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Tuesday, June 25 • 8:00am - 9:15am
#216: Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-590-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA’s Orange Book and other information resources are essential to potential applicants in developing their generic submissions. This session will provide an overview of these resources and the different information that each contains.

Learning Objectives

Describe the content of FDA’s Orange Book; Identify and understand drug product, patent, exclusivity, and therapeutic equivalence information in the Orange Book; Explain FDA’s process for making exclusivity determinations. Describe the process to qualify for Paragraph IV and Competitive Generic Therapy 180-day exclusivities as well as events which may result in exclusivity forfeiture. Understand which applicants are blocked by these exclusivities and triggering events.


Kendra Stewart, PharmD, RPh


Orange Book Overview
Kendra Stewart, PharmD, RPh

Identifying the Reference Listed Drug for ANDA Submissions
Martha Nguyen, JD

Understanding Exclusivities for ANDAs: 180-Day Exclusivity and Competitive Generic Therapy Exclusivity
Martin Shimer

avatar for Martha Nguyen

Martha Nguyen

Director, Division of Policy Development, OGD, CDER, FDA
Martha Nguyen is the Director of the Division of Policy Development in FDA CDER's Office of Generic Drugs, where she provides strategic leadership and direction on broad policy issues affecting generic drugs and oversees the development and clearance of regulations, guidance documents... Read More →
avatar for Martin Shimer

Martin Shimer

Deputy Director, Division of Legal and Regulatory Support, FDA
Captain Martin Shimer is the Deputy Director of the Division of Legal and Regulatory Support within the Office of Generic Drugs Policy (OGDP) at the Food and Drug Administration (FDA). He was commissioned as an officer in the US Public Health Service in July 2000 and joined the Office... Read More →
avatar for Kendra Stewart

Kendra Stewart

Supervisor, Orange Book Staff, Office of Generic Drug Policy, CDER, FDA
Captain Kendra Stewart is the Supervisor of the Orange Book Staff within the Office of Generic Drugs Policy (OGDP) at the Food and Drug Administration (FDA). She began her career in 2001 as a pharmacist for the Veterans Affairs Hospital. In 2003, she was commissioned as a Lieutenant... Read More →

Tuesday June 25, 2019 8:00am - 9:15am PDT
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session
  • Featured Topics Generics,Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session