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Details for Patent: 8,679,533

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Patent 8,679,533 protects MIRAPEX ER and is included in one NDA. There have been two Paragraph IV challenges on Mirapex ER. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has one hundred and thirty-four patent family members in forty-three countries.

Summary for Patent: 8,679,533

Title:Pramipexole once-daily dosage form
Abstract: An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.
Inventor(s): Lee; Ernest J. (Kalamazoo, MI), Bredael; Gerard M. (Portage, MI), Baldwin; John R. (Kalamazoo, MI), Cox; Steven R. (Schoolcraft, MI), Heintz; Mark J. (Portage, MI)
Assignee: Pharmacia Corporation (Peapack, NJ)
Application Number:10/626,275
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 73rd 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
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-001Feb 19, 2010RXYes8,679,533► subscribeY TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-002Feb 19, 2010RXNo8,679,533► subscribeY TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010RXNo8,679,533► subscribeY TREATMENT OF PARKINSON'S DISEASE
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Non-Orange Book Patents for Patent: 8,679,533

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
8,399,016Sustained-release tablet composition of pramipexole► 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: 8,679,533

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Ukraine80831► subscribe
Taiwan200412962► subscribe
Taiwan200412961► 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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