Applicant, as named in the Orange Book

Axsome Malta

Next listed expiry: Sunosi on 30 Dec 2042. 1 products with live protection, 0 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Sunosi · 2 strengths solriamfetol hydrochloride	solriamfetol hydrochloride	211230	30 Dec 2042	patent, carve-out possible

Recent events

25 Oct 2026Sunosi · Generic tentatively approved 29 Sep 2026
25 Oct 2026Sunosi · Generic approved 6 Oct 2026
25 Oct 2026Sunosi · First generic approved 17 Jun 2026
25 Oct 2026Sunosi · Generic approved 17 Jun 2026
25 Oct 2026Sunosi · First generic approved 17 Jun 2026
25 Oct 2026Sunosi · Generic approved 17 Jun 2026