Alembic Pharma receives USFDA approval for gBrovanaAPLLTD - 605 Change: 4.85 (0.81 %)
News: Alembic Pharma has received USFDA final approval for its ANDA, co-developed in partnership with Orbicular Pharma for Arformoterol Tartrate Inhalation Solution (USRLD: Brovana of Sunovion Pharma). The drug is indicated for maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) and has an estimated market size of US$251 million (MAT Dec,21, IQVIA).
Views: Arformoterol, although in partnership with Orbicular Pharma, has large addressable market with increasing competition (seven players). Indian players like Cipla (market share of ~30%) and Lupin (market share of ~25%) have benefitted hugely by ramping up sales in FY22. Realizations from this approval will largely be dependent on Alembic’s ability to take market share amid likely price erosion with new competition. We expect Alembic Pharma’s US revenues to grow at CAGR of 8% to | 1942 crore over FY22-FY24E.