FDA Approves Alembic’s Generic Injection of Remodulin for PAH

The U.S. Food and Drug Administration (FDA) has approved Alembic Pharmaceuticals’ injectable formulation of treprostinil, a generic version of Remodulin, to treat patients with pulmonary arterial hypertension (PAH), the company announced.

Like the branded product, this generic version of United Therapeutics’ treprostinil will be available in multiple-dose vials containing four different concentrations  — 1.0, 2.5, 5.0, and 10 mg/mL — of the medication’s active ingredient.

The FDA’s decision to approve this generic version of treprostinil followed the company’s submission of an abbreviated new drug application (ANDA), according to an Alembic press release. Manufacturers may submit an ANDA to regulatory health agencies requesting the approval of their generic products.

To be approved via ANDA, manufacturers must provide evidence that their generic products are biologically and therapeutically equivalent to the branded medications on which they are based. Once approved, generic manufacturers may then start marketing their products as an equally safe, effective, and less expensive alternative to brand-name medications.

Before receiving a final approval for treprostinil’s ANDA, Alembic’s generic was given tentative approval, meaning that it had been cleared to enter the market but its commercialization was pending the resolution of patent and/or other market exclusivity issues.

Remodulin was originally approved in the U.S. to ease symptoms associated with exercise in people with PAH, as well as to slow the clinical decline of patients needing to discontinue treatment with epoprostenol (sold as Flolan and Veletri), another medication for treating pulmonary arterial hypertension.

The medication’s active ingredient, treprostinil, is a vasodilator agent that can help widen blood vessels in the lungs, lowering blood pressure.

In addition to being available in an injectable formulation, treprostinil also is commercialized by United in the U.S. in an oral form called Orenitram, and in an inhaled form called Tyvaso. A dry-powder inhaled formulation of treprostinil, known as Tyvaso DPI, currently is being developed by United and MannKind as a possibly more convenient alternative to Tyvaso.

According to Iqvia, market sales of injectable treprostinil reached $17 million in the U.S. alone last year.

With headquarters in India, Alembic manufactures and markets generics all over the world. To date, Alembic has received a total of 138 ANDA approvals from the FDA. This is their first injectable ANDA approval in the U.S.