Topic

Orange Book

Patent/exclusivity records, therapeutic-equivalence codes, reference-listed drugs, and ANDA planning.

2 articles·Lives underGenerics Approvals·Last updated 2026-05-13

Approvals· May 10, 2026 · 4 min read

Orange Book vs Purple Book: the launch-team read that prevents bad assumptions

Orange Book and Purple Book answer different regulatory questions. Mixing them up creates bad generic, biosimilar, exclusivity, and substitution assumptions.

By Ran Chen#Orange Book #Purple Book #FDA Approval

Generics· May 6, 2026 · 3 min read

Generic entry, ANDA, and 505(b)(2): the commercial difference

ANDA and 505(b)(2) pathways answer different commercial problems. Launch teams should separate therapeutic equivalence, reliance strategy, exclusivity, and payer...

By Ran Chen#Generics #505(b)(2)#Orange Book