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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
AstraZeneca
Johnson and Johnson
Deloitte
Baxter
Accenture
Citi
Healthtrust

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200603

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NDA 200603 describes LATUDA, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LATUDA profile page.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 200603
Tradename:LATUDA
Applicant:Sunovion Pharms Inc
Ingredient:lurasidone hydrochloride
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 200603
Suppliers and Packaging for NDA: 200603
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATUDA lurasidone hydrochloride TABLET;ORAL 200603 NDA Sunovion Pharmaceuticals Inc. 63402-302 N 63402-302-04
LATUDA lurasidone hydrochloride TABLET;ORAL 200603 NDA Sunovion Pharmaceuticals Inc. 63402-302 N 63402-302-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 28, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Mar 5, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jul 27, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cipla
Cerilliant
Johnson and Johnson
Citi
US Department of Justice
Moodys
Chinese Patent Office
Teva

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