Liquidia and Sandoz are poised to introduce a generic, subcutaneous version of United Therapeutics’ Remodulin to the U.S. market. Details of the planned launch emerged after Liquidia’s partner secured FDA 510(k) clearance for medication cartridges.
Novartis’ Sandoz and RareGen, now part of Liquidia, launched a generic version of the pulmonary arterial hypertension drug Remodulin in 2019. Teva Pharmaceuticals, Par Sterile Products, Dr. Reddy’s Laboratories and others later got approvals for their own copies. Yet, United Therapeutics has faced minimal erosion of Remodulin sales in the U.S., potentially because of the inability of manufacturers to access the cartridges needed to unlock the preferred subcutaneous administration route.
Sandoz and its marketing partner RareGen took United Therapeutics and pump manufacturer Smiths Medical to court over access to the cartridges. The action led to a settlement in which Smiths Medical paid the plaintiffs $4.25 million, shared cartridge specifications and granted a non-exclusive, royalty-free license to associated patents and copyrights.
Three months after the settlement, Liquidia, which bought RareGen late last year, has said it is set to become the first company to introduce a generic subcutaneous formulation of Remodulin in the U.S.
“We worked hard to overcome this obstacle, and we can now offer generic Treprostinil Injection to more than double the number of PAH patients. We will continue to offer patients, prescribers and payers the same high-touch services and support but at a lower cost compared to the branded product,” Liquidia CEO Damian deGoa said in a statement.
Liquidia provided the update after FDA granted 510(k) clearance to medication cartridges produced by its manufacturing partner Chengdu Shifeng Medical Technologies. The Chengdu cartridges are indicated for use with the CADD-MS 3 pump Smiths Medical manufactures for the subcutaneous delivery of Remodulin.
The subcutaneous launch will step up the generic pressure on Remodulin in the U.S. Globally, United Therapeutics reported a 12% drop in Remodulin sales last year but U.S. generics reportedly played little role in the decline. United Therapeutics attributed the drop to COVID-19 on both sides of the Atlantic and generic competition in Europe.
Ahead of the intensification of U.S. competition, United Therapeutics launched Remunity, a pre-filled, semi-disposable system for subcutaneous delivery of Remodulin. United Therapeutics is also working with Medtronic on an implantable system that it could launch late this year.