The said drug is therapeutically equivalent to the reference listed drug product (RLD), Tibsovo Tablets of Servier Pharmaceuticals LLC.
Ivosidenib is a targeted therapy medication designed to treat specific cancers. It is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with newly diagnosed acute myeloid leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, adult patients with relapsed or refractory AML and adult patients with Locally Advanced or Metastatic Cholangiocarcinoma who have been previously treated.
According to IQVIA, Ivosidenib Tablets, 250 mg have an estimated market size of $114 million for twelve months ending March 2024
Alembic has a cumulative total of 207 ANDA approvals (179 final approvals and 28 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23.