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. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in forty countries.

The generic ingredient in ALOXI is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one 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

International Patents:	53
US Patents:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Patent Applications:	3,953
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

ALOXI is protected by seven US patents.

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	021372-001	Jul 25, 2003		DISCN	Yes	No	9,125,905*PED				Y
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No	9,173,942*PED				Y
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No	7,960,424*PED				Y

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	9,125,905*PED
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	7,960,424*PED
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008	9,173,942*PED
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	8,518,981*PED

International Patents for ALOXI

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

Country	Patent Number	Title	Estimated Expiration
Spain	2075121
Tunisia	SN05180	LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
Mexico	PA05008028	FORMULACIONES FARMACEUTICAS LIQUIDAS DE PALONOSETRON. (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON.)
Eurasian Patent Organization	200501203	ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА

Supplementary Protection Certificates for ALOXI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0430190	18/2005	Austria		PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
0430190	CA 2005 00023	Denmark
1035115	92745	Luxembourg		PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527

ALOXI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALOXI

Introduction

ALOXI, known generically as palonosetron hydrochloride, is a significant player in the Chemotherapy-Induced Nausea and Vomiting (CINV) drugs market. Here, we delve into the market dynamics and financial trajectory of ALOXI, highlighting its position, growth prospects, and key factors influencing its market performance.

Market Size and Growth

The global CINV existing and pipeline drugs market, within which ALOXI operates, was valued at USD 1.62 billion in 2023 and is expected to grow at a CAGR of 4.9% from 2024 to 2030, reaching nearly USD 2.27 billion by 2030[1][4].

Segmentation and Market Share

ALOXI is categorized under the second-generation serotonin receptor blockers, a segment that is expected to hold a lucrative share of the global CINV market. The drug is particularly noted for its efficacy in preventing acute and delayed nausea and vomiting associated with chemotherapy[1][5].

Regional Performance

North America holds the largest share of the global CINV market, and ALOXI, being approved and widely used in this region, benefits significantly from this dominance. Europe is the second-largest market, although the launch of CINV pipeline drugs, including ALOXI, may be delayed compared to North America[1].

End-Use Segmentation

The market is segmented by end-use into hospitals, specialty clinics, diagnostic centers, hospital pharmacies, and drugstores. Hospitals are the fastest-growing segment, driven by a rising patient population, which positively impacts the demand for ALOXI[1].

Competitive Landscape

ALOXI competes with other prominent CINV drugs such as Emend (aprepitant), Zofran Generic (ondansetron), Kytril Generic (granisetron), SUSTOL (extended release granisetron injection), and Rolapitant. Key players in the market include Helsinn, Heron Therapeutics, Merck, and others. ALOXI's unique selling point is its long-lasting efficacy and minimal side effects, which help it maintain a competitive edge[1][4].

Cost-Utility Analysis

A cost-utility analysis comparing oral palonosetron (ALOXI) with oral ondansetron revealed that while ALOXI is associated with higher costs, it offers minimal incremental quality-adjusted life years (QALYs). The incremental cost per QALY gained with ALOXI is significant, ranging from $9,175 to $39,581 depending on the treatment regimen and duration of use[2].

Clinical Efficacy

ALOXI has demonstrated strong clinical efficacy in preventing nausea and vomiting associated with chemotherapy. It is the first and only 5-HT3 receptor antagonist approved by the FDA for the prevention of acute and delayed nausea and vomiting in both moderately and highly emetogenic chemotherapy. Clinical trials have shown that ALOXI significantly reduces the severity of nausea and vomiting, with a complete response rate of 42.8% in the 0-24 hour period post-treatment[5].

Safety Profile

The safety profile of ALOXI is favorable, with common side effects including ECG QT prolongation, bradycardia, headache, and constipation. However, these side effects are generally mild and comparable to those of placebo in many cases[5].

Financial Performance

The financial performance of ALOXI is closely tied to the overall growth of the CINV market. With the market expected to grow at a CAGR of 4.9%, ALOXI is likely to see increased revenue. The drug's approval for additional indications, such as postoperative nausea and vomiting (PONV), further expands its market potential[1][5].

Key Takeaways

• Market Growth: The CINV market, including ALOXI, is expected to grow at a CAGR of 4.9% from 2024 to 2030.
• Competitive Edge: ALOXI's long-lasting efficacy and minimal side effects make it a preferred choice in the CINV market.
• Regional Dominance: North America is the largest market for ALOXI, with Europe being the second-largest.
• Clinical Efficacy: ALOXI has strong clinical efficacy in preventing nausea and vomiting associated with chemotherapy.
• Cost-Utility: While ALOXI is more expensive, it offers minimal incremental QALYs compared to other treatments.

FAQs

1. What is the expected growth rate of the CINV market, which includes ALOXI?

   • The CINV market is expected to grow at a CAGR of 4.9% from 2024 to 2030[1].

2. Which region holds the largest share of the CINV market for ALOXI?

   • North America holds the largest share of the global CINV market[1].

3. What are the common side effects associated with ALOXI?

   • Common side effects include ECG QT prolongation, bradycardia, headache, and constipation[5].

4. How does ALOXI compare to other CINV drugs in terms of cost-utility?

   • ALOXI is associated with higher costs but offers minimal incremental QALYs compared to other treatments like ondansetron[2].

5. What are the key indications for which ALOXI is approved?

   • ALOXI is approved for the prevention of acute and delayed nausea and vomiting associated with chemotherapy and postoperative nausea and vomiting (PONV)[5].

Sources

1. Maximize Market Research: Global CINV Existing and Pipeline Drugs Market Report.
2. CADTH: Final CDEC Recommendation – Palonosetron Capsule (Aloxi).
3. Heron Therapeutics: Form 10-K for Heron Therapeutics INC DE filed 03/12/2024.
4. Business Research Insights: CINV Existing and Pipeline Drugs Market Size, Forecast | 2032.
5. Eisai Co., Ltd.: FDA APPROVES ALOXI® (PALONOSETRON HCL) INJECTION.