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Last Updated: August 13, 2020

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LATUDA Drug 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. Two 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

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Drug Sales Revenue Trends for LATUDA

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Recent Clinical Trials for LATUDA

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

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Pharmacology for LATUDA
Paragraph IV (Patent) Challenges for LATUDA
Tradename Dosage Ingredient NDA Submissiondate
LATUDA TABLET;ORAL lurasidone hydrochloride 200603 2014-10-28

US Patents and Regulatory Information for LATUDA

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 200603-004 Apr 26, 2012 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No   Start Trial   Start Trial   Start 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

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   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LATUDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 C300690 Netherlands   Start 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 14C0069 France   Start 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
1884242 PA2014034 Lithuania   Start Trial PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242 56/2014 Austria   Start Trial PRODUCT NAME: LURASIDON, GEGEBENENFALLS IN FORM SEINER FREIEN BASE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON.; REGISTRATION NO/DATE: EU/1/14/913 20140327
1884242 251 5024-2014 Slovakia   Start Trial PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Dow
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Johnson and Johnson
Harvard Business School

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