AstraZeneca sues Mylan after securing fresh delivery patent on Symbicort

AstraZeneca has opened another front in its effort to protect its respiratory disease drug Symbicort from generic competition, securing a patent and immediately following up with a lawsuit against Mylan and Kindeva Drug Delivery.

Viatris, the result of the Mylan-Pfizer Upjohn combination, won tentative FDA approval for its generic version of AstraZeneca’s blockbuster asthma and chronic obstructive pulmonary disease drug Symbicort in March 2021. The FDA granted final approval to the generic, which is branded Breyna, earlier this year, but AstraZeneca has now sought to raise another legal barrier to the competitor. 

The barrier is built on 11,311,558, a patent issued by the U.S. office last week. The patent relates to the formulation of formoterol and budesonide, the active ingredients in Symbicort, with “HFA 227, PVP and PEG, preferably PVP K25 and PEG 1000” to treat respiratory diseases. The patent goes on to describe the preferred percentages of the various components in the finished product and include them in the claims.

Having secured the patient, AstraZeneca filed an ANDA action against Mylan and Kindeva in the District Court asserting patent infringement. The filing adds to the existing legal dispute between the companies.

Viatris targeted a 2022 launch for Breyna when it received full FDA approval in March while noting that the legal situation was still up in the air. Late last year, the U.S. Court of Appeals for the Federal Circuit reversed an infringement judgment against Viatris, sending the case back to a district court for further proceedings. A trial is scheduled for May.

Billions of dollars rest on the legal cases. Symbicort generated sales of $2.7 billion in 2021, down slightly on the prior year because of a contraction outside the U.S. but still enough to ensconce the drug toward the top of the list of AstraZeneca’s biggest products. Sales grew 4% in the U.S.