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Generated: September 23, 2019

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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 Submissiondate
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,679,533

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 2201 ➤ Sign Up
African Regional IP Organization (ARIPO) 2223 ➤ Sign Up
Argentina 040680 ➤ Sign Up
Argentina 040681 ➤ Sign Up
Argentina 040682 ➤ Sign Up
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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