After seeing four of its patents for its Symbicort tossed aside, AstraZeneca has gained a key victory in defense of its blockbuster inhaler. A federal court in West Virginia upheld the company’s claim of infringement against Viatris and Kindeva Drug Delivery.
Judge John Preston Bailey ruled that the companies—who have already secured FDA approval for their generic version of the asthma and COPD treatment—infringed five claims against the ’558 patent, which protects Symbicort’s formulation of formoterol and budesonide.
With the win, AZ gains six more months of exclusivity for Symbicort, which generated (PDF) $2.7 billion in sales in 2021. The patent at issue is set to lapse in late July 2023.
Viatris earned full approval for its generic version, Breyna, early this year. Then on April 26, AZ secured its ’558 patent. A week later, the company filed its suit, which led to Thursday's decision.
Symbicort will celebrate its 17th year of exclusivity in 2023. It was approved for asthma in 2006 and for COPD in 2009.
In 2018, AZ initiated action against Viatris (then known as Mylan), claiming infringement of its patents. In 2020, drug delivery specialist Kindeva was added as a defendant. After legal proceedings, three of the patents were invalidated, joined by a fourth just last month.
In 2020, AZ launched its own, authorized generic version of the drug, which is cheaper and does not include the brand name on its label.
Drug-delivery devices such as inhalers have been notoriously hard for generics companies to launch thanks to complex regulatory and patent issues. In one high-profile example, companies seeking to rival GSK's Advair with generics faced a host of setbacks before their eventual launches.