obeticholic acid · Intercept · NDA 207999
Ocaliva
Earliest generic entry, as listed · earliest of 2 marketed strengths
26 Apr 2036
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10052337, US 10751349, US 10758549.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10052337 | drug product · sets the listed date | 26 Apr 2036 |
| US 10751349 | drug product · sets the listed date | 26 Apr 2036 |
| US 10758549 | use U-2945 · sets the listed date | 26 Apr 2036 |
| US 10047117 | use U-1854 | 6 Sep 2033 |
| US 10174073 | drug substance | 17 Jun 2033 |
| US 9238673 | drug product | 17 Jun 2033 |
| US RE48286 | drug substance, drug product | 21 Feb 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207999 · 001 · RLD · discontinued | tablet, oral | 5MG | 26 Apr 2036 |
| 207999 · 002 · RLD · discontinued | tablet, oral | 10MG | 26 Apr 2036 |