Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 14, 2019

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 three 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. Seventeen 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 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:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:Jul 25, 2003TE:APRLD:Yes
Patent:  See PricingPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:  See PricingPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:  See PricingPatent 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   See Pricing   See Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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