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Last Updated: August 12, 2020

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ALOXI Drug 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.

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. Eighteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Paragraph IV (Patent) Challenges for ALOXI
Tradename Dosage Ingredient NDA Submissiondate
ALOXI INJECTABLE;INTRAVENOUS palonosetron hydrochloride 021372 2011-05-27

US Patents and Regulatory Information for 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   Start Trial   Start Trial   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 CAPSULE;ORAL 022233-001 Aug 22, 2008   Start Trial   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008   Start Trial   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ALOXI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0430190 C00430190/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0430190 CA 2005 00023 Denmark   Start Trial
2785706 LUC00158 Luxembourg   Start Trial PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190 SPC/GB05/032 United Kingdom   Start Trial 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 300194 Netherlands   Start Trial 300194, 20101127, EXPIRES: 20151126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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