Lupin gets FDA OK for generic Myfortic, launches generic Hectorol

Lupin, in alliance with Concord Biotech has received approval from the Food and Drug Administration for mycophenolic acid delayed-release tablets, in dosage strengths of 180 mg and 360 mg.

The product is the generic of Novartis’ Myfortic delayed-release tablets, 180 mg and 360 mg.

It is indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant; use in combination with cyclosporine and corticosteroids.

The product had a market value of approximately $174 million, according to IQVIA September 2019 data.

Lupin also is debuting doxercalciferol injection, in 4 mcg/2 mL (2 mcg/mL) multi-dose vials, having received approval from the FDA earlier.

Lupin’s product is the generic of Sanofi Genzyme’s Hectorol injection, 4 mcg/2 mL (2 mcg/mL) multi-dose vials. It is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.

The product had a market value of approximately $132 million, according to IQVIA October 2019 data.