Paragraph IV and the 180-day exclusivity

For each listed patent, an abbreviated new drug application (ANDA) certifies one of four things: that the patent information has not been filed (I); that the patent has expired (II); the patent's expiration date (III); or that the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug for which the application is submitted (IV). These are paragraphs (I) to (IV) of 21 USC 355(j)(2)(A)(vii).

For a method-of-use patent, the applicant can instead state that the patent does not claim the use it is seeking approval for (21 USC 355(j)(2)(A)(viii)).

An applicant with a Paragraph IV certification must give notice to the patent owner and to the holder of the approved application, not later than 20 days after the date of the postmark on the notice with which FDA informs the applicant that the application has been filed (21 USC 355(j)(2)(B)(i), (ii)(I)).

If an action for infringement is brought before 45 days have passed from receipt of the notice, the statute makes approval effective on the expiration of a 30-month period beginning on the date the notice is received, or such shorter or longer period as the court may order, and sets other dates where a court decides the patent question before then (21 USC 355(j)(5)(B)(iii); 21 CFR 314.107(b)(3)).

For a drug containing a new chemical entity, no ANDA may be submitted for five years from the first approval, except that one with a Paragraph IV certification may be submitted after four years (21 USC 355(j)(5)(F)(ii); 21 CFR 314.108(b)(2)). Where pediatric exclusivity applies, the statute reads those four years as four and a half, and the five as five and a half (21 USC 355a(b)(1)(A)(i)(I)).

The app's NCE-1 is the one date it computes: the NCE date minus one calendar year, shown as computed. It is not adjusted for pediatric exclusivity, under which the statute reads the four years as four and a half (21 USC 355a(b)(1)(A)(i)(I)); where a PED exclusivity is listed on the same product, the trace says so in a note.

A first applicant is one that, on the first day a substantially complete ANDA with a Paragraph IV certification is submitted, submits one and lawfully maintains the certification; there can be more than one (21 USC 355(j)(5)(B)(iv)(II); FDA's Paragraph IV list page).

A later applicant's approval may take effect only 180 days after the first commercial marketing by a first applicant (21 USC 355(j)(5)(B)(iv)(I)), and FDA does not approve a later ANDA while a first applicant is eligible or during that period (21 CFR 314.107(c)(1)). The statute lists events on which eligibility is forfeited (21 USC 355(j)(5)(D)).

The list covers drug products for which one or more substantially complete ANDAs with a Paragraph IV certification have been submitted. For each it gives the ingredient, dosage form and strength; the reference listed drug and its NDA number; the date of the first Paragraph IV submission; the number of potential first applicants; the 180-day status and the date it was posted; the date of the first approval of a first applicant; the date of first commercial marketing; and the expiration date of the last qualifying patent.

FDA's page states what the list does not do. The last qualifying patent date does not reflect pediatric exclusivity. A blank 180-day status means FDA has made no determination. Columns added in June 2019 are filled for older entries only as practicable. FDA may delay adding or revising an entry while related issues are unresolved, and FDA makes its decisions on application data, not on the list.

The list's columns name no ANDA applicant, no patent number and no litigation. A product that is not on it may still have had a Paragraph IV certification submitted; the app never reads absence as "no Paragraph IV". The app may also show no row for a product that is on the list, in a row kept apart because the list gives no NDA number the app can match.