Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration to launch a generic form of blood pressure tablet Opsumit.
The tablet, including generic forms such as macitentan, is one of the bigger sellers in the market with estimated annual sales of $797 mn. Most of the generic drugs sold by Indian companies in the market tend to have annual sales in the range of $100-200 mn.
Macitentan is therapeutically equivalent to Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc, the Indian drugmaker said.
They belong to a class of endothelin receptor antagonists (ERA) indicated for the treatment of pulmonary arterial hypertension to delay disease progression.
Pulmonary hypertension or high blood pressure can result in death, or require initiation of intravenous (IV) or subcutaneous prostanoids, and lead to lower stamina.
Macitentan tablets have been found to reduce hospitalization, besides lowering chances of disease progression.
While Macitentan also has other uses, Actelion Pharma continues to hold exclusive rights over the use of the drug for those diseases, and this product cannot be used to treat such indications.
With this, Alembic said has received 22 approvals (15 final approvals and 7 tentative approvals) for abbreviated new drug applications or generic products.
It has so far received a total of 161 ANDA approvals (138 final approvals and 23 tentative approvals) from USFDA.
The company, set up more than 100 years ago, manufactures and markets generic pharmaceutical products all over the world and is one of the leaders in branded generics in India.