patents Para 4 filing litigation USFDA ANDA 505(J) generics USA PHARMACEUTICALCONCEPT PC
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PARA 1 filing
In ANDA application, a generic applicant must submit to FDA one out of 4 certifications specified in Act regarding the patents for the RLD.
At the time of filing an ANDA application ,
an applicant must provide, information related to any patents listed for the reference listed drug (RLD) in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations which is commonly called as the Orange Book.
It states that there are no patents listed.
In this case FDA may approve the ANDA application immediately. One or more applicant may enter.
In the ANDA application for Paragraph-I certification applicant must certify that such patent information has not been submitted by the new drug application (NDA) holder (Innovator) for listing in the Orange Book.
Para 2
It states that the listed patents have expired.
In this case also, FDA may approve the ANDA application immediately. 1/more applicants may enter in the market.
In the ANDA application for Paragraph-II certification, applicant’s patent certification must state that such patent has expired.
In Paragraph 3 certification the
listed patents is not expired and
will be expired on a specific date.
In this case, FDA may approve the ANDA application which is effective on the date of expiration of the patent. One or more applicant may enter.
Paragraph- 4 certification:
In paragraph 4 certification generic product applicant does not infringe on the listed patents or that those patents are not enforceable.
In this case, Generic applicant (ANDA) provides notice to innovator/patent holder. Entry of first to file may or may not occur.
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