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Last Updated: June 30, 2022

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-six patent family members in twenty-three countries.

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

Drug patent expirations by year for LATUDA
Drug Prices for LATUDA

See drug prices for LATUDA

Drug Sales Revenue Trends for LATUDA

See drug sales revenues for LATUDA

Recent Clinical Trials for LATUDA

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

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

See all LATUDA clinical trials

Pharmacology for LATUDA
Anatomical Therapeutic Chemical (ATC) Classes 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Remedy for integration dysfunction syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treatment for mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Agent for treatment of schizophrenia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Agent for treatment of schizophrenia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of treatment for mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA

Method of treatment for mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for producing imide compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0611409
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06510
Estimated Expiration: See Plans and Pricing

China

Patent: 1184489
Estimated Expiration: See Plans and Pricing

Patent: 2048734
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14118
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 84242
Estimated Expiration: See Plans and Pricing

Patent: 22783
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 84242
Estimated Expiration: See Plans and Pricing

Patent: 22783
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 08379
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 400051
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2006126681
Estimated Expiration: See Plans and Pricing

Patent: 33120
Estimated Expiration: See Plans and Pricing

Patent: 85105
Estimated Expiration: See Plans and Pricing

Patent: 11126915
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 550
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07014872
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0690
Estimated Expiration: See Plans and Pricing

Poland

Patent: 84242
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 84242
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 98586
Estimated Expiration: See Plans and Pricing

Patent: 07148997
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 84242
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1380088
Estimated Expiration: See Plans and Pricing

Patent: 1552033
Estimated Expiration: See Plans and Pricing

Patent: 080012306
Estimated Expiration: See Plans and Pricing

Patent: 130122019
Estimated Expiration: See Plans and Pricing

Spain

Patent: 08687
Estimated Expiration: See Plans and Pricing

Patent: 35478
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 59020
Estimated Expiration: See Plans and Pricing

Patent: 0800197
Estimated Expiration: See Plans and Pricing

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
China 102048734 Pharmaceutical composition See Plans and Pricing
Taiwan I359020 See Plans and Pricing
South Korea 20060052840 PROCESS FOR PRODUCING IMIDE COMPOUND See Plans and Pricing
China 103180315 Method of treatment for mental disorders See Plans and Pricing
Germany 69129282 See Plans and Pricing
Hungary S1400051 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LATUDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 C20140030 00118 Estonia See Plans and Pricing PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
1884242 PA2014034,C1884242 Lithuania See Plans and Pricing PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242 132014902294693 Italy See Plans and Pricing PRODUCT NAME: LURASIDONE, OPZIONALMENTE IN FORMA DI BASE LIBERA O DI SUOI SALI FARMACEUTICAMENTE ACCETTABILI(LATUDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/913, 20140321
1884242 92550 Luxembourg See Plans and Pricing PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
1884242 CA 2014 00049 Denmark See Plans and Pricing 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 CR 2014 00049 Denmark See Plans and Pricing PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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