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Details for Patent: 8,778,390

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Patent 8,778,390 protects QUILLIVANT XR and is included in one NDA. There has been one Paragraph IV challenge on Quillivant XR. There are three tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has five patent family members in five countries.

Summary for Patent: 8,778,390

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:14/016,384
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Formulation; Use; Delivery;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 5th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Nextwave Pharms
QUILLIVANT XR
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYes8,778,390► subscribeY TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR CLAIM 23
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Non-Orange Book Patents for Patent: 8,778,390

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
8,956,649Orally effective methylphenidate extended release powder and aqueous suspension product► subscribe
8,287,903Orally effective methylphenidate extended release powder and aqueous suspension product► subscribe
9,040,083Orally effective methylphenidate extended release powder and aqueous suspension product► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,778,390

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Israel227734► subscribe
European Patent Office2675438► subscribe
Canada2825991► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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