Applicant, as named in the Orange Book

Janssen Biotech

Next listed expiry: Balversa on 2 Feb 2038. 6 products with live protection, 1 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Balversa · 3 strengths erdafitinib	erdafitinib	212018	2 Feb 2038	patent, carve-out possible
Inlexzo gemcitabine hydrochloride	gemcitabine hydrochloride	219683	7 Nov 2038	patent, carve-out possible
Erleada · 2 strengths apalutamide	apalutamide	210951	14 Jan 2041	patent, carve-out possible
Lazcluze · 2 strengths lazertinib mesylate	lazertinib mesylate	219008	1 Aug 2041	patent, carve-out possible
Icotyde icotrokinra hydrochloride	icotrokinra hydrochloride	220149	19 Nov 2041	patent
Akeega · 2 strengths abiraterone acetate; niraparib tosylate	abiraterone acetate; niraparib tosylate	216793	30 Sep 2043	patent, carve-out possible

Recent events

25 Oct 2026Balversa · Generic tentatively approved 2 Feb 2026
24 Oct 2026Balversa · Exclusivity expires within 90 days I-93019 Jan 2027
24 Oct 2026Balversa · Exclusivity expires within 90 days I-93019 Jan 2027
24 Oct 2026Balversa · Exclusivity expires within 90 days I-93019 Jan 2027

Products without listed protection (1)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Zytiga · 2 strengths abiraterone acetate	abiraterone acetate	202379	open now	no listed protection