Three Companies Relent to FTC Demands, Delist Patents from FDA’s Orange Book

FTC Entrance_iStock, FinkAvenue

Pictured: Federal Trade Commission entrance in Washington, D.C./iStock, FinkAvenue

In response to an FTC challenge last month, three companies have now put in requests to pull inhaler and injector patents from the FDA’s Orange Book database, according to multiple media outlets on Thursday. The move could potentially speed the entry of generics to the market. 

The FTC took issue with over 100 patents of the epinephrine injectors, asthma inhalers and other drugs that are “improperly or inaccurately listed” on the Orange Book. In November 2023, letters to 10 drugmakers including AbbVie, AstraZeneca, GlaxoSmithKline, Mylan, Boehringer Ingelheim, Impax Laboratories and Kaléo, as well as subsidiaries of Teva and GSK, were issued. 

At least three have now responded, Endpoints News reported Thursday. Impax delisted both of its patents for Adrenaclick, while Kaléo delisted eight patents covering Auvi-Q. Both products are epinephrine auto-injectors.  

GSK also withdrew three patents related to its asthma inhalers—three covering Arnuity Ellipta and another for its Advair HFA, Ventolin HFA and Flovent HFA products. The company is standing behind a  patent covering Arnuity Ellipta, contending that it is appropriate. 

The FTC challenge came after agency scrutiny of improper patent submissions in the Orange Book.  

“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 in a statement at the time, adding the Commission would work to protect Americans from “illegal business tactics” that hike the cost of drugs. 

Patent listing in the Orange Book comes with a perk for pharma companies. If a company files an infringement lawsuit, an Orange Book listing triggers an automatic 30-month stay of FDA approval. Delisting from the Orange Book doesn’t negate a patent or mean a company can’t still file an infringement lawsuit.  However, it removes the protective cushion for the generic reaching the market during the lawsuit. 

The FTC argued that some drug developers take advantage of the system, filing sham patents to delay generic competition entering the market.  

The FTC’s Orange Book action is part of the Biden Administration’s Inflation Reduction Act initiative, signed into law in 2022 and intended to reduce costs of prescription medications.  

The remaining patent challenges issued by the FTC have not yet been responded to by other companies. According to Endpoints, AstraZeneca, Boehringer Ingelheim and Teva are standing by their patents.  

“We are discussing next steps for the companies that ignored our warning letters and did not remove their patents,” an FTC spokesperson told FiercePharma

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.   

Back to news