Applicant, as named in the Orange Book

Hikma

Next listed expiry: Mitigare on 22 Aug 2033. 7 products with live protection, 30 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Mitigare colchicine	colchicine	204820	22 Aug 2033	patent, carve-out possible
Kloxxado naloxone hydrochloride	naloxone hydrochloride	212045	26 Aug 2034	patent
Tyzavan · 7 strengths vancomycin hydrochloride	vancomycin hydrochloride	211962	6 Nov 2035	patent
Combogesic Iv acetaminophen; ibuprofen sodium	acetaminophen; ibuprofen sodium	215320	14 Jan 2036	patent
Immphentiv · 2 strengths phenylephrine hydrochloride	phenylephrine hydrochloride	203826	26 Sep 2036	patent
Daptomycin · 2 strengths daptomycin	daptomycin	217415	9 Jan 2043	patent
Hydromorphone Hydrochloride hydromorphone hydrochloride	hydromorphone hydrochloride	217812	10 Jan 2043	patent

Recent events

25 Oct 2026Morphine Sulfate · Generic approved 7 Jul 2026
25 Oct 2026Reglan · Generic approved 11 Sep 2026
25 Oct 2026Mitigare · Generic approved 17 Feb 2026
25 Oct 2026Xopenex · Generic approved 26 May 2026

Products without listed protection (30)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Acetaminophen acetaminophen	acetaminophen	206968	open now	no listed protection
Amicar aminocaproic acid	aminocaproic acid	015230	open now	no listed protection
Amicar · 2 strengths aminocaproic acid	aminocaproic acid	015197	open now	no listed protection
Ativan · 2 strengths lorazepam	lorazepam	018140	open now	no listed protection
Cafcit caffeine citrate	caffeine citrate	020793	open now	no listed protection
Cefazolin Sodium · 2 strengths cefazolin sodium	cefazolin sodium	216109	open now	no listed protection
Codeine Sulfate · 3 strengths codeine sulfate	codeine sulfate	022402	open now	no listed protection
Cyclophosphamide · 2 strengths cyclophosphamide	cyclophosphamide	203856	open now	no listed protection
Daptomycin daptomycin	daptomycin	209949	open now	no listed protection
Daunorubicin Hydrochloride daunorubicin hydrochloride	daunorubicin hydrochloride	050731	open now	no listed protection
Digoxin digoxin	digoxin	021648	open now	no listed protection
Dopram doxapram hydrochloride	doxapram hydrochloride	014879	open now	no listed protection
Duramorph Pf · 2 strengths morphine sulfate	morphine sulfate	018565	open now	no listed protection
Fentanyl Citrate fentanyl citrate	fentanyl citrate	019101	open now	no listed protection
Heparin Sodium · 3 strengths heparin sodium	heparin sodium	017037	open now	no listed protection
Infumorph · 2 strengths morphine sulfate	morphine sulfate	018565	open now	no listed protection
Labetalol Hydrochloride labetalol hydrochloride	labetalol hydrochloride	213330	open now	no listed protection
Labetalol Hydrochloride In Dextrose labetalol hydrochloride	labetalol hydrochloride	213330	open now	no listed protection
Labetalol Hydrochloride In Sodium Chloride · 3 strengths labetalol hydrochloride	labetalol hydrochloride	213330	open now	no listed protection
Lithium Carbonate · 3 strengths lithium carbonate	lithium carbonate	017812	open now	no listed protection
Lithium Carbonate lithium carbonate	lithium carbonate	018558	open now	no listed protection
Methadone Hydrochloride methadone hydrochloride	methadone hydrochloride	017058	open now	no listed protection
Morphine Sulfate · 2 strengths morphine sulfate	morphine sulfate	022207	open now	no listed protection
Morphine Sulfate · 3 strengths morphine sulfate	morphine sulfate	022195	open now	no listed protection
Oxytocin · 2 strengths oxytocin	oxytocin	018243	open now	no listed protection
Pamidronate Disodium · 2 strengths pamidronate disodium	pamidronate disodium	021113	open now	no listed protection
Pantoprazole Sodium pantoprazole sodium	pantoprazole sodium	209463	open now	no listed protection
Phenylephrine Hydrochloride · 3 strengths phenylephrine hydrochloride	phenylephrine hydrochloride	203826	open now	no listed protection
Robaxin methocarbamol	methocarbamol	011790	open now	no listed protection
Robinul glycopyrrolate	glycopyrrolate	017558	open now	no listed protection