82 drugs reach their earliest generic-entry date in 2031

Jan 2031 · 7

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Gilotrif · 3 strengths afatinib dimaleate	afatinib dimaleate	Boehringer Ingelheim	201292	5 Jan 2031	patent
Besivance besifloxacin hydrochloride	besifloxacin hydrochloride	Bausch And Lomb	022308	9 Jan 2031	patent
Pliaglis lidocaine; tetracaine	lidocaine; tetracaine	Crescita Therap	021717	14 Jan 2031	patent
Zypitamag · 2 strengths pitavastatin magnesium	pitavastatin magnesium	Medicure	208379	19 Jan 2031	patent
Jelmyto mitomycin	mitomycin	Urogen Pharma	211728	20 Jan 2031	patent
Dovato dolutegravir sodium; lamivudine	dolutegravir sodium; lamivudine	Viiv Hlthcare	211994	24 Jan 2031	patent
Invega Sustenna · 5 strengths paliperidone palmitate	paliperidone palmitate	Janssen Pharms	022264	26 Jan 2031	patent, carve-out possible

Feb 2031 · 10

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Uptravi selexipag	selexipag	Actelion	214275	1 Feb 2031	patent
Vocabria cabotegravir sodium	cabotegravir sodium	Viiv Hlthcare	212887	4 Feb 2031	patent
Lupron Depot leuprolide acetate	leuprolide acetate	Abbvie Endocrine Inc	020517	5 Feb 2031	patent
Lupron Depot-Ped Kit leuprolide acetate	leuprolide acetate	Abbvie Endocrine Inc	020263	5 Feb 2031	patent
Teflaro · 2 strengths ceftaroline fosamil	ceftaroline fosamil	Abbvie	200327	10 Feb 2031	patent
Idose Tr travoprost	travoprost	Glaukos	218010	14 Feb 2031	patent
Quillivant Xr methylphenidate hydrochloride	methylphenidate hydrochloride	Nextwave	202100	15 Feb 2031	patent
Technegas Kit technetium tc-99m labeled carbon	technetium tc-99m labeled carbon	Cyclomedica	022335	24 Feb 2031	patent, carve-out possible
Edluar · 2 strengths zolpidem tartrate	zolpidem tartrate	Viatris	021997	25 Feb 2031	patent, carve-out possible
Xermelo telotristat etiprate	telotristat etiprate	Tersera	208794	28 Feb 2031	patent

Mar 2031 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Relistor methylnaltrexone bromide	methylnaltrexone bromide	Salix	208271	10 Mar 2031	patent
Bevespi Aerosphere formoterol fumarate; glycopyrrolate	formoterol fumarate; glycopyrrolate	Astrazeneca	208294	17 Mar 2031	patent, carve-out possible
Intrarosa prasterone	prasterone	Millicent	208470	19 Mar 2031	patent
Xadago · 2 strengths safinamide mesylate	safinamide mesylate	Mdd Us	207145	21 Mar 2031	patent, carve-out possible
Sodium Thiosulfate sodium thiosulfate	sodium thiosulfate	Hope Pharms	203923	29 Mar 2031	patent

Apr 2031 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Breo Ellipta · 3 strengths fluticasone furoate; vilanterol trifenatate	fluticasone furoate; vilanterol trifenatate	Glaxo Grp Ltd	204275	11 Apr 2031	patent
Trelegy Ellipta · 2 strengths fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	Glaxosmithkline	209482	11 Apr 2031	patent
Mekinist trametinib dimethyl sulfoxide	trametinib dimethyl sulfoxide	Novartis	217513	15 Apr 2031	patent
Spiriva Respimat tiotropium bromide	tiotropium bromide	Boehringer Ingelheim	021936	16 Apr 2031	patent
Treanda · 2 strengths bendamustine hydrochloride	bendamustine hydrochloride	Cephalon	022249	26 Apr 2031	patent
Jevtana Kit cabazitaxel	cabazitaxel	Sanofi Aventis Us	201023	27 Apr 2031	patent

May 2031 · 2

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Ztlido lidocaine	lidocaine	Scilex Pharms	207962	10 May 2031	patent
Xigduo Xr · 5 strengths dapagliflozin; metformin hydrochloride	dapagliflozin; metformin hydrochloride	Astrazeneca Ab	205649	12 May 2031	patent

Jun 2031 · 10

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Cresemba · 2 strengths isavuconazonium sulfate	isavuconazonium sulfate	Astellas	207500	8 Jun 2031	exclusivity
Cresemba isavuconazonium sulfate	isavuconazonium sulfate	Astellas	207501	8 Jun 2031	exclusivity
Orkambi · 3 strengths ivacaftor; lumacaftor	ivacaftor; lumacaftor	Vertex Pharms Inc	211358	11 Jun 2031	patent
Orkambi · 2 strengths ivacaftor; lumacaftor	ivacaftor; lumacaftor	Vertex Pharms Inc	206038	11 Jun 2031	patent
Sovaldi · 2 strengths sofosbuvir	sofosbuvir	Gilead Sciences Inc	204671	11 Jun 2031	patent
Sovaldi · 2 strengths sofosbuvir	sofosbuvir	Gilead Sciences Inc	212480	11 Jun 2031	patent
Mirvaso brimonidine tartrate	brimonidine tartrate	Galderma Labs Lp	204708	13 Jun 2031	patent
Baxdela delafloxacin meglumine	delafloxacin meglumine	Melinta	208610	19 Jun 2031	patent
Slynd drospirenone	drospirenone	Exeltis Usa Inc	211367	28 Jun 2031	patent
Multaq dronedarone hydrochloride	dronedarone hydrochloride	Sanofi Aventis Us	022425	30 Jun 2031	patent, carve-out possible

Jul 2031 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Edarbyclor · 2 strengths azilsartan kamedoxomil; chlorthalidone	azilsartan kamedoxomil; chlorthalidone	Azurity	202331	1 Jul 2031	patent, carve-out possible
Iyuzeh latanoprost	latanoprost	Thea Pharma	216472	8 Jul 2031	patent
Revtorpyk gedatolisib	gedatolisib	Celcuity	219908	14 Jul 2031	exclusivity
Nerlynx neratinib maleate	neratinib maleate	Puma Biotech	208051	18 Jul 2031	patent, carve-out possible
Tosymra sumatriptan	sumatriptan	Tonix Meds	210884	19 Jul 2031	patent
Pradaxa · 3 strengths dabigatran etexilate mesylate	dabigatran etexilate mesylate	Boehringer Ingelheim	022512	20 Jul 2031	patent

Aug 2031 · 10

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Zilretta triamcinolone acetonide	triamcinolone acetonide	Pacira Pharms Inc	208845	4 Aug 2031	patent
Thyquidity levothyroxine sodium	levothyroxine sodium	Stevens J	214047	6 Aug 2031	patent
Ecoza econazole nitrate	econazole nitrate	Resilia Pharms	205175	8 Aug 2031	patent
Belrapzo bendamustine hydrochloride	bendamustine hydrochloride	Eagle Pharms	205580	11 Aug 2031	patent
Orenitram · 5 strengths treprostinil diolamine	treprostinil diolamine	United Therap	203496	11 Aug 2031	patent
Pretomanid pretomanid	pretomanid	Mylan Ireland Ltd	212862	14 Aug 2031	exclusivity
Eliquis · 3 strengths apixaban	apixaban	Bristol Myers Squibb	202155	24 Aug 2031	patent
Winlevi clascoterone	clascoterone	Sun Pharm	213433	26 Aug 2031	patent
Prevymis · 2 strengths letermovir	letermovir	Msd	219104	30 Aug 2031	exclusivity
Prevymis · 2 strengths letermovir	letermovir	Merck Sharp Dohme	209939	30 Aug 2031	exclusivity

Sep 2031 · 9

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Tpoxx tecovirimat	tecovirimat	Siga Technologies	214518	4 Sep 2031	patent, carve-out possible
Uceris budesonide	budesonide	Salix	203634	7 Sep 2031	patent
Uloric · 2 strengths febuxostat	febuxostat	Takeda Pharms Usa	021856	8 Sep 2031	patent, carve-out possible
Pixclara floretyrosine f-18	floretyrosine f-18	Telix	218592	11 Sep 2031	exclusivity
Apretude cabotegravir	cabotegravir	Viiv Hlthcare	215499	15 Sep 2031	patent
Anzupgo delgocitinib	delgocitinib	Leo Pharma As	219155	19 Sep 2031	patent
Opsynvi · 2 strengths macitentan; tadalafil	macitentan; tadalafil	Actelion	218490	22 Sep 2031	exclusivity
Verzenio · 4 strengths abemaciclib	abemaciclib	Eli Lilly And Co	208716	28 Sep 2031	patent
Mulpleta lusutrombopag	lusutrombopag	Vancocin Italia	210923	29 Sep 2031	patent

Oct 2031 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Cleviprex · 2 strengths clevidipine	clevidipine	Chiesi	022156	10 Oct 2031	patent
Letairis · 2 strengths ambrisentan	ambrisentan	Gilead	022081	14 Oct 2031	patent, carve-out possible
Qnasl · 2 strengths beclomethasone dipropionate	beclomethasone dipropionate	Teva Branded Pharm	202813	21 Oct 2031	patent
Angeliq drospirenone; estradiol	drospirenone; estradiol	Bayer Hlthcare	021355	22 Oct 2031	patent
Mytesi crofelemer	crofelemer	Napo Pharms Inc	202292	31 Oct 2031	patent, carve-out possible

Nov 2031 · 2

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Bryhali halobetasol propionate	halobetasol propionate	Bausch	209355	2 Nov 2031	patent
Latuda · 5 strengths lurasidone hydrochloride	lurasidone hydrochloride	Sunovion Pharms Inc	200603	23 Nov 2031	patent

Dec 2031 · 10

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Keppra · 4 strengths levetiracetam	levetiracetam	Ucb Inc	021035	7 Dec 2031	patent
Enstilar betamethasone dipropionate; calcipotriene	betamethasone dipropionate; calcipotriene	Leo Pharma As	207589	10 Dec 2031	patent
Segluromet · 4 strengths ertugliflozin; metformin hydrochloride	ertugliflozin; metformin hydrochloride	Msd Sub Merck	209806	19 Dec 2031	patent
Steglatro · 2 strengths ertugliflozin	ertugliflozin	Msd Sub Merck	209803	19 Dec 2031	patent
Steglujan · 2 strengths ertugliflozin; sitagliptin phosphate	ertugliflozin; sitagliptin phosphate	Msd Sub Merck	209805	19 Dec 2031	patent
Hysingla Er · 6 strengths hydrocodone bitartrate	hydrocodone bitartrate	Knoa Pharma	206627	21 Dec 2031	patent
Pomalyst · 4 strengths pomalidomide	pomalidomide	Bristol	204026	21 Dec 2031	patent
Nithiodote sodium nitrite; sodium thiosulfate	sodium nitrite; sodium thiosulfate	Hope Pharms	201444	24 Dec 2031	patent
Sodium Nitrite sodium nitrite	sodium nitrite	Hope Pharms	203922	24 Dec 2031	patent
Fanapt · 7 strengths iloperidone	iloperidone	Vanda Pharms Inc	022192	28 Dec 2031	patent, carve-out possible