Sandoz launches generic Remodulin
Sandoz is offering treprostinil injection, the first generic of United Therapeutics’ Remodulin.
The product is indicated for pulmonary arterial hypertension to reduce symptoms associated with exercise.
Pulmonary arterial hypertension is high blood pressure in the arteries of the lungs. It is a progressive disease, resulting in heart failure and shortened life expectancy. About 52,000 patients have been diagnosed with pulmonary arterial hypertesnsion in the United States, 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,” Sandoz president Carol Lynch said. “At Sandoz, we believe in reimagining the care of patients by bringing complex generics, like treprostinil, to U.S. patients and providing access to cost-effective, high-quality medicines.”
Sandoz will collaborate with RareGen 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). .
Global sales for treprostinil were approximately $599 million in 2018, according to United Therapeutics’ 2018 results.
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