Applicant, as named in the Orange Book

Novartis

Next listed expiry: Gilenya on 25 Dec 2027. 25 products with live protection, 29 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Gilenya · 2 strengths fingolimod hydrochloride	fingolimod hydrochloride	022527	25 Dec 2027	patent, carve-out possible
Afinitor · 4 strengths everolimus	everolimus	022334	1 Jul 2028	patent, carve-out possible
Tykerb lapatinib ditosylate	lapatinib ditosylate	022059	18 Sep 2029	patent
Rydapt midostaurin	midostaurin	207997	2 Dec 2030	patent, carve-out possible
Mekinist trametinib dimethyl sulfoxide	trametinib dimethyl sulfoxide	217513	15 Apr 2031	patent
Netspot gallium dotatate ga-68	gallium dotatate ga-68	208547	10 Aug 2032	patent
Tasigna · 3 strengths nilotinib hydrochloride	nilotinib hydrochloride	022068	7 Oct 2032	patent
Piqray · 3 strengths alpelisib	alpelisib	212526	29 Apr 2033	patent
Mekinist · 2 strengths trametinib dimethyl sulfoxide	trametinib dimethyl sulfoxide	204114	28 Feb 2034	patent
Tafinlar · 2 strengths dabrafenib mesylate	dabrafenib mesylate	202806	28 Feb 2034	patent
Locametz gallium ga-68 gozetotide	gallium ga-68 gozetotide	215841	9 Mar 2036	patent, carve-out possible
Mayzent · 3 strengths siponimod	siponimod	209884	23 Apr 2036	patent, carve-out possible
Leqvio inclisiran sodium	inclisiran sodium	214012	25 Aug 2036	patent, carve-out possible
Kisqali ribociclib succinate	ribociclib succinate	209092	14 Oct 2036	patent
Kisqali Femara Co-Pack (Copackaged) letrozole; ribociclib succinate	letrozole; ribociclib succinate	209935	14 Oct 2036	patent
Entresto Sprinkle · 2 strengths sacubitril; valsartan	sacubitril; valsartan	218591	2 Feb 2037	patent
Vijoice alpelisib	alpelisib	218466	17 Feb 2037	patent, carve-out possible
Vijoice · 3 strengths alpelisib	alpelisib	215039	17 Feb 2037	patent, carve-out possible
Zykadia ceritinib	ceritinib	211225	13 Dec 2037	patent, carve-out possible
Tafinlar dabrafenib mesylate	dabrafenib mesylate	217514	29 Dec 2038	patent
Scemblix · 3 strengths asciminib hydrochloride	asciminib hydrochloride	215358	17 May 2040	patent, carve-out possible
Fabhalta iptacopan hydrochloride	iptacopan hydrochloride	218276	15 Jul 2041	patent, carve-out possible
Pluvicto lutetium lu-177 vipivotide tetraxetan	lutetium lu-177 vipivotide tetraxetan	215833	18 Sep 2041	patent, carve-out possible
Rhapsido remibrutinib	remibrutinib	218436	19 Jan 2043	patent, carve-out possible
Vanrafia atrasentan hydrochloride	atrasentan hydrochloride	219208	25 Mar 2043	patent, carve-out possible

Recent events

25 Oct 2026Afinitor · Generic approved 25 Feb 2026
25 Oct 2026Tasigna · Generic approved 19 Nov 2025
25 Oct 2026Afinitor · Generic approved 12 May 2026
25 Oct 2026Afinitor · Generic approved 30 Jun 2026
25 Oct 2026Tasigna · Generic approved 19 Nov 2025
25 Oct 2026Promacta · Generic approved 8 Apr 2026
25 Oct 2026Mayzent · Generic approved 6 Mar 2026
25 Oct 2026Diovan · Generic approved 21 Apr 2026
25 Oct 2026Diovan Hct · Generic approved 23 Apr 2026
25 Oct 2026Zometa · Generic approved 5 Feb 2026
25 Oct 2026Afinitor · Generic approved 30 Oct 2025
25 Oct 2026Promacta · Generic approved 13 Jul 2026
25 Oct 2026Voltaren · Generic approved 5 Nov 2025
25 Oct 2026Promacta · Generic approved 14 Jan 2026
25 Oct 2026Sandimmune · Generic approved 17 Sep 2026
25 Oct 2026Tasigna · Generic approved 19 Nov 2025
25 Oct 2026Promacta · Generic approved 28 Apr 2026
25 Oct 2026Trileptal · Generic approved 29 Apr 2026
25 Oct 2026Promacta · Generic approved 17 Jun 2026
25 Oct 2026Diovan · Generic approved 11 Aug 2026
25 Oct 2026Sandostatin Lar · Generic approved 12 Dec 2025
25 Oct 2026Promacta · Generic approved 14 Jan 2026
25 Oct 2026Tasigna · Generic approved 26 Jun 2026
25 Oct 2026Gilenya · Generic approved 24 Apr 2026
25 Oct 2026Trileptal · Generic approved 9 Mar 2026
25 Oct 2026Promacta · Generic approved 14 Jan 2026
25 Oct 2026Trileptal · Generic approved 2 Mar 2026
25 Oct 2026Trileptal · Generic approved 29 May 2026
24 Oct 2026Scemblix · Exclusivity expires within 90 days NCE29 Oct 2026
24 Oct 2026Scemblix · Exclusivity expires within 90 days NCE29 Oct 2026
24 Oct 2026Scemblix · Exclusivity expires within 90 days NCE29 Oct 2026
24 Oct 2026Piqray · Exclusivity expires within 90 days I-93718 Jan 2027
24 Oct 2026Piqray · Exclusivity expires within 90 days I-93718 Jan 2027
24 Oct 2026Piqray · Exclusivity expires within 90 days I-93718 Jan 2027
24 Oct 2026Leqvio · Exclusivity expires within 90 days NCE22 Dec 2026

Products without listed protection (29)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Betoptic S betaxolol hydrochloride	betaxolol hydrochloride	019845	open now	no listed protection
Coartem artemether; lumefantrine	artemether; lumefantrine	022268	open now	no listed protection
Diovan · 4 strengths valsartan	valsartan	021283	open now	no listed protection
Diovan Hct · 5 strengths hydrochlorothiazide; valsartan	hydrochlorothiazide; valsartan	020818	open now	no listed protection
Egaten triclabendazole	triclabendazole	208711	open now	no listed protection
Exforge · 4 strengths amlodipine besylate; valsartan	amlodipine besylate; valsartan	021990	open now	no listed protection
Exforge Hct · 5 strengths amlodipine besylate; hydrochlorothiazide; valsartan	amlodipine besylate; hydrochlorothiazide; valsartan	022314	open now	no listed protection
Exjade · 3 strengths deferasirox	deferasirox	021882	open now	no listed protection
Gleevec · 2 strengths imatinib mesylate	imatinib mesylate	021588	open now	no listed protection
Jadenu Sprinkle · 3 strengths deferasirox	deferasirox	207968	open now	no listed protection
Myfortic · 2 strengths mycophenolate sodium	mycophenolate sodium	050791	open now	no listed protection
Neoral cyclosporine	cyclosporine	050716	open now	no listed protection
Neoral · 2 strengths cyclosporine	cyclosporine	050715	open now	no listed protection
Promacta · 4 strengths eltrombopag olamine	eltrombopag olamine	022291	open now	no listed protection
Promacta Kit · 2 strengths eltrombopag olamine	eltrombopag olamine	207027	open now	no listed protection
Sandimmune cyclosporine	cyclosporine	050573	open now	no listed protection
Sandimmune · 3 strengths cyclosporine	cyclosporine	050625	open now	no listed protection
Sandimmune cyclosporine	cyclosporine	050574	open now	no listed protection
Sandostatin · 3 strengths octreotide acetate	octreotide acetate	019667	open now	no listed protection
Sandostatin Lar · 3 strengths octreotide acetate	octreotide acetate	021008	open now	no listed protection
Tegretol carbamazepine	carbamazepine	018927	open now	no listed protection
Tegretol carbamazepine	carbamazepine	016608	open now	no listed protection
Tegretol-Xr · 3 strengths carbamazepine	carbamazepine	020234	open now	no listed protection
Tobradex dexamethasone; tobramycin	dexamethasone; tobramycin	050616	open now	no listed protection
Tobrex tobramycin	tobramycin	050555	open now	no listed protection
Trileptal · 3 strengths oxcarbazepine	oxcarbazepine	021014	open now	no listed protection
Trileptal oxcarbazepine	oxcarbazepine	021285	open now	no listed protection
Votrient pazopanib hydrochloride	pazopanib hydrochloride	022465	open now	no listed protection
Zortress · 4 strengths everolimus	everolimus	021560	open now	no listed protection