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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

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 four suppliers. 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
Pharmacology for NDA: 021372
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 Accord Healthcare, Inc. 16729-365 16729-365-66 1 VIAL in 1 CARTON (16729-365-66) > 5 mL in 1 VIAL
ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372 NDA Eisai Inc. 62856-797 62856-797-01 1 VIAL in 1 CARTON (62856-797-01) > 5 mL in 1 VIAL
Paragraph IV (Patent) Challenges for 021372
Tradename Dosage Ingredient NDA Submissiondate
ALOXI INJECTABLE;INTRAVENOUS palonosetron hydrochloride 021372 2011-05-27

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:Jul 25, 2003TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
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