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Serving 500+ biopharmaceutical companies globally:

UBS
Moodys
McKinsey
Fish and Richardson
US Department of Justice
Covington
Medtronic
QuintilesIMS
Chinese Patent Office
Harvard Business School

Generated: June 23, 2017

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Lurasidone hydrochloride - Generic Drug Details

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What are the generic drug sources for lurasidone hydrochloride and what is the scope of lurasidone hydrochloride freedom to operate?

Lurasidone hydrochloride
is the generic ingredient in one branded drug marketed by Sunovion Pharms Inc and is included in one NDA. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lurasidone hydrochloride has sixty-five patent family members in twenty-two countries.

There are twenty-three drug master file entries for lurasidone hydrochloride. Two suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: lurasidone hydrochloride

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list23
Suppliers / Packagers: see list2
Bulk Api Vendors: see list36
Clinical Trials: see list2,299
Patent Applications: see list93
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lurasidone hydrochloride at DailyMed

Pharmacology for Ingredient: lurasidone hydrochloride

Tentative approvals for LURASIDONE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe20MGTABLET;ORAL
► Subscribe► Subscribe120MGTABLET;ORAL
► Subscribe► Subscribe80MGTABLET;ORAL
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;ORAL200603-005Jul 12, 2013RXYesNo► Subscribe► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-004Apr 26, 2012RXYesNoRE45573*PED► Subscribe ► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-001Oct 28, 2010RXYesYes9,174,975*PED► SubscribeY► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-002Oct 28, 2010RXYesNo8,729,085*PED► SubscribeY► Subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-002Oct 28, 2010RXYesNo8,883,794*PED► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lurasidone hydrochloride

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 Ingredient: lurasidone hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006126681► Subscribe
Taiwan200800197► Subscribe
Australia2004259305► Subscribe
JapanWO2005009999► 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: LURASIDONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2014034Lithuania► SubscribePRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
550Luxembourg► SubscribePRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
90057-5Sweden► SubscribePRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
1884242/01Switzerland► SubscribePRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Cipla
McKinsey
Julphar
Mallinckrodt
US Department of Justice
Merck
Baxter
UBS
Argus Health

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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