valbenazine tosylate · Neurocrine · NDA 209241
Ingrezza
Earliest generic entry, as listed · earliest of 3 marketed strengths
10 Aug 2040
Blocked by patent: US 10940141. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 22 unexpired
33 Orange Book listing rows for 22 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10940141 | use U-1995 · sets the listed date | 10 Aug 2040 |
| US 11026931 | use U-1995 | 14 Aug 2039 |
| US 11654142 | use U-3055 | 14 Nov 2038 |
| US 11026939 | drug product, use U-1995, U-3055 | 18 Sep 2038 |
| US 11026939 listing row | drug product, use U-1995 | 18 Sep 2038 |
| US 11026939 listing row | drug product, use U-3055 | 18 Sep 2038 |
| US 11311532 | drug product, use U-1995, U-3055 | 18 Sep 2038 |
| US 11311532 listing row | drug product, use U-1995 | 18 Sep 2038 |
| US 11311532 listing row | drug product, use U-3055 | 18 Sep 2038 |
| US 10857137 | use U-1995 | 10 Oct 2037 |
| US 10857148 | use U-1995 | 10 Oct 2037 |
| US 10874648 | use U-1995, U-3046, U-3055 | 10 Oct 2037 |
| US 10874648 listing row | use U-1995 | 10 Oct 2037 |
| US 10874648 listing row | use U-3046 | 10 Oct 2037 |
| US 10874648 listing row | use U-3055 | 10 Oct 2037 |
| US 10912771 | use U-1995, U-3055, U-3076 | 10 Oct 2037 |
| US 10912771 listing row | use U-1995 | 10 Oct 2037 |
| US 10912771 listing row | use U-3055 | 10 Oct 2037 |
| US 10912771 listing row | use U-3076 | 10 Oct 2037 |
| US 10952997 | use U-1995 | 10 Oct 2037 |
| US 10993941 | use U-1995 | 10 Oct 2037 |
| US 11040029 | use U-1995 | 10 Oct 2037 |
| US 11439629 | use U-3055 | 10 Oct 2037 |
| US 10906902 | drug substance, drug product | 22 Dec 2036 |
| US 10906903 | drug substance, drug product | 22 Dec 2036 |
| US 10919892 | drug substance, drug product | 22 Dec 2036 |
| US 10065952 | drug substance, drug product, use U-1995, U-3055 | 28 Oct 2036 |
| US 10065952 listing row | drug substance, drug product, use U-1995 | 28 Oct 2036 |
| US 10065952 listing row | drug substance, drug product, use U-3055 | 28 Oct 2036 |
| US 10844058 | drug substance, drug product, use U-1995, U-3055 | 28 Oct 2036 |
| US 10844058 listing row | drug substance, drug product, use U-1995 | 28 Oct 2036 |
| US 10844058 listing row | drug substance, drug product, use U-3055 | 28 Oct 2036 |
| US 10851103 | drug substance, drug product, use U-1995, U-3055 | 28 Oct 2036 |
| US 10851103 listing row | drug substance, drug product, use U-1995 | 28 Oct 2036 |
| US 10851103 listing row | drug substance, drug product, use U-3055 | 28 Oct 2036 |
| US 10851104 | drug substance, use U-1995, U-3055 | 28 Oct 2036 |
| US 10851104 listing row | drug substance, use U-1995 | 28 Oct 2036 |
| US 10851104 listing row | drug substance, use U-3055 | 28 Oct 2036 |
| US 8039627 | drug substance, drug product | 11 Apr 2031 |
| US 8357697 | use U-1995, U-3055 | 8 Nov 2027 |
| US 8357697 listing row | use U-1995 | 8 Nov 2027 |
| US 8357697 listing row | use U-3055 | 8 Nov 2027 |
Exclusivities · 1 unexpired
| ODE-440 | orphan drug (7 years) | 18 Aug 2030 |
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
- Generic tentatively approved · ANDA 215984, Teva Pharms Inc · 209241-001Tentative approval 21 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209241 · 001 · RLD | capsule, oral | EQ 40MG BASE | 10 Aug 2040 |
| 209241 · 002 · RLD | capsule, oral | EQ 80MG BASE | 10 Aug 2040 |
| 209241 · 003 · RLD | capsule, oral | EQ 60MG BASE | 10 Aug 2040 |
Expired or delisted (1)
- I-925 · 18 Aug 2026