Natco Pharma files ANDA for generic version of Bosentan tablets for oral suspension

Bosentan 32 mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson and Johnson) under the brand name Tracleer.

Hyderabad: City-based Natco Pharma Limited has recently submitted an Abbreviated New Drug Application (ANDA) with Para IV certification of with the U.S Food and Drug Administration (USFDA) for the generic version of Bosentan 32 mg tablets for oral suspension.

Bosentan 32 mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson and Johnson) under the brand name Tracleer.

Tracleer is indicated for the treatment of pulmonary arterial hypertension. As per Johnson and Johnson' s (JnJ) annual report for the year ending 2018, Tracleer had registered sales of approximately $268 million in the US market and the 32 mg is one strength that is indicated for a paediatric patient.

Natco believes that its ANDA is possibly the sole first-to-file based on the filing date.

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"We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of the potential launch of the product," said Natco in a release.

Natco Pharma was established in 1981 as a private limited company. The company develops, manufactures and markets finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs). The company's major product categories include Domestic Formulations, International Formulations, APIs and Blockbusters.

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