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Generated: December 16, 2017

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 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. Two suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Summary for 021372

Tradename:1
Applicant:1
Ingredient:1
Patents:13
Therapeutic Class:Antiemetics
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 Eisai Inc. 62856-797 62856-797-01 1 VIAL in 1 CARTON (62856-797-01) > 5 mL in 1 VIAL
ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372 NDA Eisai Inc. 62856-798 62856-798-01 5 VIAL in 1 CARTON (62856-798-01) > 1.5 mL in 1 VIAL

Summary 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
Regulatory Exclusivity Expiration:May 27, 2017
Regulatory Exclusivity Use:ADDITIONAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING REGARDING POST-OPERATIVE NAUSEA AND VOMITING STUDIES IN PEDIATRIC PATIENTS
Regulatory Exclusivity Expiration:Nov 27, 2017
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:May 27, 2017
Regulatory Exclusivity Use:PREVENTION OF ACUTE NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF EMETOGENIC CANCER CHEMOTHERAPY, INCLUDING HIGHLY EMETOGENIC CANCER CHEMOTHERAPY IN PEDIATRIC PATIENTS AGED 1 MONTH TO LESS THAN 17 YEARS

Expired Orange Book Patents for NDA: 021372

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn HlthcareALOXIpalonosetron hydrochlorideINJECTABLE;INTRAVENOUS021372-002Feb 29, 2008► Subscribe► Subscribe
Helsinn HlthcareALOXIpalonosetron hydrochlorideINJECTABLE;INTRAVENOUS021372-001Jul 25, 2003► Subscribe► Subscribe
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