Paragraph 1,2,3,4 certification usfda

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

1. Paragraph 1,2,3,4 certification USFDA

2. 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

3. 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

4. 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