Published on Mar 24, 2025
Teva (TEVA), the drugmaker at the center of the Federal Trade Commission’s efforts to curb the improper listing of patents in the Food and Drug Administration’s Orange Book, has asked the FDA to delist five patents associated with its asthma inhaler, ProAir HFA, in response to a recent court order, according to the FDA’s patent and exclusivity database.
Multiple court rulings have concluded that the Teva patents are improperly listed because they claim components of the device rather than the underlying drug ingredient, albuterol sulfate.
The U.S. Court of Appeals denied Teva’s request for a stay of the delisting order and, on March 14, terminated the appeal, starting the countdown for Teva to ask the FDA to pull its patents from the Orange Book, which is a list of drug products and their patent protections. Teva may yet appeal this decision to the Supreme Court, as The Capitol Forum reported last week.
The delisting order emerged from a patent infringement case filed in 2023 by Teva against Amneal (AMRX), a drugmaker seeking to market a generic version of ProAir HFA. In response to Teva’s patent infringement claims, Amneal filed antitrust counterclaims arguing that the patents Teva was asserting were improperly listed. The FTC backed up Amneal in a March 2024 amicus brief and stated that listing sham patents in the Orange Book illegally delays generic competition.
The FTC’s decision to weigh in on Teva v. Amneal made the case center stage for the agency’s broader crusade against potentially improper Orange Book patent listings that cover device components rather than the drug ingredient—a violation of case law, in the FTC’s eyes.
In November 2023 and April 2024, the FTC sent out warning letters to brand-name drugmakers, including Teva, disputing hundreds of patent listings on drug-device products such as asthma inhalers, epinephrine injectors and weight-loss drugs. Many of those drugmakers refused to delist their disputed patents, instead opting to watch Teva’s battle play out in court, as The Capitol Forum previously reported.
The stakes of the FTC’s warning letters—and the outcome of Teva v. Amneal—are highest for drugmakers that, like Teva, have asserted their potentially improper patent listings against would-be generic challengers.
It’s worth noting that outside of the Orange Book, brand-name drugs can be protected by patents listed with the U.S. Patent and Trademark Office and drugmakers can choose to litigate those patents as well. However, if and when the patents are delisted from the Orange Book, Teva will lose its automatic Orange Book-based 30-month stay on generic competition, a feature of the system governing brand-generic patent litigation in the U.S.
Teva did not respond to a request for comment on the delisting of the five ProAir HFA patents. The company also did not respond to questions on whether it will soon delist other drug-device patents challenged by the FTC (the agency disputed patents on eight different inhalers made by Teva, including patents not at stake in Teva v. Amneal).
Amneal did not respond to a request for comment on its plans to launch a generic in light of the delisting request.
Additional delistings on asthma inhalers, GLP-1 drugs. The ripple effects of the Teva case might already be playing out across the pharmaceutical industry.
Boehringer Ingelheim, another drugmaker targeted in the FTC’s Orange Book crackdown, has asked the FDA to delist five patents that are the sole Orange Book listings covering its asthma inhalers Combivent Respimat and Spiriva Respimat. These patent listings also make up some, but not all, of the Orange Book patent protections on two other Boehringer Ingelheim inhalers, Striverdi Respimat and Stiolto Respimat
These patents (plus another that recently expired) were all disputed by the FTC. Boehringer Ingelheim has asserted the same patents against generic drugmaker Anovent Pharmaceuticals in several lawsuits.
According to a filing in a patent case against Anovent’s subsidiary Anobri, Boehringer Ingelheim requested removal of the patents on March 7—a few days after the appeals court denied Teva’s request for a rehearing of its case.
Boehringer Ingelheim did not respond to an immediate request for comment on why it asked the FDA to delist those patents and on whether it will be pulling other patents challenged by the FTC.
Novo Nordisk (NVO), maker of several blockbuster GLP-1 weight loss drugs, also appears to have delisted all the patents challenged by the FTC on the devices that deliver Ozempic (semaglutide), Victoza (liraglutide), and Saxenda (liraglutide).
To be sure, Ozempic will be covered by several remaining patents in the Orange Book, including patents on the underlying drug ingredient, if and when the delisting request is processed. The same goes for Saxenda and Victoza. Still, the removal of the FTC-challenged patents could significantly weaken patent protections on these products, which Novo Nordisk has defended against generic challengers.
Novo Nordisk declined to comment on the matter.
Several other companies still have not delisted FTC-challenged patents: Mylan Specialty (VTRS), GlaxoSmithKline (GSK), AstraZeneca (AZN), AbbVie (ABBV), Covis Pharmaceuticals, Novartis (NVS) and Amphastar (AMPH). These companies did not respond to immediate requests for comment.
