ezetimibe; rosuvastatin calcium · Althera Pharms · NDA 213072
Roszet
Earliest generic entry, as listed · earliest of 4 marketed strengths
1 May 2033
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10376470, US 9763885.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10376470 | drug product, use U-3095 · sets the listed date | 1 May 2033 |
| US 9763885 | drug product, use U-3095 · sets the listed date | 1 May 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213072 · 001 · RLD · discontinued | tablet, oral | 10MG;EQ 5MG BASE | 1 May 2033 |
| 213072 · 002 · RLD · discontinued | tablet, oral | 10MG;EQ 10MG BASE | 1 May 2033 |
| 213072 · 003 · RLD · discontinued | tablet, oral | 10MG;EQ 20MG BASE | 1 May 2033 |
| 213072 · 004 · RLD · discontinued | tablet, oral | 10MG;EQ 40MG BASE | 1 May 2033 |