Applicant, as named in the Orange Book

Actelion

Next listed expiry: Veletri on 15 Mar 2027. 6 products with live protection, 2 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Veletri · 2 strengths epoprostenol sodium	epoprostenol sodium	022260	15 Mar 2027	patent
Tracleer bosentan	bosentan	209279	28 Dec 2027	patent
Opsumit macitentan	macitentan	204410	18 Oct 2029	patent
Uptravi selexipag	selexipag	214275	1 Feb 2031	patent
Opsynvi · 2 strengths macitentan; tadalafil	macitentan; tadalafil	218490	22 Sep 2031	exclusivity
Uptravi · 10 strengths selexipag	selexipag	207947	1 Jun 2037	patent

Recent events

25 Oct 2026Opsumit · Generic approved 3 Dec 2025
25 Oct 2026Opsumit · Generic approved 8 Jun 2026
25 Oct 2026Ventavis · First generic approved 10 Jul 2026
25 Oct 2026Ventavis · Generic approved 10 Jul 2026
25 Oct 2026Opsumit · Generic approved 5 Nov 2025
25 Oct 2026Veletri · Generic approved 29 Dec 2025
25 Oct 2026Opsumit · Generic approved 8 Jun 2026
25 Oct 2026Opsumit · Generic approved 3 Dec 2025
25 Oct 2026Uptravi · Generic approved 16 Apr 2026
25 Oct 2026Tracleer · Generic approved 17 Feb 2026
25 Oct 2026Uptravi · Generic tentatively approved 16 Jan 2026
24 Oct 2026Veletri · Enters 12-month window basis: patent15 Mar 2027
24 Oct 2026Veletri · Enters 12-month window basis: patent15 Mar 2027

Products without listed protection (2)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Tracleer · 2 strengths bosentan	bosentan	021290	open now	no listed protection
Zavesca miglustat	miglustat	021348	open now	no listed protection