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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Daiichi Sankyo
US Army

Generated: July 20, 2017

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 two suppliers. There are seven 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-four 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 NDA: 200603

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
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)
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)

Summary 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:
Patent:5,532,372*PEDPatent Expiration:Jan 2, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:8,729,085*PEDPatent Expiration:Nov 26, 2026Product Flag?Substance Flag?Delist Request?Y

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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
US Department of Justice
Harvard Business School
Fish and Richardson
Cantor Fitzgerald
Queensland Health

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