Lupin gets US FDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, to market a generic equivalent of Doryx Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC Delayed Release Tablets, 60 mg and 120 mg, of Mayne Pharma International.

 This product will be manufactured at Lupin’s Pithampur facility in India.

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of $9 million in the US. (IQVIA MAT June 2023).