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Last Updated: August 10, 2022

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 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid pharmaceutical formulations of palonosetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid pharmaceutical formulations of palonosetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid pharmaceutical formulations of palonosetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid pharmaceutical formulations of palonosetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid pharmaceutical formulations of palonosetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid pharmaceutical formulations of palonosetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 See Plans and Pricing See Plans and Pricing
>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
Luxembourg 91162 See Plans and Pricing
Australia 642178 See Plans and Pricing
Brazil 1100680 See Plans and Pricing
South Korea 20050104363 LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON See Plans and Pricing
Hungary 907660 See Plans and Pricing
European Patent Office 2008659 Formules pharmaceutiques liquides de palonos├ętron (Liquid pharmaceutical formulations of palonosetron) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALOXI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0430190 91162 Luxembourg See Plans and Pricing 91162, EXPIRES: 20151127
0430190 SPC/GB05/032 United Kingdom See Plans and Pricing 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 C00430190/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
0430190 CA 2005 00023 Denmark See Plans and Pricing
2785706 2020C/516 Belgium See Plans and Pricing PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706 122020000046 Germany See Plans and Pricing PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
McKesson
Boehringer Ingelheim
Colorcon
Johnson and Johnson

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.