Natco Pharma, in alliance with Lupin, has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg, a generic equivalent of Actelion Pharmaceuticals’ Tracleer Tablets for Oral Suspension. With this approval, Natco becomes the first company to file for the product in the US, granting it 180 days of marketing exclusivity. The generic drug is used to treat pediatric patients with idiopathic or congenital pulmonary arterial hypertension (PAH), helping to improve pulmonary vascular resistance and exercise ability. The estimated annual sales of Tracleer, the reference listed drug, are USD 11 million in the US, based on IQVIA MAT data from December 2024.
Bosentan Tablets for Oral Suspension, 32 mg, is specifically indicated for children aged three and above with idiopathic or congenital PAH. The medication aims to lower pulmonary vascular resistance, which improves exercise ability and quality of life for patients affected by this rare and debilitating disease. With the approval of this generic equivalent, Natco Pharma will be the sole supplier of the product for the next six months, gaining a competitive edge in the US market.
Natco’s ANDA approval underscores the company’s commitment to offering high-quality generic alternatives to brand-name drugs. The company has successfully navigated the FDA approval process, ensuring that its generic product meets stringent standards for quality, safety, and efficacy. The approval is expected to make Bosentan Tablets for Oral Suspension, 32 mg, more accessible and affordable for pediatric patients with PAH, leading to improved patient outcomes and increased access to vital medication.