NATCO Gets Final Approval for Bosentan Tablets for Oral Suspension Treatment

Hyderabad-based NATCO Pharma has received final approval for its Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension (TFOS), 32mg. The drug is a generic version of Tracleer®, originally developed by Actelion Pharmaceuticals US Inc.

First-to-File Status 

NATCO claims to have First-to-File (FTF) status for this drug, which means it is eligible for 180 days of marketing exclusivity in the U.S. This exclusivity period allows the company to be the only generic manufacturer of the drug for six months after launch. However, details about the launch timeline remain undisclosed.

Partnership with Lupin

The product will be marketed in the U.S. by Lupin Pharmaceuticals, Inc., NATCO’s partner for this ANDA. Lupin will handle distribution, but there is no official confirmation on the expected availability of the product in the market.

Indication and Usage

Bosentan TFOS is prescribed for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in children aged three years and older with idiopathic or congenital PAH. The drug is intended to help lower pulmonary vascular resistance (PVR), which may improve exercise ability in affected patients.

Company Background

NATCO Pharma develops and manufactures generic and specialty pharmaceuticals. The company has nine manufacturing sites and two R&D facilities in India and is involved in both domestic and international markets. Its products are approved by multiple global regulatory authorities, including the U.S. FDA, Health Canada, Brazil ANVISA, and WHO.

Natco Pharma Ltd shares were trading at ₹1,294.05, down ₹25.35 (1.92%) as of February 10, 11:45 AM. Over the past six months, the stock has declined by 13.41%, but it remains up 55.25% over the past year.

Further details on the product launch and distribution remain unavailable at this time.

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