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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 five 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:
LIVALO
Applicant:
Kowa Co
Ingredient:
pitavastatin calcium
Patents:5
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:RLD:No
Patent:5,854,259Patent Expiration:Dec 29, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,465,477Patent Expiration:Dec 20, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:8,557,993Patent Expiration:Feb 2, 2024Product Flag?YSubstance Flag?Delist Request?

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;ORAL022363-003Aug 3, 20095,854,259► subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 20095,753,675► subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 20095,753,675► subscribe
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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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