Generics· June 20, 2026 · 10 min read
Discontinued RLDs and Reference Standards: Generic Developer Workflow
By Ran Chen#Orange Book#ANDA Approval#Generic Entry
Topic
ANDA Approval
Abbreviated New Drug Application approval, therapeutic equivalence, exclusivity, generic launch timing, and substitution.
Generics· June 16, 2026 · 12 min read
Single-source transdermal patches in the Orange Book: 385 products, 43% no generic
By Ran Chen#Orange Book#ANDA Approval#Generic Entry
Generics· June 14, 2026 · 10 min read
Single-source inhaled drugs in the Orange Book: 506 products, 65% no generic
By Ran Chen#Orange Book#ANDA Approval#Generic Entry
Generics· June 14, 2026 · 11 min read
Single-source ophthalmic drops in the Orange Book: 67 molecules, 11% AB-substitutable
By Ran Chen#Orange Book#ANDA Approval#Generic Entry
Generics· June 13, 2026 · 17 min read
Orange Book TE codes: how to tell whether a generic can actually be substituted
By Ran Chen#Orange Book#ANDA Approval#Generics
Generics· June 11, 2026 · 10 min read
Orange Book therapeutic equivalence: 48K products, 55% single-source, AB dominates
By Ran Chen#ANDA Approval#Orange Book#Generic Entry
Generics· June 9, 2026 · 9 min read
Dapagliflozin generic entry: Farxiga ANDA playbook and formulary impact
By Ran Chen#SGLT2 Inhibitor#ANDA Approval#Orange Book
Generics· May 27, 2026 · 12 min read
Hatch-Waxman 180-day exclusivity forfeiture guide
By Ran Chen#Generics#ANDA Approval#Orange Book
Approvals· May 25, 2026 · 8 min read