The generic version of Opsumit is likely to be available after 18 April, 2029. The last patent for Opsumit, held by Actelion, expires on this date. The arrival of Opsumit generic could be even earlier if there is a successful Para IV filing.
Opsumit is primarily used for treating pulmonary arterial hypertension (PAH). It works effectively because of its active ingredient, macitentan, and the inclusion of a polysorbate in its composition. The pharmaceutical composition of Opsumit can also be used in combination with a compound having phosphodiesterase-5 inhibitory properties for treating pulmonary hypertension.
Opsumit, owned by Actelion, is protected by 5 patents. The patents cover different aspects of the drug, including its unique composition and method of treatment. The last patent protecting the Opsumit generic is set to expire on 18 April, 2029. Below are the details of the patent: