Details for Patent: 8,287,903

Which drugs does patent 8,287,903 protect, and when does it expire?

Patent 8,287,903 protects QUILLIVANT XR and QUILLICHEW ER and is included in two NDAs.

This patent has nine patent family members in eight countries.

Summary for Patent: 8,287,903

Title:	Orally effective methylphenidate extended release powder and aqueous suspension product
Abstract:	An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Inventor(s):	Mehta; Ketan (Cranbury, NJ), Tu; Yu-Hsing (West Windsor, NJ), Perumal; Ashok (Edison, NJ)
Assignee:	Tris Pharma Inc (Monmouth Junction, NJ)
Application Number:	13/244,706
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,287,903
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Formulation;

Drugs Protected by US Patent 8,287,903

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No			Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-002	Dec 4, 2015		RX	Yes	No			Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes			Y

International Family Members for US Patent 8,287,903

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011359405
Australia	2017202955
Brazil	112013020537
Canada	2825991