hydrochloride is estimated at USD 800 million in 2023, projected to reach USD 1.4 billion by 2032.
• Growth Drivers: Increasing cancer incidence, healthcare infrastructure improvements, and generic market entry are key growth drivers.
• Market Segmentation: The market is segmented by route of administration, indications, and geographic regions.
• Key Players: Eisai Inc. and Avenacy are significant players in the market.
• Financial Performance: The market is growing at a CAGR of around 5.2%, with substantial revenue projections.
• Competitive Landscape: Generic competition and differentiated packaging are key competitive factors.
• Regulatory Environment: FDA approvals and cGMP compliance are crucial for market participation.

FAQs

Q: What is the primary indication for palonosetron hydrochloride? A: The primary indication for palonosetron hydrochloride is the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV)[2].

Q: Who are the key players in the palonosetron hydrochloride market? A: Key players include Eisai Inc., the original developer of Aloxi, and Avenacy, which has launched a generic version of palonosetron hydrochloride injection[2][3].

Q: What is the projected market size for palonosetron hydrochloride by 2032? A: The global market size for palonosetron hydrochloride is projected to reach USD 1.4 billion by 2032[1].

Q: What is the CAGR of the global palonosetron hydrochloride market? A: The global palonosetron hydrochloride market is anticipated to grow at a CAGR of around 5.2% during the forecast period from 2020 to 2027[4].

Q: What are the significant growth drivers for the palonosetron hydrochloride market? A: Significant growth drivers include the increasing incidence of cancer, advancements in healthcare infrastructure, and the entry of generic versions of the drug[1][2][4].

Sources

1. DataIntelo, Global Palonosetron Hydrochloride Market Research Report 2032.
2. BusinessWire, Avenacy Announces Launch of Palonosetron Hydrochloride Injection, USP in the U.S. Market.
3. CDA-AMC, Palonosetron hydrochloride.
4. Acumen Research and Consulting, Palonosetron Hydrochloride Market (By Route Of Administration).
5. Synapse, Palonosetron hydrochloride - Drug Targets, Indications, Patents.