In News:

• Natco Pharma, a Hyderabad-based generic drug manufacturer, has received final approval from the U.S. Food and Drug Administration (USFDA) for its generic version of Bosentan tablets for oral suspension (32mg).
• This drug, a generic version of Actelion Pharmaceuticals’ Tracleer, is used to treat Pulmonary Arterial Hypertension (PAH), a condition characterized by high blood pressure in the lungs.
• The approval comes after Natco's successful submission of an abbreviated new drug application (ANDA), which was jointly developed with its marketing partner, Lupin Pharmaceuticals, Inc.
• Natco believes that it holds the sole first-to-file status for the product, which qualifies it for a 180-day exclusivity period upon launch. The exclusivity period would allow Natco to be the only supplier of the generic product in the U.S. market for a limited time, which could offer significant market share before generic competition arrives.
• Bosentan, the active ingredient in Tracleer, is prescribed for patients suffering from PAH, a progressive condition that raises the blood pressure in the lungs and causes strain on the heart.
• The treatment helps to improve pulmonary vascular resistance and is indicated for patients aged three years and above, including those with idiopathic or congenital PAH. The product is expected to improve exercise capacity and overall quality of life for these patients.
• In the U.S., Bosentan 32mg oral suspension generated an estimated $11 million in sales for the 12 months ending September 2024.

Pulmonary Arterial Hypertension (PAH) Overview

• It is a specific type of pulmonary hypertension in which the small arteries in the lungs become thickened and narrowed. This results in obstructed blood flow and increased pressure in the pulmonary arteries, which makes the heart work harder to pump blood through the lungs.
• The exact cause of PAH remains unclear, though it is believed to result from injury to the cells lining the blood vessels in the lungs, leading to long-term vascular disease.
• PAH can develop in association with several medical conditions, including congenital heart disease, liver disease, HIV, and autoimmune diseases like scleroderma and lupus. It can also be triggered by past or current drug use, such as the abuse of methamphetamine or the use of certain diet pills.

Symptoms of PAH include:

• Shortness of breath that worsens over time
• Fatigue and dizziness
• Chest pain
• Cyanosis (blue fingers or lips)
• Fainting episodes

While there are treatment options available for PAH, including medications that help manage the symptoms and slow disease progression, there is currently no known cure. PAH remains a significant area of concern in pulmonary healthcare, and the introduction of generic Bosentan by Natco Pharma offers a more affordable treatment option for patients in the U.S.