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Serving leading biopharmaceutical companies globally:

Moodys
QuintilesIMS
Healthtrust
Novartis
Chinese Patent Office
Covington
US Department of Justice
Boehringer Ingelheim
Medtronic
Daiichi Sankyo

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022363

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NDA 022363 describes LIVALO, which is a drug marketed by Kowa Co and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LIVALO profile page.

The generic ingredient in LIVALO is pitavastatin calcium. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pitavastatin calcium profile page.

Summary for NDA: 022363

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 022363

Suppliers and Packaging for NDA: 022363

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIVALO
pitavastatin calcium
TABLET;ORAL 022363 NDA Kowa Pharmaceuticals America, Inc. 66869-104 66869-104-90 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-104-90)
LIVALO
pitavastatin calcium
TABLET;ORAL 022363 NDA Kowa Pharmaceuticals America, Inc. 66869-204 66869-204-07 7 TABLET, FILM COATED in 1 CARTON (66869-204-07)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Aug 3, 2009TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Dec 25, 2020Product Flag?Substance Flag?YDelist Request?
Patented Use:ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
Patent:► SubscribePatent Expiration:Dec 20, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Feb 19, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA

Expired Orange Book Patents for NDA: 022363

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Julphar
US Department of Justice
Fish and Richardson
Boehringer Ingelheim
Cipla
Citi
Accenture
Harvard Business School
Moodys
Novartis

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