Pharma Major Lupin said it got the approval of the US Food and Drug Administration to launch a generic version of Bayer’s oral contraceptive Safyral.
The branded version has annual sales of around $23 mln in the US.
Lupin’s product will be called Tydemy.
The combination is indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception, Lupin said.
The combination involves Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg.
Lupin is the 6th largest generics pharmaceutical company by revenue.