Applicant, as named in the Orange Book

Ptc Therap

Next listed expiry: Sephience on 6 Mar 2042. 1 products with live protection, 2 without.

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis
Sephience NDA 219666 · 2 strengths sepiapterin	sepiapterin	6 Mar 2042 patent, carve-out possible	patent, carve-out possible

Emflaza · Generic approved · ANDA 220042, Zydus LifesciencesApproved 3 Oct 2025Detected 25 Oct 2026
Emflaza · Generic approved · ANDA 217173, AmnealApproved 12 Dec 2025Detected 25 Oct 2026
Emflaza · Generic approved · ANDA 217103, Teva Pharms IncApproved 19 Oct 2026Detected 25 Oct 2026
Emflaza · Generic approved · ANDA 219930, Sun Pharm Inds IncApproved 27 Jan 2026Detected 25 Oct 2026
Emflaza · Generic approved · ANDA 220709, Biocon PharmaApproved 28 May 2026Detected 25 Oct 2026
Emflaza · Generic approved · ANDA 220524, HikmaApproved 18 Sep 2026Detected 25 Oct 2026

Products without listed protection (2)

Drug	Ingredient	Earliest generic entry	Basis
Emflaza NDA 208684 · 4 strengths deflazacort	deflazacort	open now no listed protection	no listed protection
Emflaza NDA 208685 deflazacort	deflazacort	open now no listed protection	no listed protection