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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 021372


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NDA 021372 describes ALOXI, which is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ALOXI profile page.

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.
Summary for 021372
Tradename:ALOXI
Applicant:Helsinn Hlthcare
Ingredient:palonosetron hydrochloride
Patents:13
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372 NDA AUTHORIZED GENERIC Cipla USA Inc. 69097-927 69097-927-35 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 25, 2003TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021372

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 021372-002 Feb 29, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.