Generics#ANDA#505(j)#product development#infringement

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Paragraph 1,2,3,4
certification
USFDA

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★ At the time of fling 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.
★ In its ANDA application, a generic applicant must submit to FDA one out of four
certifications specified in Act regarding the patents for the RLD.
★ Paragraph-I certification:
❏ 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.
ANDA & Paragraph 1 certification
No patents
listed-Para 1

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Paragraph-II certification:
★ It states that the listed patents have expired.
★ In this case also, FDA may approve the ANDA application immediately. One or more
applicant may enter in the market.
★ In the ANDA application for Paragraph-II certification, applicant’s patent certification
must state that such patent has expired.
Paragraph-III certification:
★ In Paragraph III 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.
★ In the ANDA application for Paragraph-III certification, applicant’s patent certification
must state the date on which such patent will expire.
Paragraph -II & III certifications
Patents
expired
-Para 2
Patents not
expired
will expire on
specific data

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Paragraph-IV certification:
In paragraph IV 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.
Challenging the
innovator