risperidone · Teva · NDA 213586
Uzedy
Earliest generic entry, as listed · earliest of 7 marketed strengths
17 Mar 2042
Blocked by patent: US 12329851. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
9 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12329851 | use U-4214 · sets the listed date | 17 Mar 2042 |
| US 12128132 | drug product, use U-543, U-601 | 11 Sep 2040 |
| US 12128132 listing row | drug product, use U-543 | 11 Sep 2040 |
| US 12128132 listing row | drug product, use U-601 | 11 Sep 2040 |
| US 12383493 | drug product, use U-543, U-601 | 11 Sep 2040 |
| US 12383493 listing row | drug product, use U-543 | 11 Sep 2040 |
| US 12383493 listing row | drug product, use U-601 | 11 Sep 2040 |
| US 9023897 | drug product | 5 Apr 2033 |
| US 8221778 | drug product, use U-543, U-601 | 12 Nov 2027 |
| US 8221778 listing row | drug product, use U-543 | 12 Nov 2027 |
| US 8221778 listing row | drug product, use U-601 | 12 Nov 2027 |
| US 8741327 | drug product, use U-543 | 12 Nov 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213586 · 001 · RLD | suspension, extended release, subcutaneous | 50MG/0.14ML (50MG/0.14ML) | 17 Mar 2042 |
| 213586 · 002 · RLD | suspension, extended release, subcutaneous | 75MG/0.21ML (75MG/0.21ML) | 17 Mar 2042 |
| 213586 · 003 · RLD | suspension, extended release, subcutaneous | 100MG/0.28ML (100MG/0.28ML) | 17 Mar 2042 |
| 213586 · 004 · RLD | suspension, extended release, subcutaneous | 125MG/0.35ML (125MG/0.35ML) | 17 Mar 2042 |
| 213586 · 005 · RLD | suspension, extended release, subcutaneous | 150MG/0.42ML (150MG/0.42ML) | 17 Mar 2042 |
| 213586 · 006 · RLD | suspension, extended release, subcutaneous | 200MG/0.56ML (200MG/0.56ML) | 17 Mar 2042 |
| 213586 · 007 · RLD | suspension, extended release, subcutaneous | 250MG/0.7ML (250MG/0.7ML) | 17 Mar 2042 |
Expired or delisted (1)
- NP · 28 Apr 2026