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Profile for Tradename: LATUDA

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

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

The generic ingredient in LATUDA is lurasidone hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. There are three tentative approvals for this compound. Additional details are available on the lurasidone hydrochloride profile page.

Summary for Tradename: LATUDA

Suppliers / Packagers: see list25

Pharmacology for Tradename: LATUDA

Clinical Trials for: LATUDA

Lurasidone Low-Dose - High-Dose Study Study
Status: Completed Condition: Schizophrenia

Lurasidone Effects on Tissue Glutamate in Schizophrenia
Status: Recruiting Condition: Schizophrenia; Schizoaffective Disorder

Lurasidone Pediatric Autism Study
Status: Completed Condition: Autism

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects
Status: Completed Condition: Schizophrenia

Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old
Status: Not yet recruiting Condition: Mania; Bipolar I; Bipolar II; Bipolar Spectrum Disorder; Bipolar Disorder

Pediatric Schizophrenia Efficacy and Safety Study
Status: Completed Condition: Schizophrenia

Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
Status: Completed Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychosis NOS; Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive; Bipolar I Disorder; Bipolar II Disorder; Mood Disorder NOS; Severe Major Depression With Psychotic Features; Single Episode Major Depression Without Psychotic Symptoms; Severe Mood Disorder With Psychotic Features

A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Status: Completed Condition: Schizophrenia; Schizoaffective Disorder

Biosignatures of Latuda for Bipolar Depression
Status: Recruiting Condition: Bipolar Depression

Lurasidone Pediatric Pharmacokinetics Study
Status: Completed Condition: Schizophrenia; Autism

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc
lurasidone hydrochloride
TABLET;ORAL200603-002Oct 28, 2010RXNo<disabled><disabled>
Sunovion Pharms Inc
lurasidone hydrochloride
TABLET;ORAL200603-002Oct 28, 2010RXNoRE45573<disabled>Y <disabled>
Sunovion Pharms Inc
lurasidone hydrochloride
TABLET;ORAL200603-004Apr 26, 2012RXNo9,174,975<disabled> <disabled>
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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

International Patent Family for Tradename: LATUDA

Country Document Number Publication Date
European Patent Office0464846Apr 22, 1998
Spain2408687Jun 21, 2013
Russian Federation2007148997Jul 10, 2009
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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