68 drugs reach their earliest generic-entry date in 2028

Jan 2028 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Atelvia risedronate sodium	risedronate sodium	Apil	022560	9 Jan 2028	patent
Nayzilam midazolam	midazolam	Ucb Inc	211321	18 Jan 2028	patent
Carbaglu carglumic acid	carglumic acid	Recordati Rare	022562	22 Jan 2028	exclusivity
Nourianz · 2 strengths istradefylline	istradefylline	Kyowa Kirin	022075	28 Jan 2028	patent
Natazia dienogest; estradiol valerate	dienogest; estradiol valerate	Bayer Hlthcare	022252	30 Jan 2028	patent, carve-out possible
Dificid fidaxomicin	fidaxomicin	Cubist Pharms Llc	201699	31 Jan 2028	patent

Feb 2028 · 4

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Alvesco · 2 strengths ciclesonide	ciclesonide	Azurity	021658	1 Feb 2028	patent, carve-out possible
Omnaris ciclesonide	ciclesonide	Azurity	022004	1 Feb 2028	patent, carve-out possible
Onapgo apomorphine hydrochloride	apomorphine hydrochloride	Mdd Us	214056	3 Feb 2028	exclusivity
Injectafer · 4 strengths ferric carboxymaltose	ferric carboxymaltose	Am Regent	203565	15 Feb 2028	patent, carve-out possible

Mar 2028 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Revlimid · 6 strengths lenalidomide	lenalidomide	Bristol Myers Squibb	021880	8 Mar 2028	patent, carve-out possible
Zolinza vorinostat	vorinostat	Msd Sub Merck	021991	18 Mar 2028	patent, carve-out possible
Edarbi · 2 strengths azilsartan kamedoxomil	azilsartan kamedoxomil	Azurity	200796	26 Mar 2028	patent
Savaysa · 3 strengths edoxaban tosylate	edoxaban tosylate	Daiichi Sankyo Inc	206316	28 Mar 2028	patent
Vusion miconazole nitrate; white petrolatum; zinc oxide	miconazole nitrate; white petrolatum; zinc oxide	Mylan	021026	30 Mar 2028	patent, carve-out possible

Apr 2028 · 4

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Trokendi Xr · 4 strengths topiramate	topiramate	Supernus Pharms	201635	4 Apr 2028	patent
Ferriprox deferiprone	deferiprone	Chiesi	021825	30 Apr 2028	exclusivity
Nicorette nicotine polacrilex	nicotine polacrilex	Haleon Us Holdings	020066	30 Apr 2028	patent
Nicorette nicotine polacrilex	nicotine polacrilex	Haleon Us Holdings	018612	30 Apr 2028	patent

May 2028 · 6

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Versacloz clozapine	clozapine	Douglas Pharms	203479	1 May 2028	patent
Sorilux calcipotriene	calcipotriene	Mayne Pharma	022563	7 May 2028	patent
Optison albumin human	albumin human	Ge Healthcare	020899	9 May 2028	exclusivity
Venlafaxine Besylate venlafaxine besylate	venlafaxine besylate	Almatica	215429	16 May 2028	patent
Dalvance dalbavancin hydrochloride	dalbavancin hydrochloride	Abbvie	021883	23 May 2028	patent, carve-out possible
Signifor Lar Kit · 5 strengths pasireotide pamoate	pasireotide pamoate	Recordati Rare	203255	23 May 2028	patent

Jun 2028 · 7

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Doral quazepam	quazepam	Galt Pharms	018708	3 Jun 2028	patent, carve-out possible
Astepro Allergy azelastine hydrochloride	azelastine hydrochloride	Bayer Hlthcare	213872	4 Jun 2028	patent
Children's Astepro Allergy azelastine hydrochloride	azelastine hydrochloride	Bayer Hlthcare	213872	4 Jun 2028	patent
Canasa mesalamine	mesalamine	Abbvie	021252	6 Jun 2028	patent
Duetact · 2 strengths glimepiride; pioglitazone hydrochloride	glimepiride; pioglitazone hydrochloride	Takeda Pharms Usa	021925	8 Jun 2028	patent
Bridion · 2 strengths sugammadex sodium	sugammadex sodium	Msd Sub Merck	022225	12 Jun 2028	exclusivity
Vyondys 53 golodirsen	golodirsen	Sarepta Theraps Inc	211970	28 Jun 2028	patent

Jul 2028 · 8

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Afinitor · 4 strengths everolimus	everolimus	Novartis	022334	1 Jul 2028	patent, carve-out possible
Yondelis trabectedin	trabectedin	Janssen Prods	207953	7 Jul 2028	patent
Osphena ospemifene	ospemifene	Duchesnay	203505	9 Jul 2028	patent
Motegrity · 2 strengths prucalopride succinate	prucalopride succinate	Takeda Pharms Usa	210166	10 Jul 2028	exclusivity
Fexinidazole fexinidazole	fexinidazole	Sanofi	214429	16 Jul 2028	exclusivity
Prograf · 2 strengths tacrolimus	tacrolimus	Astellas	210115	16 Jul 2028	exclusivity
Prograf · 3 strengths tacrolimus	tacrolimus	Astellas	050708	16 Jul 2028	exclusivity
Prograf tacrolimus	tacrolimus	Astellas	050709	16 Jul 2028	exclusivity

Aug 2028 · 8

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Tobradex St dexamethasone; tobramycin	dexamethasone; tobramycin	Harrow Eye	050818	3 Aug 2028	patent
Reclast zoledronic acid	zoledronic acid	Sandoz	021817	5 Aug 2028	patent
Caprelsa · 2 strengths vandetanib	vandetanib	Genzyme Corp	022405	8 Aug 2028	patent
Xeljanz tofacitinib citrate	tofacitinib citrate	Pfizer	213082	21 Aug 2028	exclusivity
Xeljanz tofacitinib citrate	tofacitinib citrate	Pf Prism Cv	203214	21 Aug 2028	exclusivity
Forfivo Xl bupropion hydrochloride	bupropion hydrochloride	Twi Pharms	022497	23 Aug 2028	patent
Twirla ethinyl estradiol; levonorgestrel	ethinyl estradiol; levonorgestrel	Agile	204017	26 Aug 2028	patent
Envarsus Xr · 3 strengths tacrolimus	tacrolimus	Veloxis Pharms Inc	206406	30 Aug 2028	patent

Sep 2028 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Topicort desoximetasone	desoximetasone	Sun Pharma Canada	204141	1 Sep 2028	patent
Nexavar sorafenib tosylate	sorafenib tosylate	Bayer Hlthcare	021923	10 Sep 2028	patent
Stiolto Respimat olodaterol hydrochloride; tiotropium bromide	olodaterol hydrochloride; tiotropium bromide	Boehringer Ingelheim	206756	13 Sep 2028	patent
Vizamyl flutemetamol f-18	flutemetamol f-18	Ge Healthcare	203137	16 Sep 2028	patent
Keppra Xr · 2 strengths levetiracetam	levetiracetam	Ucb Inc	022285	17 Sep 2028	patent

Oct 2028 · 8

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Isovue-200 iopamidol	iopamidol	Bracco	018735	10 Oct 2028	exclusivity
Isovue-250 iopamidol	iopamidol	Bracco	018735	10 Oct 2028	exclusivity
Isovue-300 iopamidol	iopamidol	Bracco	018735	10 Oct 2028	exclusivity
Isovue-370 iopamidol	iopamidol	Bracco	018735	10 Oct 2028	exclusivity
Flonase Sensimist Allergy Relief fluticasone furoate	fluticasone furoate	Haleon Us Holdings	022051	15 Oct 2028	patent
Ferabright · 2 strengths ferumoxytol	ferumoxytol	Azurity	219868	16 Oct 2028	exclusivity
Hemangeol propranolol hydrochloride	propranolol hydrochloride	Eton	205410	16 Oct 2028	patent, carve-out possible
Epioxa Hd/Epioxa Kit riboflavin 5'-phosphate sodium	riboflavin 5'-phosphate sodium	Glaukos	219910	17 Oct 2028	exclusivity

Nov 2028 · 2

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Iluvien fluocinolone acetonide	fluocinolone acetonide	Alimera Sciences Inc	201923	7 Nov 2028	patent
Bondlido lidocaine	lidocaine	Medrx Usa	215029	10 Nov 2028	patent

Dec 2028 · 5

Drug	Ingredient	Applicant	NDA	Earliest generic entry	Basis
Seasonique ethinyl estradiol; levonorgestrel	ethinyl estradiol; levonorgestrel	Teva Branded Pharm	021840	5 Dec 2028	patent, carve-out possible
Addyi flibanserin	flibanserin	Sprout Pharms	022526	13 Dec 2028	exclusivity
Suprax cefixime	cefixime	Lupin Ltd	202091	14 Dec 2028	patent
Erivedge vismodegib	vismodegib	Genentech	203388	15 Dec 2028	patent, carve-out possible
Rytary · 4 strengths carbidopa; levodopa	carbidopa; levodopa	Impax	203312	26 Dec 2028	patent