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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Daiichi Sankyo
Dow
Queensland Health
Chinese Patent Office
Cantor Fitzgerald
McKinsey
Medtronic

Generated: July 19, 2018

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 three 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 fifteen 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 022363
Tradename:LIVALO
Applicant:Kowa Co
Ingredient:pitavastatin calcium
Patents:3
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 N 66869-104-90
LIVALO pitavastatin calcium TABLET;ORAL 022363 NDA Kowa Pharmaceuticals America, Inc. 66869-204 N 66869-204-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Aug 3, 2009TE:ABRLD:Yes
Patent:➤ Sign UpPatent 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:➤ Sign UpPatent 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
Patent:➤ Sign UpPatent Expiration:Feb 2, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022363

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Harvard Business School
AstraZeneca
Teva
Queensland Health
Deloitte
Cipla
Baxter
Julphar

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