Applicant, as named in the Orange Book

Chiesi

Next listed expiry: Cardene In 0.83% Sodium Chloride In Plastic Container on 26 Dec 2027. 11 products with live protection, 2 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Cardene In 0.83% Sodium Chloride In Plastic Container nicardipine hydrochloride	nicardipine hydrochloride	019734	26 Dec 2027	patent
Cardene In 0.86% Sodium Chloride In Plastic Container nicardipine hydrochloride	nicardipine hydrochloride	019734	26 Dec 2027	patent
Cardene In 4.8% Dextrose In Plastic Container nicardipine hydrochloride	nicardipine hydrochloride	019734	26 Dec 2027	patent
Ferriprox deferiprone	deferiprone	021825	30 Apr 2028	exclusivity
Ferriprox deferiprone	deferiprone	208030	26 Oct 2029	patent
Cleviprex · 2 strengths clevidipine	clevidipine	022156	10 Oct 2031	patent
Kengreal cangrelor	cangrelor	204958	10 Jul 2035	patent
Ferriprox deferiprone	deferiprone	212269	25 Oct 2038	patent
Filsuvez birch triterpenes	birch triterpenes	215064	4 Jan 2039	patent
Mycapssa octreotide acetate	octreotide acetate	208232	28 Dec 2040	patent, carve-out possible
Juxtapid · 5 strengths lomitapide mesylate	lomitapide mesylate	203858	29 Jul 2041	patent, carve-out possible

Recent events

25 Oct 2026Ferriprox · Generic approved 11 Dec 2025
25 Oct 2026Cardene In 4.8% Dextrose In Plastic Container · Generic approved 4 Aug 2026
25 Oct 2026Kengreal · Generic approved 4 Jun 2026
25 Oct 2026Cardene In 4.8% Dextrose In Plastic Container · Generic approved 22 Oct 2025
24 Oct 2026Juxtapid · Enters 12-month window basis: patent, carve-out possible19 Aug 2027

Products without listed protection (2)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Bethkis tobramycin	tobramycin	201820	open now	no listed protection
Cardene nicardipine hydrochloride	nicardipine hydrochloride	019734	open now	no listed protection