You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

LATUDA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Latuda, and what generic alternatives are available?

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-eight 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-four 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.

  Try a Trial

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
New York State Psychiatric InstitutePhase 4
Columbia UniversityPhase 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Remedy for integration dysfunction syndrome
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of treatment for mental disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

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

Agent for treatment of schizophrenia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

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

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

Pharmaceutical composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Process for producing imide compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 0611409
Estimated Expiration: ⤷  Try a Trial

Patent: 2020005056
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 06510
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1184489
Estimated Expiration: ⤷  Try a Trial

Patent: 2048734
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 14118
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 84242
Estimated Expiration: ⤷  Try a Trial

Patent: 22783
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 84242
Estimated Expiration: ⤷  Try a Trial

Patent: 22783
Estimated Expiration: ⤷  Try a Trial

France

Patent: C0069
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 08379
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 400051
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2006126681
Estimated Expiration: ⤷  Try a Trial

Patent: 33120
Estimated Expiration: ⤷  Try a Trial

Patent: 85105
Estimated Expiration: ⤷  Try a Trial

Patent: 11126915
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 550
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07014872
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0690
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 84242
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 84242
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 98586
Estimated Expiration: ⤷  Try a Trial

Patent: 07148997
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 84242
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1380088
Estimated Expiration: ⤷  Try a Trial

Patent: 1552033
Estimated Expiration: ⤷  Try a Trial

Patent: 080012306
Estimated Expiration: ⤷  Try a Trial

Patent: 130122019
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 08687
Estimated Expiration: ⤷  Try a Trial

Patent: 35478
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 59020
Estimated Expiration: ⤷  Try a Trial

Patent: 0800197
Estimated Expiration: ⤷  Try a Trial

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
South Korea 20130122019 PHARMACEUTICAL COMPOSITION ⤷  Try a Trial
Austria 431147 ⤷  Try a Trial
Brazil PI0413081 processo para a produção de composto imida ⤷  Try a Trial
China 103180315 Method of treatment for mental disorders ⤷  Try a Trial
Russian Federation 2398586 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Spain 2326078 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006126681 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LATUDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 1490057-5 Sweden ⤷  Try a Trial PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
1884242 CA 2014 00049 Denmark ⤷  Try a Trial 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 C300690 Netherlands ⤷  Try a Trial PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242 C20140030 00118 Estonia ⤷  Try a Trial PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
1884242 132014902294693 Italy ⤷  Try a Trial 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 56/2014 Austria ⤷  Try a Trial PRODUCT NAME: LURASIDON, GEGEBENENFALLS IN FORM SEINER FREIEN BASE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON.; REGISTRATION NO/DATE: EU/1/14/913 20140327
1884242 14C0069 France ⤷  Try a Trial PRODUCT NAME: LURASIDONE, EN PARTICULIER SOUS LA FORME DE L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/14/913 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.