FDA Grants Tentative Approval to Generic Version of Symbicort

Viatris Inc. and Kindeva Drug Delivery L.P. have announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort  based on an Abbreviated New Drug Application (ANDA). Symbicort is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

"The FDA's tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients,” commented 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 President Rajiv Malik added, "I am very proud of this important regulatory milestone as it once again demonstrates our strong scientific and regulatory teams' continued success. 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."

Complications in Court

The FDA provided tentative approval at this time due to ongoing patent litigation. On March 2, 2021, 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 disagree 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. Viatris and Kindeva 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, California 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.