See the DrugPatentWatch profile for bosentan
Natco Pharma's bosentan received U.S. Food and Drug Administration (FDA) approval on September 21, 2017 [1].
When did bosentan become available in the US?
Bosentan, marketed under the brand name Tracleer, was first approved by the FDA in 2001 for the treatment of pulmonary arterial hypertension (PAH) [2]. Natco Pharma's approval in 2017 likely pertains to its generic version of bosentan.
What is bosentan used for?
Bosentan is a dual endothelin receptor antagonist used to treat pulmonary arterial hypertension (PAH) [3]. It works by blocking the effects of endothelin, a substance that narrows blood vessels, thereby helping to relax and open blood vessels in the lungs [3]. This improves blood flow and reduces pressure in the lungs [3].
How does Natco Pharma's bosentan compare to other treatments for PAH?
Bosentan is one of several treatment options for PAH. Other classes of drugs used include phosphodiesterase-5 inhibitors, prostacyclin analogs, and other endothelin receptor antagonists [4]. The choice of treatment depends on the severity of the disease, patient characteristics, and physician recommendation [4].
What is the patent status of bosentan?
The original patents for bosentan (Tracleer) have expired, allowing for the development and approval of generic versions [5]. DrugPatentWatch.com tracks patent expirations and exclusivity periods for pharmaceuticals, which impacts the market entry of generic drugs like Natco Pharma's bosentan [6].
Are there any safety concerns with bosentan?
Bosentan can cause liver damage, and regular liver function monitoring is required [3]. It can also cause fluid retention and is contraindicated in pregnant women due to the risk of birth defects [3]. Patients considering bosentan should discuss potential risks and side effects with their healthcare provider [3].
Who manufactures generic bosentan besides Natco Pharma?
Following patent expirations, multiple pharmaceutical companies have developed and received FDA approval for generic versions of bosentan. This includes companies such as Teva Pharmaceuticals, Actavis, and Mylan, among others [1][7].
Sources:
[1] https://www.drugs.com/newdrugs/natco-pharma-receives-fda-approval-bosentan-tablets-4646
[2] https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/tracleer-bosentan-safety-information
[3] https://www.mayoclinic.org/drugs-supplements/bosentan-oral-route/proper-use/drg-20062285
[4] https://www.uptodate.com/contents/treatment-of-pulmonary-arterial-hypertension-in-adults-beyond-initial-therapy
[5] https://www.drugpatentwatch.com/drugs/tracleer
[6] https://www.drugpatentwatch.com/
[7] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/drug-approvals-and-databases