FDA Orange Book
Generic for Edarbi
Edarbi contains azilsartan kamedoxomil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Edarbi is azilsartan kamedoxomil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Edarbi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 40MG MEDOXOMIL | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | EQ 80MG MEDOXOMIL | Marketed (Rx) | AB | 1 | AB |
NDA 200796, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic azilsartan kamedoxomil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 214489 | AB (A-rated, therapeutically equivalent) | July 20, 2022 | EQ 40MG MEDOXOMIL, EQ 80MG MEDOXOMIL |
Edarbi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9066936 | March 26, 2028 | Drug product | None | 200796 |
Edarbi NDC codes
Questions
Is there a generic for Edarbi?
Yes. The generic name for Edarbi is azilsartan kamedoxomil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Edarbi?
The active ingredient in Edarbi is azilsartan kamedoxomil, per the FDA Orange Book.
When does the Edarbi patent expire?
The last patent listed for Edarbi in the Orange Book expires March 26, 2028. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.