FDA in Brief: FDA works to encourage and optimize drug competition with transparency

For Immediate Release: Dec. 15, 2017

Media Inquiries

"To continue to increase competition in the market for prescription drugs by facilitating the entry of lower-cost generic drugs, it’s important that we provide tools and resources to help companies to identify products on the market that lack competition, like our list of branded prescription drugs that are off-patent and off-exclusivity for which the agency has not approved a generic. Today we’ve made key changes to that list, including presenting the information more clearly by drug product instead of by active ingredient so companies can more easily identify products for potential development where competition is needed,” said FDA Commissioner Scott Gottlieb, M.D. “Coupled with this effort, we’re announcing today our intention to work with the U.S. Pharmacopeial Convention to maximize the utility of this list by asking USP to develop or modernize compendial standards to assist generic firms in copying many of the off-patent drug products on this list and to continue to provide useful, clear information to the generic drug industry to help encourage development of important generic medicines and increase access for patients."

Today, the U.S. Food and Drug Administration published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.” The list includes approved drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved a generic drug application (known as an abbreviated new drug application or ANDA) referencing that product. The agency modified the methodology it used to compile the first edition of the list (published June 2017) so that the list is now organized by drug product, not active ingredient. The list now also displays dosage forms for all drug products listed, to better clarify the information presented. The updated list also includes additional products not identified in the previous version of the list that have either recently lost exclusivity, or were otherwise not incorporated into the original list.

The agency maintains this list to improve transparency and encourage the development and submission of generic drug applications in markets with little competition. The agency will continue to refine and periodically update the list to identify drug products where increased competition has the potential to provide significant benefit to patients.

The FDA also intends to work with the U.S. Pharmacopeial Convention (USP) to maximize the utility of this list. The FDA-USP relationship is longstanding, and since 2010, the FDA has actively collaborated with USP in support of modernizing scientific standards for drug product development. The FDA intends to further this successful collaboration by working with USP to consider modernizing standards for the drug products on this list to continue to advance the development of generic medicines. Under this plan, the USP may use this list as a reference for determining drug products for which USP should consider developing or updating standards that generic firms use to guide the creation of copies of branded, reference drugs. These USP standards have long been used by generic firms as a way to guide their drug development processes. The agency will provide more details on this collaboration in the near future.

As noted in our June 2017 announcement, the FDA intends to expedite the review of any generic drug application for a product on this list to ensure that they come to market as expeditiously as possible. The agency will unveil additional aspects of the Drug Competition Action Plan in the months ahead.

Complementing this effort is the recently implemented policy change to include patent submission dates in updates to the Orange Book. This change allows the public to find patent submission dates easily through the Orange Book website, where previously there was no way to publicly find such information without contacting the agency. The agency started collecting patent submission date data in 2013, so approximately 4,000 patent submission date records are available to date.This is a critical step for transparency and complements the FDA’s other policy reforms and organizational improvements made in the Office of Generic Drugs.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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