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Serving leading biopharmaceutical companies globally:

UBS
Healthtrust
McKesson
Fish and Richardson
Novartis
QuintilesIMS
Chinese Patent Office
Accenture
Cantor Fitzgerald
Queensland Health

Generated: December 18, 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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lurasidone hydrochloride has seventy-two patent family members in twenty-two countries and fourteen supplementary protection certificates in twelve countries.

There are twenty-six drug master file entries for lurasidone hydrochloride. One supplier is listed for this compound. There are six tentative approvals for this compound.

Pharmacology for lurasidone hydrochloride

Tentative approvals for LURASIDONE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe20MGTABLET;ORAL
u► Subscribe120MGTABLET;ORAL
u► 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 IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-002Oct 28, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-002Oct 28, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-001Oct 28, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-004Apr 26, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-005Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-003Dec 7, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-004Apr 26, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-002Oct 28, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-002Oct 28, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-003Dec 7, 2011RXYesNo► Subscribe► 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
South Korea101380088► Subscribe
HungaryS1400051► Subscribe
China1832946► Subscribe
BrazilPI0611409► Subscribe
European Patent Office1944030► Subscribe
Japan2016094440► Subscribe
Austria543817► Subscribe
World Intellectual Property Organization (WIPO)2012063513► Subscribe
Mexico2007014872► Subscribe
Germany60327634► 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
1884242/01Switzerland► SubscribePRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013
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
2014034Lithuania► SubscribePRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
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
1 5024-2014Slovakia► SubscribePRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
2014034,C1884242Lithuania► SubscribePRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
90057-5Sweden► SubscribePRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
00690Netherlands► SubscribePRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 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
0140030 00118Estonia► SubscribePRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Covington
Mallinckrodt
Cantor Fitzgerald
Fish and Richardson
Accenture
Express Scripts
UBS
Teva
Chubb

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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