Global pharma major Lupin Limited on Tuesday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Prasugrel Tablets USP, 5 mg and 10 mg, a generic equivalent of Effient Tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc.
The product will be manufactured at Lupin’s facility in Goa, India.
Prasugrel Tablets USP, 5 mg and 10 mg, (RLD Effient) had estimated annual sales of USD 18 million in the U.S. (IQVIA MAT September 2022).
Prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). This medication helps to prevent other serious heart or blood vessel problems (such as heart attacks, strokes, blood clots in stents). It works by blocking platelets from sticking together and prevents them from forming harmful blood clots.
Lupin has a strong-hold in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.
Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7 percent of its revenue in research and development in FY22.
