Generic Treprostinil Available as Under-the-skin Injection

Sandoz‘s generic treprostinil injection now is available for subcutaneous (under-the-skin) administration to treat  pulmonary arterial hypertension (PAH), the company announced in a press release.

Treprostinil first was approved to treat PAH in the U.S. in 2002. It was developed by United Therapeutics, which markets the medication under the brand name Remodulin.

Generic formulations of the medication — meaning versions that contain the same active ingredient(s), with the same strengths as the brand-name medicine, but are sold at a lower price — have become available in recent years.

Sandoz’s generic formulation of treprostinil, first launched in 2019, had previously been available only as an intravenous injection, where the medication is injected directly into the bloodstream. Now, it also is available for subcutaneous injection — when the medication is injected just below the surface of the skin.

Broadly, subcutaneous injections are considered more convenient and less risky.

Both intravenous and subcutaneous formulations of Sandoz’s generic treprostinil will be available at the same specialty pharmacy that dispenses the brand name medicine, the company said.

The subcutaneous version will be commercialized through an agreement with Liquidia Corporation, which previously announced that the U.S. Food and Drug Administration (FDA) had cleared the use of a new cartridge with the Smiths Medical’s CADD-MS 3 pump, which has been used to subcutaneously administer the brand-name medication for more than a decade.

According to Sandoz, the cartridges needed to operate the CADD-MS 3 pump were not available to individuals using generic forms of the medication due to restrictions imposed by other companies.

“The FDA clearance of a path to bring additional new cartridges required for subcutaneous administration of this medicine means another option for patients who need access to this life-enhancing pulmonary arterial hypertension medicine,” said Keren Haruvi, president of Sandoz.

The new cartridge is called RG 3ml Medication Cartridge, and enables the use of subcutaneous administration of Sandoz generic treprostinil for the first time.

“We are excited to provide a new option in the parenteral use of Treprostinil Injection. Patients who need and depend on SC administered treprostinil will now, for the first time, have access to a lower cost generic treprostinil. Through our agreement with Sandoz, we will continue to provide the same level of high-touch support and services to our patients, but at a lower cost compared to the branded product,” said Scott Moomaw, senior vice president of commercial at Liquidia.