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 | NDA | Earliest generic entry | Basis |
|---|
| Sephience · 2 strengths sepiapterin | sepiapterin | 219666 | 6 Mar 2042 | patent, carve-out possible |
Recent events
- 25 Oct 2026Emflaza · Generic approved 3 Oct 2025
- 25 Oct 2026Emflaza · Generic approved 12 Dec 2025
- 25 Oct 2026Emflaza · Generic approved 19 Oct 2026
- 25 Oct 2026Emflaza · Generic approved 27 Jan 2026
- 25 Oct 2026Emflaza · Generic approved 28 May 2026
- 25 Oct 2026Emflaza · Generic approved 18 Sep 2026
Products without listed protection (2)
| Drug | Ingredient | NDA | Earliest generic entry | Basis |
|---|
| Emflaza · 4 strengths deflazacort | deflazacort | 208684 | open now | no listed protection |
| Emflaza deflazacort | deflazacort | 208685 | open now | no listed protection |