ALOXI Drug Patent Profile

Which patents cover Aloxi, and what generic alternatives are available?

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.

Patents protecting 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	021372-001	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	021372-002	Feb 29, 2008		DISCN	Yes	No					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
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	CAPSULE;ORAL	022233-001	Aug 22, 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
Japan	2006516583
South Korea	101113084
Georgia, Republic of	P20084445	LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
Ukraine	90449	ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА;РІДКІ ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ ПАЛОНОСЕТРОНУ (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)

Supplementary Protection Certificates for ALOXI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	C02785706/01	Switzerland		PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
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	2020C/516	Belgium		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190	C00430190/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH