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News: Cipla has received final approval for its ANDA for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg (generic of BMS’s Revlimid) from USFDA. Lenalidomide is an immunomodulatory prescription drug, which is indicated for several hematological malignancies.
View: Revlimid capsule in strengths of 5 mg, 10 mg, 15 mg and 25 mg had CY21 annual sales of US$7825 million. Natco received approval for these strengths in March,2022. With loss of exclusivity in September,2022, many players are ready to enter the US market in this wave of launch. We have factored in the NPV of Rs 33 for gRevlimid opportunity for Cipla and with likely more complex launches like generic Advair, generic Abraxane and peptide assets we expect US business to grow at CAGR of 11% to Rs 5430 crore over FY22-24E.
Impact: Positive.