AstraZeneca breathes sigh of relief as court blocks US Symbicort generic

A US court has upheld AstraZeneca’s patents on its respiratory drug Symbicort, blocking cheaper competition for the ageing blockbuster.

The US District Court for the Northern District of West Virginia has decided in favour of AZ in litigation against Mylan Pharmaceuticals and Kindeva, the company said in a statement.

Mylan, which is now part of Viatris following a merger with Pfizer’s Upjohn unit late last year, is planning to appeal.

The court ruled that AZ’s asserted claims in three of its patents protecting Symbicort, which is the mainstay of AZ’s respiratory diseases business unit with sales exceeding $2.7bn, are not invalid.

More than $1 billion of those sales are based in the US, where sales grew 23% in the last year, with a recently-launched authorised generic from AZ’s collaborator Prasco helping to maintain market share.

The court case stems from October 2018, when AstraZeneca began litigation against Mylan and subsequently against 3M Company (3M) asserting infringement of various US patents covering Symbicort.

In July 2020, Kindeva was added as a defendant in the action. 3M was voluntarily dismissed from the case.

In September last year Mylan and Kindeva argued in the trial that each asserted patent claim is invalid under US patent laws.

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009.

A further approval in 2017 in childhood asthma has helped the drug to build sales in the US.

AZ has also tried to maintain interest in Symbicort by combining it with a sensor and app provided by Propeller Health that helps build a care plan for patients and generates insights into triggers and symptoms.

Symbicort (budesonide+formoterol) is a combination formulation containing budesonide, an inhaled corticosteroid that treats underlying inflammation, and formoterol, a long-acting beta2-agonist bronchodilator with a fast action, in a single inhaler.

A Viatris spokesperson said: "Viatris obviously disagrees with the district court decision and intends to file an appeal to continue vigorously to defend its position that the patents are invalid."