umbralisib tosylate · Tg Theraps · NDA 213176
Ukoniq
Earliest generic entry, as listed
26 May 2035
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10414773, US 10947244, US 9969740.
Listed patents · 8 unexpired
15 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10414773 | drug substance, drug product, use U-3063, U-3064 | 26 May 2035 |
| US 10414773 listing row | drug substance, drug product, use U-3063 · sets the listed date | 26 May 2035 |
| US 10414773 listing row | drug substance, drug product, use U-3064 · sets the listed date | 26 May 2035 |
| US 10947244 | use U-3063, U-3064 | 26 May 2035 |
| US 10947244 listing row | use U-3063 · sets the listed date | 26 May 2035 |
| US 10947244 listing row | use U-3064 · sets the listed date | 26 May 2035 |
| US 9969740 | drug substance, drug product, use U-3063, U-3064 | 26 May 2035 |
| US 9969740 listing row | drug substance, drug product, use U-3063 · sets the listed date | 26 May 2035 |
| US 9969740 listing row | drug substance, drug product, use U-3064 · sets the listed date | 26 May 2035 |
| US 10072013 | use U-3063, U-3064 | 2 Jul 2033 |
| US 10072013 listing row | use U-3063 | 2 Jul 2033 |
| US 10072013 listing row | use U-3064 | 2 Jul 2033 |
| US 10570142 | drug substance, drug product, use U-3063, U-3064 | 2 Jul 2033 |
| US 10570142 listing row | drug substance, drug product, use U-3063 | 2 Jul 2033 |
| US 10570142 listing row | drug substance, drug product, use U-3064 | 2 Jul 2033 |
| US 10981919 | use U-3063, U-3064 | 2 Jul 2033 |
| US 10981919 listing row | use U-3063 | 2 Jul 2033 |
| US 10981919 listing row | use U-3064 | 2 Jul 2033 |
| US 9150579 | drug substance, drug product | 2 Jul 2033 |
| US 9669033 | use U-3063, U-3064 | 2 Jul 2033 |
| US 9669033 listing row | use U-3063 | 2 Jul 2033 |
| US 9669033 listing row | use U-3064 | 2 Jul 2033 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213176 · 001 · RLD · discontinued | tablet, oral | EQ 200MG BASE | 26 May 2035 |
Expired or delisted (1)
- NCE · 5 Feb 2026