Pharma major Lupin Limited (Lupin) announced today the launch of Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech Limited (Concord) received approval for its ANDA from the United States Food and Drug Administration (U.S. 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, Inc., and are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants.

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