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LATUDA Drug Profile

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Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in twenty countries.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the lurasidone hydrochloride profile page.

Summary for Tradename: LATUDA

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: LATUDA

Clinical Trials for: LATUDA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-002Oct 28, 2010RXNoJun 28, 2016
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-002Oct 28, 2010RXNo8,883,794May 26, 2026Y
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-004Apr 26, 2012RXNo9,174,975Jun 25, 2026
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Paragraph IV activity for: LATUDA

Drugname Dosage Strength RLD Submissiondate
lurasidone hydrochlorideTablets20 mg, 40 mg, 60 mg, 80 mg, and 120 mgLatuda10/28/2014

Non-Orange Book Patents for Tradename: LATUDA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,780,632 Imide derivatives and their production and use<disabled in preview>
7,605,260Process for producing imide compound<disabled in preview>
8,258,139Method of treatment for mental disorders<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LATUDA

Country Document Number Estimated Expiration
South Korea20130122019<disabled in preview>
Mexico2007014872<disabled in preview>
China103180315<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LATUDA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00690Netherlands<disabled>PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
90057-5Sweden<disabled>PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
550Luxembourg<disabled>PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
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