Vilanterol Trifenatate

Pictured: Facade of a U.S. courthouse/iStock, PierreDesrosiers A New Jersey federal court on Monday ruled against Teva Pharmaceuticals, finding that five key patents for its inhaler product ProAir HFA (albuterol sulfate) are “improperly listed” on the FDA’s Orange Book. District Judge Stanley Chesler agreed with the plaintiffs—Amneal Pharmaceuticals, with the backing of the FTC—that Teva’s patents only apply to the inhaler device of ProAir HFA and not to its albuterol sulfate drug formulation. The judge ruled that Teva’s inhaler patents do not claim a “finished dosage form” of albuterol, allowing Amneal to develop a generic version of the drug. “It is undisputed that no claim in any of the Inhaler Patents discloses albuterol sulfate,” Chesler wrote in his decision, adding that Teva must either “correct or delete” its patent listings in the FDA’s Orange Book to reflect the court’s judgement. Amneal in July 2023 submitted an Abbreviated New Drug Application (ANDA) for a generic version of ProAir HFA, though its filing specifically focused on inhalable albuterol sulfate. Teva in 2023 sued Amneal, claiming that the ANDA infringed on its patent protection for its drug-device combination product. Amneal filed a countersuit soon after claiming that Teva’s patents should not have been listed on the Orange Book in the first place. Teva’s lawsuit focuses on five key patents, dubbed the ‘712, ‘289, ‘587, ‘808 and ‘889 patents. Together, these patents protect aspects of Teva’s inhaler device and its metered dose system. However, in its suit, the pharma sought to expand this coverage to also include the albuterol formulation that the inhaler delivers. In his opinion, Chesler agreed with Teva that the term “drug” has a “broad scope” and could include devices or other components “intended for use for the treatment of disease.” However, the Orange Book’s listing statute modifies this definition with the restrictive phrase “for which the applicant submitted the application,” which Chesler argues nullifies Teva’s argument. “The fact that the statutory definition of ‘drug’ expressly includes devices for treating disease, and their components, does not nullify the restrictive action of the modifying phrase, ‘for which the applicant submitted the application,’” Chesler wrote. Monday’s ruling comes as the FTC is ramping up its scrutiny of “junk” patents listed on the FDA’s Orange Book. The antitrust watchdog launched its initial salvo in November 2023, challenging more than 100 patents by companies including AbbVie, GSK and Teva. The FTC’s opening campaign included a wide range of pharmaceutical products, including autoinjectors and inhalers. In April 2024, the FTC sent a warning letter to Novo Nordisk calling into question the patent of its blockbuster diabetes drug Ozempic (semaglutide). The federal agency also wrote to GSK to raise concerns about its asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Pictured: Entrance to the FTC's office in Washington, DC/iStock, hapabapa The U.S. Federal Trade Commission on Tuesday sent warning letters to 10 pharmaceutical companies, challenging patents for several drugs including Novo Nordisk’s blockbuster diabetes treatment Ozempic (semaglutide) and GSK’s asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate. “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a statement. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” Khan added. In addition to Ozempic and Trelegy Ellipta, the FTC’s latest round of patent challenges also targets Novo’s Saxenda (liraglutide) and Victoza (liraglutide)—both indicated for type 2 diabetes—and Novartis’ inhaler products Seebri Breezhaler (glycopyrronium bromide) and Utibron Neohaler (indacaterol and glycopyrrolate), approved for chronic obstructive pulmonary disease. The pharma companies now have 30 days to either withdraw or amend their disputed listings, or confirm “under penalty or perjury” that these patents indeed comply with the statutory and regulatory requirements. A GSK spokesperson in a statement to Endpoints News said that the company is reviewing the FTC’s letter. GSK takes “the FTC’s views seriously; however, we will also do our own analysis as the law requires. Once complete, we will respond to the FDA and FTC.” Meanwhile, a Boehringer Ingelheim spokesperson said that the pharma “has never wrongfully submitted patents for listing in the Orange Book.” Tuesday’s warnings follow an initial salvo in November 2023, when the FTC challenged more than 100 patents by 10 pharma companies including AbbVie, AstraZeneca and subsidiaries of GSK and Teva Pharmaceuticals. At the time, the antitrust watchdog targeted a wide range of pharmaceutical products, including inhaler devices, multidose bottles and epinephrine autoinjectors. Aside from the FTC, members of Congress have also started targeting the high cost of medication in the U.S., paying particular attention to Ozempic. Last week, Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, launched a probe into the ‘outrageously high prices’ of Ozempic, as well as its sister weight-loss therapy Wegovy (semaglutide). Sanders in a letter to Novo CEO Lars Fruergaard Jørgensen asked for additional information regarding Ozempic and Wegovy, including revenue, prices paid by public and private payers, R&D spending and the pharma’s tactics to extend their exclusivity. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.