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Serving leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
QuintilesIMS
US Department of Justice
Cipla
Johnson and Johnson
Moodys
Federal Trade Commission
Julphar
Fish and Richardson

Generated: January 20, 2018

DrugPatentWatch Database Preview

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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in twenty-two countries.

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

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 200603-002 Oct 28, 2010 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for LATUDA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg ➤ Subscribe 10/28/2014

Non-Orange Book US Patents for Latuda

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,605,260 Process for producing imide compound ➤ Subscribe
5,780,632 Imide derivatives and their production and use ➤ Subscribe
9,815,827 Agent for treatment of schizophrenia ➤ Subscribe
9,827,242 Method of treatment for mental disorders ➤ Subscribe
8,258,139 Method of treatment for mental disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Latuda

Supplementary Protection Certificates for Latuda

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242/01 Switzerland ➤ Subscribe PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013
/2014 Austria ➤ Subscribe PRODUCT NAME: LURASIDON, GEGEBENENFALLS IN FORM SEINER FREIEN BASE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON.; REGISTRATION NO/DATE: EU/1/14/913 20140327
2014 00049 Denmark ➤ Subscribe 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
1 5024-2014 Slovakia ➤ Subscribe PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
0690 Netherlands ➤ Subscribe PRODUCT NAME: LURASIDON HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/913 20140327
C0069 France ➤ Subscribe 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
00690 Netherlands ➤ Subscribe PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
90057-5 Sweden ➤ Subscribe PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
0140030 00118 Estonia ➤ Subscribe PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
14/051 Ireland ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Citi
Julphar
Baxter
Daiichi Sankyo
Cipla
Express Scripts
Cerilliant
US Army

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