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Serving leading biopharmaceutical companies globally:

Covington
Teva
Julphar
Argus Health
Dow
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Baxter
QuintilesIMS
AstraZeneca
UBS

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,679,533

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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;

Drugs Protected by US Patent 8,679,533

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-001 Feb 19, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y TREATMENT OF PARKINSON'S DISEASE ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up Y TREATMENT OF PARKINSON'S DISEASE ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up Y TREATMENT OF PARKINSON'S DISEASE ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y TREATMENT OF PARKINSON'S DISEASE ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-004 Feb 19, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up Y TREATMENT OF PARKINSON'S DISEASE ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y TREATMENT OF PARKINSON'S DISEASE ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up Y TREATMENT OF PARKINSON'S DISEASE ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members 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
8,399,016 Sustained-release tablet composition of pramipexole ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,679,533

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Tunisia SN05020 ➤ Sign Up
Tunisia SN05019 ➤ Sign Up
Slovenia 2289514 ➤ Sign Up
Slovenia 1536792 ➤ Sign Up
Slovenia 1531814 ➤ Sign Up
Singapore 177011 ➤ Sign Up
Russian Federation 2292873 ➤ Sign Up
Russian Federation 2005101639 ➤ Sign Up
Serbia 52764 ➤ Sign Up
Serbia 115104 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Fuji
McKesson
Mallinckrodt
Boehringer Ingelheim
Cerilliant
Farmers Insurance
Chubb
Healthtrust

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