Lupin launches Tacrolimus Capsules USP

Lupin announced the launch of Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech received approval for its ANDA from the United States Food and Drug Administration (US FDA).

Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, are the generic equivalent of Prograf Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US, and are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in paediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants.

Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (RLD: Prograf) had an annual sales of approximately $303 million in the US (IQVIA MAT September 2020).