Viatris clears regulatory hurdle to launch of generic Symbicort, but IP barriers remain in place

The FDA has granted tentative approval of the first generic version of AstraZeneca’s blockbuster drug Symbicort. Viatris and Kindeva Drug Delivery secured the tentative approval but still face a patent barrier to launch, with AstraZeneca prevailing in a court case last week. 

U.S. sales of Symbicort grew 23% last year to top $1 billion. Growth in the U.S., where an authorized generic came to market in January 2020, enabled AstraZeneca to increase global sales by 9% despite off-patent competitors putting Symbicort under pressure in some territories. Viatris, the result of the Mylan-Pfizer Upjohn combination, is now gearing up to try to eat away at U.S. sales of Symbicort.

The tentative FDA approval covers a budesonide/formoterol fumarate dihydrate formulation created by Viatris and Kindeva, a specialist in inhaled drug delivery, and moves the partners a step closer to introducing an inhaler product to challenge AstraZeneca.

However, the launch of the inhaled treatment for asthma and chronic obstructive pulmonary disease is subject to the elimination of intellectual property barriers. Mylan, now Viatris, has been involved in a patent dispute with AstraZeneca that briefly dragged in 3M and now involves Kindeva. Last week, the U.S. District Court for the Northern District of West Virginia ruled in favor of AstraZeneca.

Mylan and Kindeva sought to show claims in three AstraZeneca patents to be invalid. The court ruled against the partners, but the row is set to continue. Viatris and Kindeva said they disagree with the decision and plan to “file an appeal to continue vigorously defending their position that the patents are invalid.”

For now, the patents are blocking Viatris’ path to market, leading the FDA to only grant its generic a tentative approval. Viatris has not included revenues from generic Symbicort in its 2021 guidance. When the product does come to market, Kindeva will support the launch using the commercial filling and packaging lines at its plant in Northridge, California.