AstraZeneca sues Mylan for asthma drug, again

The same day AstraZeneca secured a patent for its respiratory disease drug Symbicort, the drugmaker filed a lawsuit against Mylan Pharmaceuticals and Kindeva Drug Delivery.

Viatris, a healthcare company developed out of a collaboration between Mylan and Pfizer’s Upjohn Business, won approval for its abbreviated new drug application (ANDA) for Breyna, the generic version of AstraZeneca’s drug, back in March 2021. Breyna is an inhaler approved for patients with asthma or chronic obstructive pulmonary disease. 

AstraZeneca’s dispute is based on patent number 11,311,558, issued by the U.S. Patent Office

The patent gives AstraZeneca the rights to its concoction 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 also has information on how much of each component AstraZeneca will include in the finished product, which it includes in its suit against Mylan.

The ANDA action that AstraZeneca has filed against Mylan and Kindeva adds to the legal troubles brewing between the companies. In March 2021, a U.S. court ruled in favor of AstraZeneca’s patent for Symbicort and said the patent was valid. That dispute started in October 2018, when AstraZeneca filed a Hatch-Waxman Act suit accusing Mylan of infringing three patents for Symbicort in the U.S.