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Generated: January 23, 2019

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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 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Aug 3, 2009TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 25, 2020Product Flag?Substance Flag?YDelist Request?
Patented Use:ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPROTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
Patent:➤ Try a Free TrialPatent Expiration:Feb 19, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPROTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
Patent:➤ Try a Free TrialPatent 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 ➤ Try a Free Trial ➤ Try a Free Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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