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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 |
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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 |
