The 505(b)(2) Pathway: Patent Certifications, Exclusivity, and Choosing Between an NDA and an ANDA

About the Course

Introduction

This CLE webinar will guide patent counsel on the strategic, regulatory, and litigation considerations surrounding FDA 505(b)(2) applications. The panel will address patent issues in the initial drug development records, patent certification and Orange Book strategy, and exclusivities, among other things.

Description

Section 505(b)(2) of the federal Food, Drug, and Cosmetic Act creates a hybrid approval route that is between a new drug application and an abbreviated application for a generic. An applicant submits a new drug application but relies in part on the FDA's prior findings of safety and effectiveness for a drug it does not own, supplementing that reliance with its own data or with published literature. The pathway has become the preferred option for reformulations, fixed-dose combinations, and repurposed molecules. The consequences for patent certification and exclusivity differ from those attaching to an abbreviated new drug application.

The FDA announced in August 2026 new draft guidance entitled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This guidance is to assist applicants in determining which abbreviated approval pathway under the federal Food, Drug, and Cosmetic Act is appropriate for the submission of a marketing application to the FDA. The 2026 guidance revises the 2019 guidance titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application."

Listen as our authoritative panel of patent attorneys examines the strategic, regulatory, and litigation considerations surrounding FDA 505(b)(2) applications. The panel will discuss whether a 505(b)(2) or ANDA pathway is most appropriate as well as implications of the FDA's recent guidance. The panel will also examine Orange Book and patent certification strategies and the litigation challenges that arise before and after approval. The panel will address FDA exclusivities and will offer best practices for navigating the 505(b)(2) pathway.

Credit Information

This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Live Online

On Demand

Date + Time

event
Thursday, October 8, 2026
schedule
1:00 PM ET/10:00 AM PT

I. Statutory framework and selecting a pathway

A. When to use (b)(2) versus ANDA; strategic considerations to avoid patents via (b)(2) route instead of ANDA route

B. The Aug. 2026 new FDA draft guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determining-whether-submit-anda-or-505b2-application-0

II. Development and application issues

A. Patent issues in the initial drug development records and how such records can come back to haunt you later in patent litigation

B. Similarities to the ANDA

III. Patent certification and Orange Book strategy

IV. Litigation Issues

A. Conducting (b)(2) type patent litigation, accelerating cases to align with potential PDUFA approval timelines; antitrust issues post-tentative approval

B. Patent litigation strategy to avoid the RLD patents and how such statements can be harmful when the (b)(2) is approved, patents are listed, and later litigated against ANDA sponsors

V. FDA issues and other exclusivity

A. FDA exclusivities available? NCE or three-year market, or seven-year Orphan Drug. Related patent strategies for longer living exclusivities.

B. Can one obtain "interchangeability" status for a (b)(2) application and treat it like an ANDA?

VI. Best practices

The panel will review these and other key issues:

What are the product characteristics that make an ANDA unavailable and require a 505(b)(2) application?
What Orange Book patent certifications and paragraph IV notice letters are required for a 505(b)(2) filing?
What is the litigation exposure under 35 U.S.C. § 271(e)(2) and the 30-month stay?