J&J's Actelion buyout pays off again with approval of Opsynvi in pulmonary arterial hypertension

25 Mar 2024

Drug ApprovalBiosimilarPatent ExpirationAcquisition

Johnson & Johnson scored an FDA approval for Opsynvi, a combo of the endothelin receptor antagonist Opsumit and the phosphodiesterase 5 inhibitor tadalafil, for the treatment of pulmonary arterial hypertension. The combo is approved both for patients in the first-line setting as well as those who have already been treated with Opsumit and tadalafil as separate tablets. J&J owns Opsumit through its buyout of Actelion and tadalafil is the active ingredient of an Eli Lilly drug (Cialis) that has since hit the generic market. Opsumit is a blockbuster drug that brought in $1.9 billion in 2023 and was first approved in 2013 to treat pulmonary arterial hypertension. It faces a 2025 patent cliff.

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Organizations

Johnson & Johnson

Actelion Ltd.

Indications

Pulmonary Arterial Hypertension

Targets

Drugs

Nuclear Receptor Antagonist(Boehringer Ingelheim)MacitentanTadalafil

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