FDA Orange Book
Generic for Edarbyclor
Edarbyclor contains azilsartan kamedoxomil and chlorthalidone. 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 Edarbyclor is azilsartan kamedoxomil and chlorthalidone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Edarbyclor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 40MG MEDOXOMIL;12.5MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | EQ 40MG MEDOXOMIL;25MG | Marketed (Rx) | AB | 1 | AB |
NDA 202331, 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 and chlorthalidone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 217490 | AB (A-rated, therapeutically equivalent) | January 21, 2025 | EQ 40MG MEDOXOMIL;12.5MG, EQ 40MG MEDOXOMIL;25MG |
Edarbyclor patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9066936 | March 26, 2028 | Drug product | None | 202331 |
| 9169238 | February 4, 2030 | Drug product | None | 202331 |
| 9387249 | July 1, 2031 | Method of use | U-3 | 202331 |
Edarbyclor NDC codes
Questions
Is there a generic for Edarbyclor?
Yes. The generic name for Edarbyclor is azilsartan kamedoxomil and chlorthalidone. 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 Edarbyclor?
The active ingredient in Edarbyclor is azilsartan kamedoxomil and chlorthalidone, per the FDA Orange Book.
When does the Edarbyclor patent expire?
The last patent listed for Edarbyclor in the Orange Book expires July 1, 2031. 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.