Articles tagged with “orange-book”

Orange Book RLD, Reference Standard and TE Code Crosswalk

A 2026 reference for ANDA teams: distinguish Orange Book RLD and reference standard roles, preserve AB-number TE groups, reproduce a 48,865-row census and implement versioned reference-product joins.

22 min read

10/22/2026

orange book reference listed drug reference standard therapeutic equivalence te codes anda openfda pharma data architecture

Drug Patent Expirations 2027-2030: Market Entry Calendar

A dated calendar of drug patent, exclusivity, and settlement-based market-entry events for 2027-2030, with a reproducible method and September 2026 sourcing.

25 min read

9/5/2026

drug patent expirations patent cliff 2027 biosimilar market entry generic drug launch calendar pharma patent cliff 2030 biologics exclusivity orange book purple book loss of exclusivity pharmaceutical patents