FDA Moves Generic Dapagliflozin a Step Closer to US Sales

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The US Food and Drug Administration (FDA), on February 23, finalized its decision approving the therapeutic equivalence of a generic formulation of the SGLT2 inhibitor dapagliflozin made by Zydus Pharmaceuticals to the branded version, Farxiga, that is marketed by AstraZeneca.

The FDA added two different dose formulations of this generic dapagliflozin, 5 mg and 10 mg, to the agency’s list of Approved Drug Products With Therapeutic Equivalence Evaluations, a publication commonly known as the Orange Book. The agency’s action followed tentative approval of therapeutic equivalence that it gave to the two Zydus formulations in October 2020.

However, the Zydus formulations of dapagliflozin will likely not soon appear on the US market because in October 2021 the company failed in its bid in US District Court to invalidate the patent that AstraZeneca holds on dapagliflozin through 2025 based on a claim of “obviousness.” The court dismissed the Zydus claims and upheld the validity of the patent.

Dapagliflozin, as Farxiga, currently has FDA labeling for multiple indications: to improve glycemic control in adults with type 2 diabetes; to reduce the risk for hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors; to reduce the risk for hospitalization for heart failure in patients with heart failure with reduced ejection fraction; and to reduce the risk for sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk for progression.

Dapagliflozin is one of four agents from the sodium-glucose cotransporter 2 inhibitor class approved for US marketing. The other approved agents in the class are canagliflozin (Invokana, Janssen), empagliflozin (Jardiance, Boehringer Ingelheim), and ertugliflozin (Steglatro, Merck).

Mitchel L. Zoler is a reporter with Medscape and MDedge, based in the Philadelphia region. @mitchelzoler

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