Applicant, as named in the Orange Book

Janssen Biotech

Johnson & Johnson · NYSE: JNJ

Company and ticker: cliffwatch mapping, checked against SEC EDGAR · SEC filings

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

Products with listed protection

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

Balversa · Generic tentatively approved · ANDA 218578, Natco Pharma LtdTentative approval 2 Feb 2026Detected 25 Oct 2026
Balversa · Exclusivity expires within 90 days I-930Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
Balversa · Exclusivity expires within 90 days I-930Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
Balversa · Exclusivity expires within 90 days I-930Exclusivity expires 19 Jan 2027Detected 24 Oct 2026

Products without listed protection (1)

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