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Serving leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Harvard Business School
Medtronic
Boehringer Ingelheim
Healthtrust
QuintilesIMS
Citi
McKinsey
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Generated: February 19, 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 nine 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:9
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 63402-302-30
LATUDA lurasidone hydrochloride TABLET;ORAL 200603 NDA Sunovion Pharmaceuticals Inc. 63402-302 N 63402-302-50

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:Jul 27, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17

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Cantor Fitzgerald
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Julphar
Federal Trade Commission
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Dow

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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