Explainers

Short, cited explanations of the FDA files the app reads: what each column means, what each protection bars, and what the files do not record.

• Paragraph IV and the 180-day exclusivity

  What a Paragraph IV certification is, how the first applicant's 180-day exclusivity works, and what FDA's Paragraph IV list does and does not record.

• Purple Book exclusivities for biologics

  The reference product, first interchangeable and orphan exclusivities FDA lists for biologics, and how to read the Purple Book's dates and blanks.

• How to read the Orange Book data files

  The three files FDA publishes, what each column means, and how to read *PED rows, use codes, the delist flag and dates written in words.

• Patents vs FDA exclusivity: how they differ

  Why one product can carry several patent and exclusivity dates, what each kind governs, and why we show FDA's rows rather than one date.