azilsartan kamedoxomil; chlorthalidone · Azurity · NDA 202331
Edarbyclor
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Jul 2031
Blocked by patent: US 9387249. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9387249 | use U-3 · sets the listed date | 1 Jul 2031 |
| US 9169238 | drug product | 4 Feb 2030 |
| US 9066936 | drug product | 26 Mar 2028 |
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 |
|---|---|---|---|
| 202331 · 001 · RLD | tablet, oral | EQ 40MG MEDOXOMIL;12.5MG | 1 Jul 2031 |
| 202331 · 002 · RLD | tablet, oral | EQ 40MG MEDOXOMIL;25MG | 1 Jul 2031 |