Symbicort, an inhalation aerosol is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). The drug had U.S. branded sales of $3.5 billion for the 12 months ended January 2021, according to IQVIA.
According to a news release, the FDA granted tentative approval of the budesonide/formoterol fumarate dihydrate products (generic Symbicort) based on an abbreviated new drug application (ANDA).
Tentative approval from the FDA is a result of ongoing patent litigation after AstraZeneca’s claims over its Symbicort patents. Viatris and Kindeva say they disagree with a West Virginia district court decision that those claims are not invalid for obviousness, but that decision currently prevents a commercial launch.
The companies plan to file an appeal to defend their position that the patents are invalid so they can bring the generic Symbicort to market as soon as possible.
Viatris has not planned any 2021 revenues from generic Symbicort and the potential launch revenue was not included in its recent 2021 guidance.
“The FDA’s tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients,” Viatris CEO Michael Goettler said in the release. “It also further demonstrates our deep commitment to continuing to leverage our scientific and regulatory expertise for a wide range of non-communicable and infectious diseases. Our success with this partnership and approval underscores how Viatris intends to execute and optimize our Global Healthcare Gateway as a Partner of Choice for companies such as Kindeva to expand access to medicines for patients worldwide.”
“This FDA tentative approval reflects the strength of the partnership between Viatris and Kindeva, and further demonstrates Kindeva’s industry-leading capabilities in formulation, development, and manufacturing of complex combination products,” added Kindeva CEO Aaron Mann. “Once final FDA approval is achieved, Kindeva looks forward to providing Viatris with reliable, quality supply from our state-of-the-art commercial filling and packaging lines in our Northridge, California facility.”