Applicant, as named in the Orange Book

Biogen

Next listed expiry: Spinraza on 23 Dec 2030. 4 products with live protection, 0 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Spinraza · 3 strengths nusinersen sodium	nusinersen sodium	209531	23 Dec 2030	patent, carve-out possible
Vumerity diroximel fumarate	diroximel fumarate	211855	29 Oct 2033	patent
Tecfidera · 2 strengths dimethyl fumarate	dimethyl fumarate	204063	16 Nov 2035	patent, carve-out possible
Zurzuvae · 3 strengths zuranolone	zuranolone	217369	23 Aug 2037	patent

Vumerity · First generic approved · ANDA 218596, ZydusApproved 12 Nov 2025Detected 25 Oct 2026
Vumerity · Generic approved · ANDA 218596, ZydusApproved 12 Nov 2025Detected 25 Oct 2026