Applicant, as named in the Orange Book

Recordati Rare

Part of Recordati

Company and ticker: cliffwatch mapping, checked against SEC EDGAR

Next listed expiry: Signifor on 14 Dec 2026. 5 products with live protection, 3 without.

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis
Signifor NDA 200677 · 3 strengths pasireotide diaspartate	pasireotide diaspartate	14 Dec 2026 patent	patent
Carbaglu NDA 022562 carglumic acid	carglumic acid	22 Jan 2028 exclusivity	exclusivity
Signifor Lar Kit NDA 203255 · 5 strengths pasireotide pamoate	pasireotide pamoate	23 May 2028 patent	patent
Neoprofen NDA 021903 ibuprofen lysine	ibuprofen lysine	2 Mar 2032 patent	patent
Isturisa NDA 212801 · 2 strengths osilodrostat phosphate	osilodrostat phosphate	12 Oct 2035 patent, carve-out possible	patent, carve-out possible

Recent events

Signifor · Enters 12-month window basis: patentListed date 14 Dec 2026Detected 24 Oct 2026
Signifor · Enters 12-month window basis: patentListed date 14 Dec 2026Detected 24 Oct 2026
Signifor · Enters 12-month window basis: patentListed date 14 Dec 2026Detected 24 Oct 2026

Products without listed protection (3)

Drug	Ingredient	Earliest generic entry	Basis
Chemet NDA 019998 succimer	succimer	open now no listed protection	no listed protection
Cystadane NDA 020576 betaine	betaine	open now no listed protection	no listed protection
Cystadrops NDA 211302 cysteamine hydrochloride	cysteamine hydrochloride	open now no listed protection	no listed protection