Generics· August 18, 2026 · 14 min read
Generic Wakix Approved but Cannot Launch Until 2030: The Orange Book Fence
By Ran Chen#Orange Book#Generics#Generic Entry
Section
Generics
ANDA strategy, Orange Book records, therapeutic equivalence, exclusivity, and price erosion.
32 articles · Last updated
Generics· July 25, 2026 · 21 min read
FDA Green Book by the Numbers (2026): 2,882 Approved Animal Drugs, Zoetis Leads
By Ran Chen#FDA Approval#Generics#NADA
Generics· July 15, 2026 · 29 min read
2026–2027 Generic Launch Scorecard: Which Patent Cliffs Are Worth Filing
By Ran Chen#Orange Book#Generic Entry#ANDA Approval
Generics· July 2, 2026 · 18 min read
Why Generic Jardiance Has Not Launched: Empagliflozin Patent Cliff
By Ran Chen#Generic Entry#Orange Book#SGLT2 Inhibitor
Generics· June 29, 2026 · 18 min read
Generic Xarelto Entry: Orange Book Patents and NADAC Price Erosion
By Ran Chen#Generics#Orange Book#Generic Entry
Generics· June 27, 2026 · 18 min read
Generic Aubagio Market: ANDA Litigation Settlements and NADAC Pricing
By Ran Chen#Generics#FDA Approval#Market Access
Generics· June 27, 2026 · 17 min read
Generic Latuda Market: ANDA Exclusivity Settlements and NADAC Pricing
By Ran Chen#Generics#FDA Approval#Market Access
Generics· June 27, 2026 · 18 min read
Generic Restasis: Complex Ophthalmic Barriers and NADAC Pricing
By Ran Chen#Generics#FDA Approval#Ophthalmology
Generics· June 26, 2026 · 22 min read
Generic Revlimid REMS Launch: Lenalidomide ANDA Entry and NADAC Absence
By Ran Chen#Generics#Orange Book#Oncology
Generics· June 26, 2026 · 21 min read
Generic Tecfidera: Dimethyl Fumarate Patent Settlements and NADAC Erosion
By Ran Chen#Generics#Orange Book#PBM