voxelotor · Global Blood Theraps · NDA 213137, 216157
Oxbryta
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 Dec 2036
Other strengths are listed to 12 Oct 2037; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11020382, US 11944612. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 11 unexpired
13 Orange Book listing rows for 11 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10493035 | drug product | 12 Oct 2037 |
| US 11020382 | use U-3133, U-3134 | 2 Dec 2036 |
| US 11020382 listing row | use U-3133 · sets the listed date | 2 Dec 2036 |
| US 11020382 listing row | use U-3134 · sets the listed date | 2 Dec 2036 |
| US 11944612 | use U-3893 · sets the listed date | 2 Dec 2036 |
| US 10722502 | drug product | 6 Feb 2035 |
| US 11452720 | use U-3459 | 6 Feb 2035 |
| US 9447071 | drug substance, drug product | 6 Feb 2035 |
| US 9248199 | use U-2676, U-2715 | 29 Jan 2034 |
| US 9248199 listing row | use U-2676 | 29 Jan 2034 |
| US 9248199 listing row | use U-2715 | 29 Jan 2034 |
| US 9018210 | drug substance, drug product | 25 Nov 2033 |
| US 10017491 | drug product | 28 Dec 2032 |
| US 10034879 | drug substance, drug product | 28 Dec 2032 |
| US 10806733 | drug substance | 28 Dec 2032 |
Exclusivities · 3 unexpired
| ODE-394 | orphan drug (7 years) | 17 Dec 2028 |
| ODE-281 | orphan drug (7 years) | 25 Nov 2026 |
| ODE* | 25 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 ODE-281 · 213137-00125 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days ODE* · 216157-00125 Nov 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213137 · 001 · RLD · discontinued | tablet, oral | 500MG | 12 Oct 2037 |
| 213137 · 002 · RLD · discontinued | tablet, oral | 300MG | 12 Oct 2037 |
| 216157 · 001 · RLD · discontinued | tablet, for suspension, oral | 300MG | 2 Dec 2036 |