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Last Updated: October 10, 2024

LATUDA Drug Patent Profile


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When do Latuda patents expire, and when can generic versions of Latuda launch?

Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Latuda

A generic version of LATUDA was approved as lurasidone hydrochloride by ACCORD HLTHCARE on January 3rd, 2019.

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Drug patent expirations by year for LATUDA
Drug Prices for LATUDA

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Drug Sales Revenue Trends for LATUDA

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Recent Clinical Trials for LATUDA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
New York State Psychiatric InstitutePhase 4
Columbia UniversityPhase 4
Astellas Pharma Global Development, Inc.Phase 2

See all LATUDA clinical trials

Pharmacology for LATUDA
Paragraph IV (Patent) Challenges for LATUDA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LATUDA Tablets lurasidone hydrochloride 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg 200603 14 2014-10-28

US Patents and Regulatory Information for LATUDA

LATUDA is protected by eleven US patents.

Patents protecting LATUDA

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Remedy for integration dysfunction syndrome
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of treatment for mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Agent for treatment of schizophrenia
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Agent for treatment of schizophrenia
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of treatment for mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA

Method of treatment for mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Process for producing imide compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LATUDA

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

International Patents for LATUDA

When does loss-of-exclusivity occur for LATUDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06250340
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0611409
Patent: preparação oral e método de granulação de uma mistura em pó
Estimated Expiration: ⤷  Sign Up

Patent: 2020005056
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 06510
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1184489
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Patent: 2048734
Patent: Pharmaceutical composition
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Cyprus

Patent: 14118
Estimated Expiration: ⤷  Sign Up

Patent: 14039
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 84242
Estimated Expiration: ⤷  Sign Up

Patent: 22783
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 84242
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT LE LURASIDONE (PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE)
Estimated Expiration: ⤷  Sign Up

Patent: 22783
Patent: Composition pharmaceutique (Pharmaceutical Composition)
Estimated Expiration: ⤷  Sign Up

France

Patent: C0069
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 08379
Patent: PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 400051
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2006126681
Patent: 医薬品組成物
Estimated Expiration: ⤷  Sign Up

Patent: 33120
Estimated Expiration: ⤷  Sign Up

Patent: 85105
Estimated Expiration: ⤷  Sign Up

Patent: 11126915
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 550
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07014872
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0690
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 84242
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 84242
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 98586
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITIONS)
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Patent: 07148997
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 84242
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1380088
Estimated Expiration: ⤷  Sign Up

Patent: 1552033
Estimated Expiration: ⤷  Sign Up

Patent: 080012306
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Patent: 130122019
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 08687
Estimated Expiration: ⤷  Sign Up

Patent: 35478
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 59020
Estimated Expiration: ⤷  Sign Up

Patent: 0800197
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LATUDA around the world.

Country Patent Number Title Estimated Expiration
Canada 2606510 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
Japan 2013541582 ⤷  Sign Up
Canada 2046429 DERIVES D'IMIDE; PREPARATION ET UTILISATION (IMIDE DERIVATIVES, AND THEIR PRODUCTION AND USE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LATUDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 CA 2014 00049 Denmark ⤷  Sign Up PRODUCT NAME: LURASIDON, EVENTUELT I FORM AF DEN FRIE BASE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER LURASIDONHYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140321
1884242 2014/051 Ireland ⤷  Sign Up PRODUCT NAME: LURASIDONE, PARTICULARLY A PHARMACEUTICALLY ACCEPTABLE SALT FORM AND ESPECIALLY THE HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
1884242 C 2014 038 Romania ⤷  Sign Up PRODUCT NAME: LURASIDONA, OPTIONAL SUB FORMA BAZEI EI LIBERE SAU CA SARURIACCEPTABILE FARMACEUTIC ALREA (EEA): EU/1/14/913; DATE OF FIRST AUTHORISATION IN EEA: 20140321 E ACESTEIA, IN SPECIAL CLORHIDRAT DE LURASIDONA -C28H36N4O2S; NATIONAL AUTHORISATION NUMBER: EU/1/14/913; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC A
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.