Sandoz exclusively launches treprostinil injection, the first generic version of Remodulin, in the US

Sandoz today announced the US availability of Treprostinil Injection, the first fully substitutable AP rated generic version of Remodulin®* (treprostinil) Injection, sold by United Therapeutics Corporation, including 180 days of marketing exclusivity for the product.

Treprostinil is indicated for Pulmonary Arterial Hypertension (PAH); World Health Organization (WHO) Group 1 to diminish symptoms associated with exercise. PAH is a progressive disease, resulting in heart failure and shortened life expectancy. About 52,000 patients have been diagnosed with PAH in the US, with rates expected to rise due to increased survival and diagnosis rates1.

"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). RareGen, LLC is backed by PBM Capital Group; PBM Capital Group is a healthcare investor and operator.

According to United Therapeutics Corporation FY 2018 results, global sales for Treprostinil were approximately USD 599 million in 20182.

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