Alembic Pharmaceuticals Secures USFDA Final Approval for Macitentan Tablets, Tapping into $1.18 Billion Market
Pharm'Up 
Alembic Pharmaceuticals Limited announced today that it has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg. This key regulatory milestone allows the company to manufacture and market a generic version of the high-value branded drug, Opsumit Tablets, 10 mg, from Actelion Pharmaceuticals US, Inc.
The approval is for a product that is therapeutically equivalent to the reference listed drug (RLD), meaning it has the same active ingredient, strength, dosage form, and route of administration as the brand-name product.
Macitentan is an endothelin receptor antagonist (ERA) specifically indicated for the treatment of pulmonary arterial hypertension (PAH), a severe and life-threatening condition classified as WHO Group I. In adult patients with PAH, the drug is used to help reduce the risks of disease progression and hospitalization.
The approval represents a significant commercial opportunity for Alembic. According to IQVIA, a leading healthcare data and analytics company, the U.S. market for Macitentan Tablets, 10 mg, had an estimated market size of US$ 1,180 million for the twelve months ending in June 2025. This approval further solidifies Alembic’s growing presence in the U.S. generic drug market and its focus on developing complex and high-value products.
With this latest approval, Alembic now holds a cumulative total of 224 ANDA approvals from the USFDA, consisting of 203 final approvals and 21 tentative approvals. This robust track record underscores the company’s strong R&D capabilities and its commitment to providing affordable alternatives to expensive branded medications in one of the world’s most lucrative pharmaceutical markets.
This development follows Alembic’s strategy of expanding its portfolio in specialized therapeutic areas and is expected to contribute to the company’s revenue growth in the coming years.
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