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Details for Patent: 8,454,998

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Patent 8,454,998 protects RYTARY and is included in one NDA. There have been two Paragraph IV challenges on Rytary.

This patent has seventeen patent family members in ten countries.

Summary for Patent: 8,454,998

Title:Controlled release formulations of levodopa and uses thereof
Abstract: The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
Inventor(s): Hsu; Ann (Los Altos Hills, CA), Kou; Jim H. (San Jose, CA), Alani; Laman (Hillsborough, CA)
Assignee: Impax Laboratories, Inc. (Hayward, CA)
Application Number:13/367,230
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th 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
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXNo8,454,998► subscribeY TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXNo8,454,998► subscribeY TREATMENT OF PARKINSON'S DISEASE
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXNo8,454,998► subscribeY TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
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Non-Orange Book Patents for Patent: 8,454,998

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
8,557,283Controlled release formulations of levodopa and uses thereof► subscribe
9,089,607Controlled release formulations of levodopa and uses thereof► subscribe
9,089,608Controlled release formulations of levodopa and uses thereof► 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: 8,454,998

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2008343787► subscribe
Canada2711014► subscribe
China101910113► 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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