FDA Orange Book · active-ingredient family
Azilsartan kamedoxomil; chlorthalidone
Azilsartan kamedoxomil; chlorthalidone is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EDARBYCLOR · NDA 202331
1
Brand (NDA)
1
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EDARBYCLORRLD×2 | AZURITY | NDA 202331 | AB | Dec 20, 2011 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE×2 | ALKEM LABS LTD | ANDA 217490 | AB | Jan 21, 2025 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9066936 | Mar 26, 2028 | in 1 yr 10 mo | Product |
| 9169238 | Feb 04, 2030 | in 3 yr 8 mo | Product |
| 9387249 | Jul 01, 2031 | in 5 yr 1 mo | U-3 |
Azilsartan kamedoxomil; chlorthalidone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
