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Details for Patent: 8,298,576

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Patent 8,298,576 protects TROKENDI XR and is included in one NDA. There have been two Paragraph IV challenges on Trokendi XR.

This patent has eleven patent family members in eight countries.

Summary for Patent: 8,298,576

Title:Sustained-release formulations of topiramate
Abstract: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.
Inventor(s): Liang; Likan (Boyds, MD), Wang; Hua (Clarksville, MD), Bhatt; Padmanabh P. (Rockville, MD), Vieira; Michael L. (Gaithersburg, MD)
Assignee: Supernus Pharmaceuticals, Inc. (Rockville, MD)
Application Number:11/941,475
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 85th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Supernus Pharms
TROKENDI XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL201635-001Aug 16, 2013RXNo8,298,576► subscribeY TREATMENT OF EPILEPSY
Supernus Pharms
TROKENDI XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL201635-002Aug 16, 2013RXNo8,298,576► subscribeY TREATMENT OF EPILEPSY
Supernus Pharms
TROKENDI XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL201635-003Aug 16, 2013RXNo8,298,576► subscribeY TREATMENT OF EPILEPSY
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Non-Orange Book Patents for Patent: 8,298,576

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
8,992,989Sustained-release formulations of topiramate► subscribe
8,298,580Sustained-release formulations of topiramate► subscribe
8,663,683Sustained-release formulations of topiramate► 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: 8,298,576

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2007319141► subscribe
Canada2618240► subscribe
Germany07870164► 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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