Details for Patent: 8,883,794

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 thirty-four patent family members in twenty-one 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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,883,794
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	Submissiondate
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	AB	RX	Yes	Yes					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No					Y

International Family Members for US Patent 8,883,794

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006250340
Brazil	122020005056
Brazil	PI0611409
Canada	2606510
China	101184489
China	102048734
Cyprus	1114118