GlaxoSmithKline & other drugmakers delist FDA patents, after FTC 'Big Pharma' scrutiny
After the Federal Trade Commission sent warning letters to 10 drugmakers over 100 “improper” patents, 3 chose to delist their patents from the FDA’s registry, potentially accelerating the approval of generic versions.
In response to challenges from the Federal Trade Commission, at least three pharmaceutical companies have asked to remove their patents from the Food and Drug Administration’s Orange Book, which records patents on branded drugs and serves as a reference for generic manufacturers. The move by drugmakers could essentially accelerate the approval of generic versions of the drugs.
In November, the FTC sent warning letters to 10 medical device companies and drugmakers disputing the accuracy or relevance of more than 100 patents found in the book. Many of the patents at issue were for asthma inhalers, epinephrine autoinjectors and other drug products that may lead to delayed generic competition.
“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” FTC Chair Lina M. Khan said. “The FTC’s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens. We will continue to use all our tools to protect Americans from illegal business tactics that are hiking the cost of drugs and drug products.”
In response, Glaxo Smith Kline, Impax Laboratories and Kaléo have agreed to delist patents. GSK will remove three patents covering its Arnuity Ellipta inhaler and another covering its Advair HFA, Ventolin HFA and Flovent HFA products. Although they no longer will be in the Orange Book, GSK said its patents are still “valid and enforceable.” Amneal’s Impax Laboratories also withdrew two patents on its epinephrine autoinjection AdrenaClick, a $50 million a year epinephrine product. The eight patents that the FTC targeted for Kaleo’s epinephrine injection Auvi-Q have also been delisted in the FDA’s database.
Delisting from the Orange Book doesn’t negate a patent, however, it removes the protective cushion for the generic reaching the market during the lawsuit. However, delisting means generic rivals won’t be subject to a 30-month stay, which is required when an Orange Book patent is challenged in court.
Letters were sent to 10 companies, including Teva Branded Pharmaceutical; Norton Limited; Mylan Specialty; Impax Labs; Glaxo Smith Kline; Glaxo Group; Boehringer Ingelheim; AstraZeneca, Kaleo and Abbvie.
“The delays in generics coming to the market that can be caused by these illegal listings raise prices on millions of Americans who rely on these medicines,” FTC spokesperson Douglas Farrar told Endpoints. “We are discussing next steps for the companies that ignored our warning letter.”
Related: GSK settles first Zantac cancer lawsuit (Pfizer and Sanofi settled previously)
Disputing patents in the Orange Book is one of several measures that the Biden administration has adopted in an attempt to control drug costs. The FTC has increased its scrutiny over Big Pharma’s acquisitions, leading to delays, asset divestitures and deal terminations. Under the Inflation Reduction Act, Medicare is imposing rebates against 48 drugs whose prices grew faster than inflation. In the coming years, the U.S. government also plans to directly negotiate drug prices for the first time.