Mesoblast (MESO) said late Wednesday it received seven years of orphan drug exclusivity from the US Food and Drug Administration for Ryoncil, a treatment approved for steroid-refractory acute graft versus host disease in children aged two months and older.
The company said the exclusivity means that the US health agency can not approve any mesenchymal stromal or stem cell products for the same use during this period.
Additionally, the company said Ryoncil has 12 years of biologic exclusivity, blocking biosimilar competition until December 2036.
The statutory protections add to Mesoblast's US patents position on MSC composition of matter, manufacturing, and indications that provide a commercial barrier to entry against competitors through 2044, it added.
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