Applicant, as named in the Orange Book

Azurity

Next listed expiry: Suprep Bowel Prep Kit on 5 Aug 2027. 29 products with live protection, 15 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Suprep Bowel Prep Kit magnesium sulfate; potassium sulfate; sodium sulfate	magnesium sulfate; potassium sulfate; sodium sulfate	022372	5 Aug 2027	exclusivity
Alvesco · 2 strengths ciclesonide	ciclesonide	021658	1 Feb 2028	patent, carve-out possible
Omnaris ciclesonide	ciclesonide	022004	1 Feb 2028	patent, carve-out possible
Edarbi · 2 strengths azilsartan kamedoxomil	azilsartan kamedoxomil	200796	26 Mar 2028	patent
Ferabright · 2 strengths ferumoxytol	ferumoxytol	219868	16 Oct 2028	exclusivity
Tudorza Pressair aclidinium bromide	aclidinium bromide	202450	13 Mar 2029	patent
Horizant · 2 strengths gabapentin enacarbil	gabapentin enacarbil	022399	10 Jun 2029	patent
Triptodur Kit triptorelin pamoate	triptorelin pamoate	208956	30 Jun 2029	patent
Edarbyclor · 2 strengths azilsartan kamedoxomil; chlorthalidone	azilsartan kamedoxomil; chlorthalidone	202331	1 Jul 2031	patent, carve-out possible
Xatmep methotrexate sodium	methotrexate sodium	208400	2 Jan 2033	patent
Contrave bupropion hydrochloride; naltrexone hydrochloride	bupropion hydrochloride; naltrexone hydrochloride	200063	2 Jul 2034	patent, carve-out possible
Firvanq Kit · 2 strengths vancomycin hydrochloride	vancomycin hydrochloride	208910	13 Mar 2035	patent
Sotylize sotalol hydrochloride	sotalol hydrochloride	205108	31 Aug 2035	patent
Qbrelis lisinopril	lisinopril	208401	6 Nov 2035	patent
Epaned enalapril maleate	enalapril maleate	208686	25 Mar 2036	patent
Sutab magnesium sulfate; potassium chloride; sodium sulfate	magnesium sulfate; potassium chloride; sodium sulfate	213135	4 Aug 2037	patent
Fleqsuvy baclofen	baclofen	215602	29 Sep 2037	patent
Nymalize nimodipine	nimodipine	203340	16 Apr 2038	patent
Zonisade zonisamide	zonisamide	214273	18 Aug 2038	patent
Katerzia amlodipine benzoate	amlodipine benzoate	211340	11 Apr 2039	patent
Myhibbin mycophenolate mofetil	mycophenolate mofetil	216482	16 Aug 2039	patent
Danziten · 2 strengths nilotinib tartrate	nilotinib tartrate	219293	18 Feb 2040	patent
Konvomep omeprazole; sodium bicarbonate	omeprazole; sodium bicarbonate	213593	1 Mar 2040	patent, carve-out possible
Eprontia topiramate	topiramate	214679	21 Aug 2040	patent
Arynta lisdexamfetamine dimesylate	lisdexamfetamine dimesylate	219847	30 Aug 2040	patent
Javadin clonidine hydrochloride	clonidine hydrochloride	220256	15 Jul 2042	patent
Vivimusta bendamustine hydrochloride	bendamustine hydrochloride	212209	29 Jul 2042	patent
Suflave magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	215344	2 Aug 2044	patent
Lamlique · 2 strengths lamotrigine hemifumarate	lamotrigine hemifumarate	221109	14 Feb 2045	patent

Recent events

25 Oct 2026Azmiro · First generic approved 3 Sep 2026
25 Oct 2026Azmiro · Generic approved 3 Sep 2026
25 Oct 2026Suprep Bowel Prep Kit · Generic approved 31 Aug 2026
25 Oct 2026Qbrelis · First generic approved 20 Aug 2026
25 Oct 2026Qbrelis · Generic approved 20 Aug 2026
25 Oct 2026Gleostine · First generic approved 27 Oct 2025
25 Oct 2026Gleostine · Generic approved 27 Oct 2025
25 Oct 2026Horizant · Generic tentatively approved 20 Mar 2026
25 Oct 2026Konvomep · Generic approved 10 Dec 2025
25 Oct 2026Pce · First generic approved 23 Sep 2025
25 Oct 2026Pce · Generic approved 23 Sep 2025
25 Oct 2026Sutab · First generic approved 28 May 2026
25 Oct 2026Sutab · Generic approved 28 May 2026
25 Oct 2026Firvanq Kit · Generic approved 7 Aug 2026
24 Oct 2026Suprep Bowel Prep Kit · Enters 12-month window basis: exclusivity5 Aug 2027

Products without listed protection (15)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Aprepitant aprepitant	aprepitant	218754	open now	no listed protection
Bidil hydralazine hydrochloride; isosorbide dinitrate	hydralazine hydrochloride; isosorbide dinitrate	020727	open now	no listed protection
Feraheme ferumoxytol	ferumoxytol	022180	open now	no listed protection
Gleostine · 3 strengths lomustine	lomustine	017588	open now	no listed protection
Gliadel carmustine	carmustine	020637	open now	no listed protection
Golytely polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	019011	open now	no listed protection
Lanoxin digoxin	digoxin	009330	open now	no listed protection
Lanoxin Pediatric digoxin	digoxin	009330	open now	no listed protection
Nulytely polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	019797	open now	no listed protection
Nulytely-Flavored polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	019797	open now	no listed protection
Prilosec · 2 strengths omeprazole magnesium	omeprazole magnesium	022056	open now	no listed protection
Sular nisoldipine	nisoldipine	020356	open now	no listed protection
Treximet naproxen sodium; sumatriptan succinate	naproxen sodium; sumatriptan succinate	021926	open now	no listed protection
Verelan · 4 strengths verapamil hydrochloride	verapamil hydrochloride	019614	open now	no listed protection
Verelan Pm · 3 strengths verapamil hydrochloride	verapamil hydrochloride	020943	open now	no listed protection