FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies.

In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its exclusivity policy for fixed combination drug products. If implemented, the guidance would provide five years of market exclusivity, rather than three years, to fixed-combination drug products that include both new and previously approved active moieties. The change will have significant effects on life cycle management strategies, corporate partnering activities, and the science around fixed-combination products, breathing new life into the value of some old drugs.

Statutory Five-Year Exclusivity Provision -

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), sponsors of certain drug products can receive periods of market exclusivity granted by FDA that are in addition to the patent protection the products might otherwise have. Market exclusivity is intended to encourage innovation by protecting the owners of new drug applications (NDAs) from competition for prescribed periods of time. During these periods of time, FDA is prevented from approving and, in some cases, receiving applications submitted under section 505(b)(2) of the FFDCA and abbreviated new drug applications (ANDAs) that refer to the approved drug substance.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Written by:

Published In:


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morgan Lewis | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.