Competitive Generic Therapy: A New Patient-Centric FDA Pathway

Regulatory Spotlight: Competitive Generic Therapy

In light of the ongoing public and political concern over drug pricing, the U.S. Food and Drug Administration (FDA) has developed a number of patient-centric initiatives aimed at reducing drug prices, preventing sudden price increases and protecting vulnerable patient populations. A number of these initiatives involve championing the development of generics, which has become an essential pillar in the agency’s mission to serve public health.

This summer bore the first fruits of one of the FDA’s latest initiatives promoting generics, as Apotex’s Abbreviated New Drug Application (ANDA) 211067 became the first generic drug to obtain approval under the agency’s new Competitive Generic Therapy (CGT) designation.1

Competitive Generic Therapy

The CGT pathway was introduced in an amendment to the FDA Reauthorization Act of 2017, following Congressional oversight hearings into a series of steep price increases for older drugs like Epipen, Daraprim and Nitropress that concluded that a competitive marketplace serves patient interests by reducing drug prices. The CGT pathway was designed to incentivize the development of generics for drugs for which there is effectively no market competition, particularly in the cases of drugs for smaller patient populations less likely to attract investment.2

Eligibility for the CGT designation is based on a determination by the FDA that there is “inadequate generic competition” for a given drug, defined as there being no more than one approved drug in the active section of the Orange Book, regardless of whether it is the original NDA-approved reference listed drug (RLD) or a generic.2

The CGT designation confers several advantages to the sponsor company, including cross-disciplinary FDA assistance provided to the sponsor during the application process and throughout development, expedited review of their ANDA and eligibility for a 180-day period of marketing exclusivity.

The CGT designation essentially extends the six-month exclusivity typically granted to the first approved generic for a given drug to a new generic version of any drug for which there is no more than one actively commercialized product.

The first CGT-designated drug is potassium chloride oral solution (20 and 40 MEQ/15 mL) for the prevention and treatment of hypokalemia in patients on ongoing diuretic therapy. The patient population targeted by this drug is not large, but it will be better served by the introduction of competition into the market. The generic drug was approved in its first cycle of review, which further underscores the advantages of the deeper agency engagement and the expedited process.1

The CGT pathway was designed to incentivize the development of generics for drugs for which there is effectively no market competition, particularly in the cases of drugs for smaller patient populations less likely to attract investment.

A New Paradigm

FDA Commissioner Scott Gottlieb, M.D., argued that the approval validates the agency’s patient-centric pro-generics approach: “This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”2

Chip Davis, the President and CEO of the Association for Accessible Medicines, a trade group representing generics manufacturers and distributors, praised the CGT pathway, hailing it as “a better long-term sustainable solution than considering bringing in drugs from foreign markets.”3


  1. Koblitz, Sara W., Karst, Kurt R. “It Feels Like the First Time: FDA’s First Competitive Generic Therapy Approval.” FDA Law Blog. 9 Aug. 2018. Web.
  2. Karst, Kurt R. “Schrader Amendment to House UFA Package Creates New ‘Competitive Generic Therapy’ Pathway and 180-Day Exclusivity.” FDA Law Blog. 19 May 2017. Web.
  3. AAM Statement in Response to FDA’s Competitive Generic Therapy (CGT) Designation. Association for Accessible Medicines. 16 Jul. 2018. Web.

David Alvaro, Ph.D.

David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That's Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.