Alembic Pharmaceuticals, an Indian pharma company, announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) to launch a generic Opsumit (macitentan), according to Ultra News.
Opsumit, including its generic versions, is the bigger seller in the market with estimated annual sales of nearly $800 million.
Most of the drugs’ generic forms developed and sold by Indian companies in the market are estimated to have annual sales between $100 and $200 million.
Actelion Pharmaceuticals US, Inc., develops Opsumit 10 mg tablets. The FDA approved the brand Opsumit in October 2013 for the treatment of pulmonary arterial hypertension (PAH), a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.
Alembic said, “Macitentan is therapeutically equivalent to Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc.”
Macitentan belongs to a class of drugs called endothelin receptor antagonists (ERAs). It treats PAH to delay disease progression.
Untreated PAH could result in death. Severe PAH requires the initiation of intravenous (IV) or subcutaneous prostanoids.
Opsumit has been found to reduce hospitalization, as well as lower chances of disease progression.
Macitentan is also indicated for other medical conditions and Actelion continues to hold exclusive patent rights over the use of the drug for those conditions.
Alembic said it has received 22 approvals – 15 final approvals and 7 tentative approvals – for Abbreviated New Drug Applications (ANDA) or generic drugs.
The FDA has so far granted 161 ANDA approvals – 138 final approvals and 23 tentative approvals.
Established in 1907, Alembic manufactures and sells generic drugs all over the world. Headquartered in Vadodara, Gujarat, Alembic is one of the top Indian multinational pharmaceutical companies involved in manufacturing quality generic drugs.
