Applicant, as named in the Orange Book

Am Regent

Next listed expiry: Injectafer on 15 Feb 2028. 4 products with live protection, 4 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Injectafer · 4 strengths ferric carboxymaltose	ferric carboxymaltose	203565	15 Feb 2028	patent, carve-out possible
Multrys cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	209376	1 Jul 2041	patent
Selenious Acid · 3 strengths selenious acid	selenious acid	209379	1 Jul 2041	patent
Tralement · 2 strengths cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	209376	1 Jul 2041	patent

Recent events

25 Oct 2026Selenious Acid · Generic approved 31 Dec 2025
25 Oct 2026Selenious Acid · Generic approved 3 Feb 2026
25 Oct 2026Selenious Acid · Generic approved 30 Jun 2026
25 Oct 2026Furosemide · Generic approved 8 Jan 2026
25 Oct 2026Injectafer · First generic approved 25 Jun 2026
25 Oct 2026Injectafer · Generic approved 25 Jun 2026
25 Oct 2026Injectafer · First generic approved 25 Jun 2026
25 Oct 2026Injectafer · Generic approved 25 Jun 2026
25 Oct 2026Injectafer · First generic approved 25 Jun 2026
25 Oct 2026Injectafer · Generic approved 25 Jun 2026

Products without listed protection (4)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Paclitaxel paclitaxel	paclitaxel	211875	open now	no listed protection
Vasopressin · 2 strengths vasopressin	vasopressin	212593	open now	no listed protection
Venofer · 3 strengths iron sucrose	iron sucrose	021135	open now	no listed protection
Zinc Sulfate · 3 strengths zinc sulfate	zinc sulfate	209377	open now	no listed protection