How many types of patent certifications are available to file an ANDA?

There are four types of patent certification.

When submitting an ANDA, generic drug manufacturers need to submit one of the following four statements in accordance with the provisions of the Orange Book:

(1) the Orange Book contains no patent information relevant to their ANDA (“Paragraph I certification”).

(2) the listed patents have expired (“Paragraph II certification”).

(3) the applicant will not enter the market until the listed patents.

expire (“Paragraph III certification”).

(4) the applicant believes that the listed patents are invalid or will not be infringed by the applicant's generic compositions (“Paragraph IVcertification”).