59 drugs reach their earliest generic-entry date in 2038

Jan 2038 · 7

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Cysview Kit hexaminolevulinate hydrochloride	hexaminolevulinate hydrochloride	Photocure Asa	022555	4 Jan 2038	patent, carve-out possible
Orserdu · 2 strengths elacestrant hydrochloride	elacestrant hydrochloride	Stemline Therap	217639	5 Jan 2038	patent
Levulan aminolevulinic acid hydrochloride	aminolevulinic acid hydrochloride	Sun Pharm Inds Inc	020965	12 Jan 2038	patent, carve-out possible
Cotempla Xr-Odt · 3 strengths methylphenidate	methylphenidate	Neos Theraps Inc	205489	25 Jan 2038	patent, carve-out possible
Clenpiq citric acid; magnesium oxide; sodium picosulfate	citric acid; magnesium oxide; sodium picosulfate	Ferring Pharms Inc	209589	27 Jan 2038	patent
Norepinephrine Bitartrate In 0.9% Sodium Chloride · 3 strengths norepinephrine bitartrate	norepinephrine bitartrate	Long Grove Pharms	214628	30 Jan 2038	patent
Veppanu · 2 strengths vepdegestrant	vepdegestrant	Rigel Pharms	219835	30 Jan 2038	patent

Feb 2038 · 3

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Balversa · 3 strengths erdafitinib	erdafitinib	Janssen Biotech	212018	2 Feb 2038	patent, carve-out possible
Utebzi tebipenem pivoxil hydrobromide	tebipenem pivoxil hydrobromide	Glaxosmithkline	215960	6 Feb 2038	patent
Barhemsys · 2 strengths amisulpride	amisulpride	Lxo Ireland	209510	9 Feb 2038	patent, carve-out possible

Mar 2038 · 2

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Rinvoq · 3 strengths upadacitinib	upadacitinib	Abbvie	211675	9 Mar 2038	patent, carve-out possible
Livdelzi seladelpar lysine	seladelpar lysine	Gilead Sciences Inc	217899	13 Mar 2038	patent, carve-out possible

Apr 2038 · 3

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Nymalize nimodipine	nimodipine	Azurity	203340	16 Apr 2038	patent
Sincalide sincalide	sincalide	Maia Pharms Inc	210850	20 Apr 2038	patent
Tukysa · 2 strengths tucatinib	tucatinib	Seagen	213411	27 Apr 2038	patent, carve-out possible

May 2038 · 1

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Arazlo tazarotene	tazarotene	Bausch	211882	11 May 2038	patent

Jun 2038 · 3

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Itovebi · 2 strengths inavolisib	inavolisib	Genentech Inc	219249	14 Jun 2038	patent, carve-out possible
Midazolam In 0.9% Sodium Chloride · 2 strengths midazolam	midazolam	Inforlife	211844	20 Jun 2038	patent
Sublocade buprenorphine	buprenorphine	Indivior	209819	22 Jun 2038	patent, carve-out possible

Jul 2038 · 7

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Rezzayo rezafungin acetate	rezafungin acetate	Mundipharma	217417	14 Jul 2038	patent
Trikafta (Copackaged) · 2 strengths elexacaftor, ivacaftor, tezacaftor; ivacaftor	elexacaftor, ivacaftor, tezacaftor; ivacaftor	Vertex Pharms Inc	212273	17 Jul 2038	patent, carve-out possible
Trikafta (Copackaged) elexacaftor, ivacaftor, tezacaftor; ivacaftor	elexacaftor, ivacaftor, tezacaftor; ivacaftor	Vertex Pharms Inc	217660	17 Jul 2038	patent, carve-out possible
Rozlytrek · 2 strengths entrectinib	entrectinib	Genentech Inc	212725	18 Jul 2038	patent
Symtuza cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	Janssen Prods	210455	19 Jul 2038	patent, carve-out possible
Turalio pexidartinib hydrochloride	pexidartinib hydrochloride	Daiichi Sankyo Inc	211810	24 Jul 2038	patent
Tryvio aprocitentan	aprocitentan	Idorsia	217686	26 Jul 2038	patent, carve-out possible

Aug 2038 · 8

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Voydeya · 2 strengths danicopan	danicopan	Alexion Pharms Inc	218037	2 Aug 2038	patent, carve-out possible
Bixlenvo bictegravir sodium; lenacapavir sodium	bictegravir sodium; lenacapavir sodium	Gilead Sciences Inc	221104	16 Aug 2038	patent
Bixlenvo Sunlenca Starter Pack (Copackaged) bictegravir sodium, lenacapavir sodium; lenacapavir sodium	bictegravir sodium, lenacapavir sodium; lenacapavir sodium	Gilead Sciences Inc	221443	16 Aug 2038	patent
Yeztugo lenacapavir sodium	lenacapavir sodium	Gilead Sciences Inc	220020	16 Aug 2038	patent
Zonisade zonisamide	zonisamide	Azurity	214273	18 Aug 2038	patent
Altreno tretinoin	tretinoin	Dow Pharm	209353	22 Aug 2038	patent
Korlym mifepristone	mifepristone	Corcept Therap	202107	22 Aug 2038	patent, carve-out possible
Gocovri · 2 strengths amantadine hydrochloride	amantadine hydrochloride	Supernus Pharms	208944	23 Aug 2038	patent

Sep 2038 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Juluca dolutegravir sodium; rilpivirine hydrochloride	dolutegravir sodium; rilpivirine hydrochloride	Viiv Hlthcare	210192	5 Sep 2038	patent
Klisyri tirbanibulin	tirbanibulin	Almirall	213189	7 Sep 2038	patent
Redemplo plozasiran sodium	plozasiran sodium	Arrowhead	219947	10 Sep 2038	patent
Austedo · 3 strengths deutetrabenazine	deutetrabenazine	Teva Branded Pharm	208082	15 Sep 2038	patent
Opfolda miglustat	miglustat	Amicus Therap Us	215211	16 Sep 2038	patent, carve-out possible
Zeposia · 3 strengths ozanimod hydrochloride	ozanimod hydrochloride	Bristol	209899	30 Sep 2038	patent

Oct 2038 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Lorbrena · 2 strengths lorlatinib	lorlatinib	Pfizer	210868	4 Oct 2038	patent
Breztri Aerosphere · 2 strengths budesonide; formoterol fumarate; glycopyrrolate	budesonide; formoterol fumarate; glycopyrrolate	Astrazeneca Ab	212122	5 Oct 2038	patent
Ozempic · 3 strengths semaglutide	semaglutide	Novo	209637	10 Oct 2038	patent, carve-out possible
Rivfloza · 3 strengths nedosiran sodium	nedosiran sodium	Novo	215842	12 Oct 2038	patent
Jascayd · 2 strengths nerandomilast	nerandomilast	Boehringer Ingelheim	218764	22 Oct 2038	patent, carve-out possible
Ferriprox deferiprone	deferiprone	Chiesi	212269	25 Oct 2038	patent

Nov 2038 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Alvaiz · 4 strengths eltrombopag choline	eltrombopag choline	Teva Pharms Inc	216774	5 Nov 2038	patent
Inlexzo gemcitabine hydrochloride	gemcitabine hydrochloride	Janssen Biotech	219683	7 Nov 2038	patent, carve-out possible
Thiola Ec · 2 strengths tiopronin	tiopronin	Mission Pharmacal	211843	14 Nov 2038	patent, carve-out possible
Lenvima · 2 strengths lenvatinib mesylate	lenvatinib mesylate	Eisai Inc	206947	15 Nov 2038	patent
Gimoti metoclopramide hydrochloride	metoclopramide hydrochloride	Qol Medcl	209388	17 Nov 2038	patent, carve-out possible

Dec 2038 · 8

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Xolremdi mavorixafor	mavorixafor	X4 Pharms	218709	11 Dec 2038	patent
Cerdelga eliglustat tartrate	eliglustat tartrate	Genzyme Corp	205494	13 Dec 2038	patent, carve-out possible
Empaveli pegcetacoplan	pegcetacoplan	Apellis Pharms	215014	14 Dec 2038	patent
Syfovre pegcetacoplan	pegcetacoplan	Apellis Pharms	217171	14 Dec 2038	patent
Xdemvy lotilaner	lotilaner	Tarsus	217603	14 Dec 2038	patent
Tadliq tadalafil	tadalafil	Cmp Dev Llc	214522	24 Dec 2038	patent
Fintepla fenfluramine hydrochloride	fenfluramine hydrochloride	Ucb Inc	212102	29 Dec 2038	patent
Tafinlar dabrafenib mesylate	dabrafenib mesylate	Novartis	217514	29 Dec 2038	patent