FDA Orange Book · active-ingredient family
Azilsartan kamedoxomil
Azilsartan kamedoxomil 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:EDARBI · NDA 200796
1
Brand (NDA)
1
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EDARBIRLD×2 | AZURITY | NDA 200796 | AB | Feb 25, 2011 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZILSARTAN MEDOXOMIL×2 | LUPIN | ANDA 214489 | AB | Jul 20, 2022 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9066936 | Mar 26, 2028 | in 1 yr 10 mo | Product |
Azilsartan kamedoxomil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
