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Serving leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Harvard Business School
Dow
Colorcon
McKinsey
US Department of Justice
Cantor Fitzgerald
Merck
Citi

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,883,794

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Which drugs does patent 8,883,794 protect, and when does it expire?


Patent 8,883,794 protects LATUDA and is included in one NDA. There has been one Paragraph IV challenge on Latuda.

Protection for LATUDA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-seven patent family members in nineteen countries.

Summary for Patent: 8,883,794

Title:Pharmaceutical composition
Abstract: A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethyle- ne-butyl]-(1'R,2'S,3'R,4'S)-2,3-bicyclo[2,2,1]-heptanedicarboxylmide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.
Inventor(s): Fujihara; Kazuyuki (Suzuka, JP)
Assignee: Sumitomo Dainippon Pharma Co., Ltd. (Osaka, JP)
Application Number:14/183,283
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-003Dec 7, 2011RXYesNo► Subscribe► Subscribe► SubscribeY
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-001Oct 28, 2010RXYesYes► Subscribe► Subscribe► SubscribeY
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-005Jul 12, 2013RXYesNo► Subscribe► Subscribe► SubscribeY
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-002Oct 28, 2010RXYesNo► Subscribe► Subscribe► SubscribeY
Sunovion Pharms IncLATUDAlurasidone hydrochlorideTABLET;ORAL200603-004Apr 26, 2012RXYesNo► Subscribe► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 8,883,794

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
8,729,085Pharmaceutical composition► Subscribe
9,555,027Pharmaceutical composition► 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 Patent: 8,883,794

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
South Korea101380088► Subscribe
South Korea20080012306► Subscribe
Japan5285105► Subscribe
Japan2011126915► Subscribe
Japan4733120► Subscribe
HungaryS1400051► Subscribe
JapanWO2006126681► Subscribe
Hong Kong1108379► Subscribe
Spain2535478► Subscribe
Spain2408687► 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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Serving leading biopharmaceutical companies globally:

Teva
Julphar
Harvard Business School
Medtronic
Farmers Insurance
Cipla
Mallinckrodt
Deloitte
Express Scripts
Cantor Fitzgerald

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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