Applicant, as named in the Orange Book

Sun Pharm Inds Inc

Next listed expiry: Levulan on 12 Jan 2038. 3 products with live protection, 4 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Levulan aminolevulinic acid hydrochloride	aminolevulinic acid hydrochloride	020965	12 Jan 2038	patent, carve-out possible
Sezaby phenobarbital sodium	phenobarbital sodium	215910	7 Apr 2042	patent
Leqselvi deuruxolitinib phosphate	deuruxolitinib phosphate	217900	10 Oct 2044	patent, carve-out possible

Recent events

25 Oct 2026Lac-Hydrin · Generic approved 15 May 2026
25 Oct 2026Lac-Hydrin · Generic approved 12 Feb 2026
25 Oct 2026Absorica · Generic approved 7 Oct 2025
25 Oct 2026Absorica · Generic approved 10 Sep 2026

Products without listed protection (4)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Absorica · 6 strengths isotretinoin	isotretinoin	021951	open now	no listed protection
An-Sulfur Colloid technetium tc-99m sulfur colloid kit	technetium tc-99m sulfur colloid kit	017858	open now	no listed protection
Halog halcinonide	halcinonide	017823	open now	no listed protection
Halog halcinonide	halcinonide	017556	open now	no listed protection