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Last Updated: October 18, 2019

DrugPatentWatch Database Preview

Details for Patent: 8,465,765

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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 nine patent family members in eight 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,465,765
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Use; Composition; Formulation;

Drugs Protected by US Patent 8,465,765

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 RX Yes Yes   Start Trial   Start Trial 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   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,465,765

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011359405   Start Trial
Australia 2017202955   Start Trial
Brazil 112013020537   Start Trial
Canada 2825991   Start Trial
Denmark 2675438   Start Trial
European Patent Office 2675438   Start Trial
Spain 2721900   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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