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Details for Patent: 5,837,284

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Patent 5,837,284 protects FOCALIN XR and RITALIN LA and is included in two NDAs. There have been zero Paragraph IV challenges on Focalin XR and There are six tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has thirty-seven patent family members in fifteen countries.

Summary for Patent: 5,837,284

Title: Delivery of multiple doses of medications
Abstract:Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.
Inventor(s): Mehta; Atul M. (Ramsey, NJ), Zeitlin; Andrew L. (Millington, NJ), Dariani; Maghsoud M. (Fanwood, NJ)
Assignee:
Application Number:08/892,190
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 6th percentile
Forward Citations: 20th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-001May 26, 2005RXNo5,837,284► subscribeY
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005RXNo5,837,284► subscribeY
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006RXNo5,837,284► subscribeY
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Non-Orange Book Patents for Patent: 5,837,284

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
5,908,850 Method of treating attention deficit disorders with d-threo methylphenidate► subscribe
6,355,656 Phenidate drug formulations having diminished abuse potential► subscribe
6,255,325 Chronic, bolus administration of D-threo methylphenidate► 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: 5,837,284

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria306266► subscribe
Austria368458► subscribe
Australia2002318302► 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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