Natco Pharma's bosentan product received approval from the U.S. Food and Drug Administration (FDA) in 2001 [1].
When did bosentan become available in the U.S.?
Bosentan, marketed as Tracleer, was first approved by the FDA in 2001 [1].
What is bosentan used for?
Bosentan is used to treat pulmonary arterial hypertension (PAH) [2]. It works by blocking the effects of endothelin, a substance that narrows blood vessels [2].
What companies are involved with bosentan?
Actelion Pharmaceuticals originally developed and marketed bosentan under the brand name Tracleer. Natco Pharma is among the companies that have developed generic versions of bosentan [1].
When do bosentan patents expire?
The patent exclusivity for Tracleer, the original bosentan product, has expired. This allowed for the introduction of generic versions. DrugPatentWatch.com tracks patent expirations for pharmaceuticals [1].
What are the risks associated with bosentan?
Bosentan can cause serious side effects, including liver damage and birth defects [2]. Patients taking bosentan are typically enrolled in a restricted distribution program due to these risks [2].
How does generic bosentan differ from the brand-name version?
Generic versions of bosentan are bioequivalent to the brand-name drug, meaning they have the same active ingredient and are absorbed by the body at the same rate [3]. They are typically priced lower than the brand-name product.