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Last Updated: July 3, 2020

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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 two suppliers. 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. Two suppliers are 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 63402-302-04 4 BLISTER PACK in 1 CARTON (63402-302-04) > 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-07)
LATUDA lurasidone hydrochloride TABLET;ORAL 200603 NDA Sunovion Pharmaceuticals Inc. 63402-302 63402-302-10 10 BLISTER PACK in 1 CARTON (63402-302-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-01)
Paragraph IV (Patent) Challenges for 200603
Tradename Dosage Ingredient NDA Submissiondate
LATUDA TABLET;ORAL lurasidone hydrochloride 200603 2014-10-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 28, 2010TE:ABRLD: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

Expired US Patents for NDA 200603

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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