vosoritide · Biomarin Pharm · NDA 214938
Voxzogo
Earliest generic entry, as listed · earliest of 3 marketed strengths
11 Jul 2042
Blocked by patent: US 12233106. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12233106 | use U-3927 | 11 Jul 2042 |
| US 10646550 | product, use U-3927 | 1 Aug 2036 |
| US 11590204 | product, use U-3927 | 1 Aug 2036 |
| US 11911446 | use U-3927 | 1 Aug 2036 |
| US 12514906 | product, use U-3927 | 1 Aug 2036 |
| US 9907834 | product | 1 Aug 2036 |
| US 8198242 | substance, product, use U-3927 | 11 Jun 2035 |
| US RE48267 | use U-3927 | 20 May 2030 |
Exclusivities · 3 unexpired
| ODE-449 | orphan drug (7 years) | 20 Oct 2030 |
| ODE-387 | orphan drug (7 years) | 19 Nov 2028 |
| NCE | new chemical entity (5 years) | 19 Nov 2026 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 24 Oct 2026Exclusivity expires within 90 days NCE · 214938-00319 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days NCE · 214938-00219 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days NCE · 214938-00119 Nov 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214938 · 001 · RLD | powder, subcutaneous | 0.4MG/VIAL | 11 Jul 2042 |
| 214938 · 002 · RLD | powder, subcutaneous | 0.56MG/VIAL | 11 Jul 2042 |
| 214938 · 003 · RLD | powder, subcutaneous | 1.2MG/VIAL | 11 Jul 2042 |
Expired or delisted (1)
- NPP · 20 Oct 2026