The first generic version of Remodulin (treprostinil injection) to treat pulmonary arterial hypertension (PAH) is now available in the United States, according to Sandoz Inc.
The product is sold by United Therapeutics Corporation but Sandoz will be the exclusive marketer of the drug for 180 days.
Treprostinil is indicated for PAH World Health Organization (WHO) Group 1 to diminish symptoms associated with exercise. About 52,000 patients have been diagnosed with PAH in the US, with rates expected to rise due to increased survival and diagnosis rates.
“Pulmonary arterial hypertension is a rare disease that primarily affects women, many in their 30s and 40s, and can have a significant impact on their quality of life as it worsens over time,” said Carol Lynch, President of Sandoz Inc. “At Sandoz, we believe in reimagining the care of patients by bringing complex generics, like treprostinil, to US patients and providing access to cost-effective, high-quality medicines.”
Sandoz will collaborate with RareGen LLC to commercialize Treprostinil Injection, which is supplied in 20 mL multi-dose vials in four strengths – containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL).