The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Opsumit tablets, 10 mg, of Actelion Pharmaceuticals US, Inc. (Actelion). Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression.

Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Macitentan tablets also reduced hospitalization for PAH. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

According to IQVIA data, Macitentan tablets, 10 mg have an estimated market size of $797 million for twelve months ending December 2021. Alembic Pharmaceuticals has received year to date (YTD) 22 approvals (15 final approvals and 7 tentative approvals) and a cumulative total of 161 ANDA approvals (138 final approvals and 23 tentative approvals) from the US-based drug regulator, USFDA.

On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.

Shares of Alembic Pharmaceuticals lost 0.18% to Rs 731.80 on BSE. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.