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Details for Patent: 8,465,765

Which drugs does patent 8,465,765 protect, and when does it expire?

Patent 8,465,765 protects QUILLIVANT XR and is included in one NDA.

This patent has six patent family members in five countries.

Summary for Patent: 8,465,765

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:	13/611,183
Patent Claim Types: see list of patent claims	Compound; Dosage form; Use; Composition; Formulation;

Drugs Protected by US Patent 8,465,765

Glossary

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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
Nextwave Pharms	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2	➤ Sign Up
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

Non-Orange Book US Patents Family Members for Patent 8,465,765

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.

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Patent No.	Title	Estimated Patent Expiration
8,778,390	Orally effective methylphenidate extended release powder and aqueous suspension product	➤ Sign Up
8,956,649	Orally effective methylphenidate extended release powder and aqueous suspension product	➤ Sign Up
8,287,903	Orally effective methylphenidate extended release powder and aqueous suspension product	➤ Sign Up
9,040,083	Orally effective methylphenidate extended release powder and aqueous suspension product	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Family Members for US Patent 8,465,765

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Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011359405	➤ Sign Up
Australia	2017202955	➤ Sign Up
Canada	2825991	➤ Sign Up
European Patent Office	2675438	➤ Sign Up
Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration

Summary for Patent: 8,465,765

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