Regulatory Open Forum

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  • 1.  Paragraph I or II Certification

    Posted 30-Jun-2015 10:13

    If the patent on a drug expired many, many years ago so that it is no longer listed in the Orange Book, does the Applicant for a 505(b)(2) application file a Paragraph I or II certification?

    Thank you!
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    David Lucking
    FL
    United States
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  • 2.  RE: Paragraph I or II Certification

    Posted 06-Aug-2015 08:31

    Hi David,

    As per my recent experience on this topic with FDA. FDA is recommending to include "A Statement of no relevant Patents". this is also mentioned in the CFR and also option in the 356h.

    Best regards,

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    Sudhir Kaushal RAC
    Sr. Manager
    Lupin Pharmaceuticals Inc.
    Baltimore MD
    United States
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    Original Message