Generics· August 27, 2026 · 17 min read
FDA's Cabazitaxel 314.161 Notice: ANDAs to Dead 10 mg/mL NDA, Not Jevtana Kit
By Ran Chen#Generics#Orange Book#505(b)(2)
Topic
Generics
ANDA strategy, Paragraph IV risk, therapeutic equivalence, supply concentration, and price erosion.
Generics· August 25, 2026 · 18 min read
Dasynoc's CRL Is a Facility Letter: Nine AB Generics and Phyrago Occupy Access
By Ran Chen#Generics#505(b)(2)#Orange Book
Generics· August 23, 2026 · 17 min read
FDA's August 2026 TE Final: 505(b)(2) Requests and Orange Book Blanks
By Ran Chen#Orange Book#505(b)(2)#FDA Approval
Generics· August 22, 2026 · 17 min read
FDA's August 2026 PSG Batch: Development Clock vs Orange Book Exclusivity
By Ran Chen#Generics#Orange Book#FDA
Generics· August 21, 2026 · 17 min read
The Estradiol Patch Shortage: Reading FDA's Database Against ASHP Bulletins
By Ran Chen#Supply Chain#Generics#Orange Book
Generics· August 20, 2026 · 17 min read
Xcopri's First Generic Settlement: Reading the Cenobamate Patent Fence
By Ran Chen#Generics#Orange Book#Generic Entry
Policy· August 19, 2026 · 18 min read
CMS Bona Fide Marketing Rule: What the D.C. Circuit Teva Ruling Actually Revived
By Ran Chen#Policy#IRA Negotiation#Medicare Part D
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
Pricing & Access· August 16, 2026 · 18 min read
Hepatitis C Treatment Access in 2026: Generic Economics, PA, and Sobriety
Manufacturing· July 26, 2026 · 17 min read