The Food and Drug Administration has given tentative approval to Viatris and Kindeva Drug Delivery for their Symbicort generic (budesonide/formoterol fumarate dihydrate). The generic — which would be the first for Symbicort — is indicated to treat asthma or chronic obstructive pulmonary disease.
"I am very proud of this important regulatory milestone as it once again demonstrates our strong scientific and regulatory teams' continued success," said Rajiv Malik, Viatris president. “This only further enhances our confidence that through the Global Healthcare Gateway and partnerships, like this one with Kindeva, we will continue to build and commercially launch robust branded and complex generic portfolios."
The FDA provided tentative approval due to ongoing patent litigation. On March 2, the U.S. District Court for the Northern District of West Virginia found that the asserted claims of AstraZeneca's Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137, are not invalid for obviousness. Viatris and Kindeva said they disagreed with the district court decision. While the trial court decision prevents commercial launch at this time, the companies intend to file an appeal to continue vigorously defending their position that the patents are invalid.
The FDA's tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients,” said Viatris CEO Michael Goettler. “It also further demonstrates our deep commitment to continuing to leverage our scientific and regulatory expertise for a wide range of noncommunicable 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."
Viatris and Kindeva said that they are committed to bringing a generic Symbicort to market as soon as possible.
"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," said Aaron Mann, CEO of Kindeva Drug Delivery. "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, Calif. facility."
Viatris has not planned any revenue for 2021 from generic Symbicort, and the product's potential launch revenue was not included in the company's recently announced 2021 financial guidance.
Symbicort had a market value of $3.5 billion for the 12 months ending January 2021, according to IQVIA.