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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.

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;

Drugs Protected by US Patent 8,883,794

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

Non-Orange Book US Patents Family Members 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
8,729,085	Pharmaceutical composition
9,555,027	Pharmaceutical composition

International Family Members for US Patent 8,883,794

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006250340
Brazil	PI0611409
Canada	2606510
China	101184489