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Serving 500+ biopharmaceutical companies globally:

McKesson
UBS
Cerilliant
Moodys
Cipla
McKinsey
Daiichi Sankyo
Express Scripts
Farmers Insurance
Covington

Generated: September 26, 2017

DrugPatentWatch Database Preview

LATUDA Drug Profile

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What is the patent landscape for Latuda, 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 sixty-six patent family members in twenty-two countries.

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

Summary for Tradename: LATUDA

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list35
Clinical Trials: see list21
Patent Applications: see list63
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LATUDA at DailyMed

Pharmacology for Tradename: 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;ORAL200603-002Oct 28, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-005Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-004Apr 26, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-004Apr 26, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-005Jul 12, 2013RXYesNo► Subscribe► SubscribeY► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-005Jul 12, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-003Dec 7, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-001Oct 28, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-005Jul 12, 2013RXYesNo► Subscribe► SubscribeY► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-002Oct 28, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for LATUDA

Drugname Dosage Strength RLD Submissiondate
lurasidone hydrochlorideTablets20 mg, 40 mg, 60 mg, 80 mg, and 120 mgLatuda10/28/2014

Non-Orange Book Patents for Tradename: 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
5,780,632 Imide derivatives and their production and use► Subscribe
7,605,260Process for producing imide compound► Subscribe
8,258,139Method of treatment for mental disorders► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LATUDA

Country Document Number Estimated Expiration
Austria543817► Subscribe
South Korea101380088► Subscribe
Luxembourg92550► Subscribe
TaiwanI359020► Subscribe
Spain2326078► Subscribe
Russian Federation2007148997► Subscribe
South Korea101552033► Subscribe
Greece3026697► Subscribe
European Patent Office1944030► Subscribe
Japan4733120► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LATUDA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90057-5Sweden► SubscribePRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
1 5024-2014Slovakia► SubscribePRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242/01Switzerland► SubscribePRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013
0140030 00118Estonia► SubscribePRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
550Luxembourg► SubscribePRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
2014034,C1884242Lithuania► SubscribePRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
2014000092Germany► SubscribePRODUCT NAME: LURASIDON, INSBESONDERE EINE PHARMAZEUTISCH VERTRAEGLICHE SALZFORM UND IM SPEZIELLEN DAS HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
2014 00049Denmark► SubscribePRODUCT 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
C0069France► SubscribePRODUCT 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
14/051Ireland► SubscribePRODUCT NAME: LURASIDONE, PARTICULARLY A PHARMACEUTICALLY ACCEPTABLE SALT FORM AND ESPECIALLY THE HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Deloitte
US Army
Colorcon
Merck
Healthtrust
UBS
Express Scripts
Citi
Accenture
Covington

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 verifification 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.

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