News: Sun Pharma has received USFDA final approval for its ANDA Amphotericin B Liposome for injection,50 mg/vial single-dose vial (generic for AmBisome). Sun Pharma has been granted competitive generic therapy (CGT) designation by USFDA and is eligible for 180 days of CGT exclusivity for the product. Market size for AmBisome Liposome for Injection, 50 mg/vial is ~ US$136 million (MAT October 2021, IQVIA Health).
View: CGT exclusivity provides Sun with an opportunity to gain market share in this drug with limited competition. US contributed 30% (US ex Taro & Specialty: 8%) of total sales in FY21. This approval is likely to contribute in US growth, which we estimate to grow at CAGR of 9.5% in FY21-23E