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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Citi
Julphar
US Army
Accenture
Medtronic
Merck
McKinsey
Queensland Health

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,454,998

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Which drugs does patent 8,454,998 protect, and when does it expire?


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

This patent has twenty-two patent family members in eleven 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;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXYesNo► Subscribe► 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, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF PARKINSON'S DISEASE
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF PARKINSON'S DISEASE
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
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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
9,463,246Controlled release formulations of levodopa and uses thereof► Subscribe
8,377,474Controlled 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
9,533,046Controlled release formulations of levodopa and uses thereof► Subscribe
8,557,283Controlled 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
European Patent Office2234963► Subscribe
Israel206756► Subscribe
Israel248520► Subscribe
Japan2011507956► Subscribe
Japan2015187178► Subscribe
Japan2017014295► Subscribe
Japan5783725► 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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Serving leading biopharmaceutical companies globally:

Moodys
Teva
Novartis
Mallinckrodt
Daiichi Sankyo
US Department of Justice
Healthtrust
Harvard Business School
Chubb
Merck

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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