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Details for Patent: 8,465,765
Which drugs does patent 8,465,765 protect, and when does it expire?
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
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.
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
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 |