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Last Updated: November 4, 2024

ALOXI Drug Patent Profile


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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.

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Drug patent expirations by year for ALOXI
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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

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Liquid pharmaceutical formulations of palonosetron
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Liquid pharmaceutical formulations of palonosetron
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Liquid pharmaceutical formulations of palonosetron
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Patent Expiration: ⤷  Sign Up

Liquid pharmaceutical formulations of palonosetron
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Patent Expiration: ⤷  Sign Up

Liquid pharmaceutical formulations of palonosetron
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Patent Expiration: ⤷  Sign Up

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ALOXI

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

International Patents for ALOXI

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

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 014066 ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON) ⤷  Sign Up
Canada 2514224 FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON) ⤷  Sign Up
Israel 169859 פורמולציות רוקחיות נוזליות של פאלונוסטרון (Liquid pharmaceutical formulations of palonosetron) ⤷  Sign Up
African Regional IP Organization (ARIPO) 2110 Liquid pharmaceutical formulations of palonosetron ⤷  Sign Up
Ireland 904269 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALOXI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1035115 92745 Luxembourg ⤷  Sign Up PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
0430190 CA 2005 00023 Denmark ⤷  Sign Up
2785706 C02785706/01 Switzerland ⤷  Sign Up PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
0430190 18/2005 Austria ⤷  Sign Up PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
0430190 SPC/GB05/032 United Kingdom ⤷  Sign Up PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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