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Last Updated: March 29, 2024

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. Twenty-four 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 Sumitomo Pharma America, 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 Sumitomo Pharma America, 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 28, 2010TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 26, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Nov 26, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Aug 20, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 200603

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