FDA Orange Book Patent Information and Submission Requirements | Practical Law

FDA Orange Book Patent Information and Submission Requirements | Practical Law

A Practice Note discussing patent information for approved drug products listed in the Food and Drug Administration (FDA) publication Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). This Note outlines the Orange Book's role in the Hatch-Waxman Act's drug approval pathway for Abbreviated New Drug Applications (ANDA) and Section 505(b)(2) applications, focusing on the patent information it contains, accessing and reviewing Orange Book patent information, information submission requirements, and the mechanics of submitting patent information to pending and approved New Drug Applications (NDA) for inclusion in the Orange Book.

FDA Orange Book Patent Information and Submission Requirements

Practical Law Practice Note Overview w-033-9994 (Approx. 23 pages)

FDA Orange Book Patent Information and Submission Requirements

by Practical Law Intellectual Property & Technology
Maintained • USA (National/Federal)
A Practice Note discussing patent information for approved drug products listed in the Food and Drug Administration (FDA) publication Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). This Note outlines the Orange Book's role in the Hatch-Waxman Act's drug approval pathway for Abbreviated New Drug Applications (ANDA) and Section 505(b)(2) applications, focusing on the patent information it contains, accessing and reviewing Orange Book patent information, information submission requirements, and the mechanics of submitting patent information to pending and approved New Drug Applications (NDA) for inclusion in the Orange Book.