66 drugs reach their earliest generic-entry date in 2035

Jan 2035 · 2

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Nityr · 3 strengths nitisinone	nitisinone	Cycle	209449	5 Jan 2035	patent
Vasostrict · 4 strengths vasopressin	vasopressin	Ph Health	204485	30 Jan 2035	patent

Feb 2035 · 3

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Licart diclofenac epolamine	diclofenac epolamine	Ibsa Inst Bio	206976	20 Feb 2035	patent, carve-out possible
Zituvio · 3 strengths sitagliptin	sitagliptin	Zydus Lifesciences	211566	25 Feb 2035	patent
Bafiertam monomethyl fumarate	monomethyl fumarate	Banner Life Sciences	210296	27 Feb 2035	patent

Mar 2035 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Impoyz clobetasol propionate	clobetasol propionate	Primus Pharms	209483	11 Mar 2035	patent
Adrenalin epinephrine	epinephrine	Ph Health	204640	13 Mar 2035	patent
Adrenalin epinephrine	epinephrine	Ph Health	204200	13 Mar 2035	patent
Firvanq Kit · 2 strengths vancomycin hydrochloride	vancomycin hydrochloride	Azurity	208910	13 Mar 2035	patent
Pemetrexed · 3 strengths pemetrexed disodium	pemetrexed disodium	Shilpa	215179	26 Mar 2035	patent

Apr 2035 · 7

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Qalsody tofersen	tofersen	Biogen Ma	215887	1 Apr 2035	patent
Qelbree · 3 strengths viloxazine hydrochloride	viloxazine hydrochloride	Supernus Pharms	211964	2 Apr 2035	patent
Symdeko (Copackaged) · 2 strengths ivacaftor; ivacaftor, tezacaftor	ivacaftor; ivacaftor, tezacaftor	Vertex Pharms Inc	210491	14 Apr 2035	patent
Alecensa alectinib hydrochloride	alectinib hydrochloride	Hoffmann-La Roche	208434	24 Apr 2035	patent
Imbruvica · 2 strengths ibrutinib	ibrutinib	Pharmacyclics Llc	205552	24 Apr 2035	patent
Jublia efinaconazole	efinaconazole	Bausch	203567	25 Apr 2035	patent
Copiktra · 2 strengths duvelisib	duvelisib	Secura	211155	26 Apr 2035	patent, carve-out possible

May 2035 · 3

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Dawnzera (Autoinjector) donidalorsen sodium	donidalorsen sodium	Ionis Pharms Inc	219407	1 May 2035	patent
Arikayce Kit amikacin sulfate	amikacin sulfate	Insmed Inc	207356	15 May 2035	patent, carve-out possible
Velphoro ferric oxyhydroxide	ferric oxyhydroxide	Vifor Fresenius	205109	26 May 2035	patent

Jun 2035 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Tauklarify florquinitau f-18	florquinitau f-18	Cerveau Lantheus	220496	9 Jun 2035	patent
Rhofade oxymetazoline hydrochloride	oxymetazoline hydrochloride	Mayne Pharma	208552	11 Jun 2035	patent, carve-out possible
Zilbrysq · 3 strengths zilucoplan sodium	zilucoplan sodium	Ucb Inc	216834	12 Jun 2035	patent
Ojemda tovorafenib	tovorafenib	Day One Biopharms	217700	23 Jun 2035	patent
Ojemda tovorafenib	tovorafenib	Day One Biopharms	218033	23 Jun 2035	patent
Cyclophosphamide · 3 strengths cyclophosphamide	cyclophosphamide	Eugia Pharma Speclts	210735	26 Jun 2035	patent

Jul 2035 · 9

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Kapspargo Sprinkle · 4 strengths metoprolol succinate	metoprolol succinate	Spil	210428	9 Jul 2035	patent
Kengreal cangrelor	cangrelor	Chiesi	204958	10 Jul 2035	patent
Zelsuvmi berdazimer sodium	berdazimer sodium	Lnhc	217424	10 Jul 2035	patent
Kimyrsa oritavancin diphosphate	oritavancin diphosphate	Melinta Therap	214155	16 Jul 2035	patent
Orbactiv oritavancin diphosphate	oritavancin diphosphate	Melinta Therap	206334	16 Jul 2035	patent
Tabrecta · 2 strengths capmatinib hydrochloride	capmatinib hydrochloride	Novartis Pharm	213591	22 Jul 2035	patent
Gozellix gallium ga-68 gozetotide	gallium ga-68 gozetotide	Telix Innovations	219592	28 Jul 2035	patent, carve-out possible
Illuccix gallium ga-68 gozetotide	gallium ga-68 gozetotide	Telix	214032	28 Jul 2035	patent, carve-out possible
Kerendia · 3 strengths finerenone	finerenone	Bayer Hlthcare	215341	29 Jul 2035	patent

Aug 2035 · 7

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Absorica Ld · 4 strengths isotretinoin	isotretinoin	Sun Pharm	211913	4 Aug 2035	patent
Xpovio · 6 strengths selinexor	selinexor	Karyopharm Theraps	212306	14 Aug 2035	patent
Rubraca · 3 strengths rucaparib camsylate	rucaparib camsylate	Pharmaand	209115	17 Aug 2035	patent
Lisraya brepocitinib tosylate	brepocitinib tosylate	Priovant Therap	220106	19 Aug 2035	patent
Onpattro patisiran sodium	patisiran sodium	Alnylam Pharms Inc	210922	27 Aug 2035	patent
Sotylize sotalol hydrochloride	sotalol hydrochloride	Azurity	205108	31 Aug 2035	patent
Vyndamax tafamidis	tafamidis	Foldrx Pharms	212161	31 Aug 2035	patent

Sep 2035 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Fetroja cefiderocol sulfate tosylate	cefiderocol sulfate tosylate	Shionogi	209445	3 Sep 2035	patent
Fruzaqla · 2 strengths fruquintinib	fruquintinib	Takeda Pharms Usa	217564	7 Sep 2035	patent
Aponvie aprepitant	aprepitant	Heron Theraps Inc	216457	18 Sep 2035	patent
Cinvanti aprepitant	aprepitant	Heron Theraps Inc	209296	18 Sep 2035	patent
Akynzeo netupitant; palonosetron hydrochloride	netupitant; palonosetron hydrochloride	Helsinn Hlthcare	205718	25 Sep 2035	patent

Oct 2035 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Isturisa · 2 strengths osilodrostat phosphate	osilodrostat phosphate	Recordati Rare	212801	12 Oct 2035	patent, carve-out possible
Lokelma · 2 strengths sodium zirconium cyclosilicate	sodium zirconium cyclosilicate	Astrazeneca	207078	14 Oct 2035	patent
Tyrvaya varenicline tartrate	varenicline tartrate	Oyster Point Pharma	213978	19 Oct 2035	patent
Dayvigo · 2 strengths lemborexant	lemborexant	Eisai Inc	212028	21 Oct 2035	patent
Accrufer ferric maltol	ferric maltol	Shield Tx	212320	23 Oct 2035	patent
Jylamvo methotrexate	methotrexate	Shorla	212479	28 Oct 2035	patent

Nov 2035 · 8

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Qbrelis lisinopril	lisinopril	Azurity	208401	6 Nov 2035	patent
Sublocade buprenorphine	buprenorphine	Indivior	209819	6 Nov 2035	patent, carve-out possible
Tyzavan · 7 strengths vancomycin hydrochloride	vancomycin hydrochloride	Hikma	211962	6 Nov 2035	patent
Alunbrig · 3 strengths brigatinib	brigatinib	Takeda Pharms Usa	208772	10 Nov 2035	patent
Vykat Xr · 3 strengths diazoxide choline	diazoxide choline	Soleno	216665	12 Nov 2035	patent, carve-out possible
Tecfidera · 2 strengths dimethyl fumarate	dimethyl fumarate	Biogen	204063	16 Nov 2035	patent, carve-out possible
Xacduro (Copackaged) durlobactam sodium; durlobactam sodium; sulbactam sodium	durlobactam sodium; durlobactam sodium; sulbactam sodium	Entasis Therap	216974	17 Nov 2035	patent
Cytalux pafolacianine sodium	pafolacianine sodium	On Target Labs	214907	29 Nov 2035	patent

Dec 2035 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Frindovyx · 3 strengths cyclophosphamide	cyclophosphamide	Avyxa Holdings	210852	1 Dec 2035	patent
Arakoda tafenoquine succinate	tafenoquine succinate	60 Degrees Pharms	210607	2 Dec 2035	patent, carve-out possible
Mavyret glecaprevir; pibrentasvir	glecaprevir; pibrentasvir	Abbvie	215110	5 Dec 2035	patent
Nuzolvence zoliflodacin	zoliflodacin	Entasis Therap	219491	12 Dec 2035	exclusivity
Xenoview xenon xe-129 hyperpolarized	xenon xe-129 hyperpolarized	Polarean	214375	29 Dec 2035	patent