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Serving leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
Farmers Insurance
McKinsey
Argus Health
Cerilliant
Mallinckrodt
Cantor Fitzgerald
AstraZeneca
Express Scripts

Generated: October 18, 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. One supplier is listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Summary for NDA: 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 Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-001Jul 25, 2003► Subscribe► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-002Feb 29, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Department of Justice
Covington
Healthtrust
Fish and Richardson
Colorcon
Novartis
Chubb
Johnson and Johnson
Moodys
Accenture

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 verifification 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.

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