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Fish and Richardson
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Chubb
Medtronic
Queensland Health
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Generated: January 23, 2019

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
Generic Entry Opportunity Date for 200603
Generic Entry Date for 200603*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

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

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 200603-005 Jul 12, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Chubb
Julphar
AstraZeneca
McKesson
Cantor Fitzgerald
Deloitte
Fuji
Teva

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