Applicant, as named in the Orange Book
Horizon
Next listed expiry: Procysbi on 16 Feb 2037. 2 products with live protection, 0 without.
Products with listed protection
| Drug | Ingredient | NDA | Earliest generic entry | Basis |
|---|
| Procysbi · 2 strengths cysteamine bitartrate | cysteamine bitartrate | 203389 | 16 Feb 2037 | patent |
| Procysbi · 2 strengths cysteamine bitartrate | cysteamine bitartrate | 213491 | 16 Feb 2037 | patent |
Recent events
- 25 Oct 2026Rayos · Generic approved 1 Oct 2025
- 25 Oct 2026Rayos · Generic approved 26 Jun 2026
- 24 Oct 2026Rayos · Enters 12-month window basis: patent, carve-out possible3 Aug 2027
- 24 Oct 2026Rayos · Enters 12-month window basis: patent, carve-out possible3 Aug 2027