Lupin’s Alliance Partner Concord receives approval for Mycophenolic Acid Delayed Release Tablets

Lupin in alliance with Concord Biotech Limited (Concord) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, to market the generic equivalent of Myfortic® Delayed-Release Tablets, 180 mg and 360 mg, of Novartis Pharmaceuticals Corporation.

Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, are 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.

Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg (RLD: Myfortic®) had an annual sales of approximately USD 174 million in the U.S. (IQVIA MAT September 2019).