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Last Updated: March 28, 2024

ALOXI Drug Patent Profile


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Which patents cover Aloxi, 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. Nineteen 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 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
>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
New Zealand 541533 Liquid pharmaceutical formulations of palonosetron ⤷  Try a Trial
South Korea 970007917 ⤷  Try a Trial
Iceland 7984 Palonsetron lyfjasamsetningar á vökvaformi ⤷  Try a Trial
Israel 96486 Tricyclic compounds, their preparation and pharmaceutical compositions containing them ⤷  Try a Trial
Norway 329500 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALOXI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0430190 C00430190/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0430190 300194 Netherlands ⤷  Try a Trial 300194, 20101127, EXPIRES: 20151126
0430190 91162 Luxembourg ⤷  Try a Trial 91162, EXPIRES: 20151127
0430190 18/2005 Austria ⤷  Try a Trial PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
2785706 LUC00158 Luxembourg ⤷  Try a Trial PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.