Alembic Pharmaceuticals’ Bosentan Tablets, Generic to Tracleer, Approved by the FDA

A new generic version of Actelion’s Tracleer (bosentan), developed by Alembic Pharmaceuticals, has been approved by the U.S. Food and Drug Administration (FDA) for treating pulmonary arterial hypertension (PAH).

The approval comes after Alembic submitted an abbreviated new drug application (ANDA) for generic bosentan tablets. ANDA is an application for a generic drug approval in the U.S. that is based on an existing licensed medication or approved therapy.

A generic is a medicine developed to be the same as an existing approved brand-name therapy with regards to dosage, safety, strength, route of administration, quality, and performance characteristics. The generic has a similar mechanism of action and the same clinical benefits as its brand-name version.

According to a press release from Alembic, the company’s bosentan tablets were proven to be therapeutically equivalent to the already approved Tracleer therapy. The generic bosentan tablets will be available at two doses: 62.5 mg and 125 mg.

Bosentan works by blocking the action of endothelin-1 (ET-1), which is a protein that causes blood vessels to constrict (narrow).

In healthy people, ET-1 plays a role in maintaining a balance between high and low blood pressure. However, PAH patients tend to produce too much ET-1, leading to high levels of ET-1 protein in both the bloodstream and the endothelium (the cells that line blood vessels).

By blocking ET-1, bosentan helps blood vessels relax, and increases blood flow to the lungs.

Tracleer was approved in 2001 by the FDA for adults with PAH who have significant limitation of physical activity (WHO class III and IV). The therapy is indicated to improve exercise ability, and decrease the rate of clinical worsening in PAH patients.

In 2017, Tracleer was granted approval by the FDA for use in children with PAH, making it the first FDA-approved treatment for those patients.

Tracleer is available as 32 mg (for children), 62.5 mg, and 125 mg tablets (oral formulation).

In addition to Alembic’s bosentan tablets, another generic to Tracleer was approved by the FDA in 2019: Teva Pharmaceutical’s bosentan tablets (62.5 mg and 125 mg doses).

With headquarters in India, Alembic manufactures and markets generics all over the world. According to the company, its state of the art research, development, and manufacturing facilities have been approved by regulatory authorities in several countries, including the U.S.

To date, Alembic has received a total of 114 ANDA approvals — 102 final approvals and 12 tentative approvals — from the FDA.