FDA Orange Book
Is there a generic for Katerzia?
Katerzia contains amlodipine benzoate. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Katerzia (amlodipine benzoate). The Orange Book shows its last listed patent expires April 11, 2039.
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Katerzia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | EQ 1MG BASE/ML | Marketed (Rx) | None | 0 | None |
NDA 211340, 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.
Katerzia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10959991 | October 6, 2037 | Method of use | U-39 | 211340 |
| 10959991 | October 6, 2037 | Method of use | U-158 | 211340 |
| 10894039 | October 6, 2037 | Method of use | U-3 | 211340 |
| 10894039 | October 6, 2037 | Method of use | U-185 | 211340 |
| 11471409 | October 6, 2037 | Method of use | U-3447 | 211340 |
| 11471409 | October 6, 2037 | Method of use | U-3448 | 211340 |
| 12336984 | October 6, 2037 | Method of use | U-3447 | 211340 |
| 12336984 | October 6, 2037 | Method of use | U-3448 | 211340 |
| 11918685 | October 6, 2037 | Method of use | U-3447 | 211340 |
| 11918685 | October 6, 2037 | Method of use | U-3448 | 211340 |
| 11701326 | October 6, 2037 | Drug product | None | 211340 |
| 11484498 | October 6, 2037 | Drug product | None | 211340 |
| 12721843 | October 6, 2037 | Drug product | None | 211340 |
| 10952998 | October 6, 2037 | Drug product | None | 211340 |
| 12383498 | October 6, 2037 | Drug product | None | 211340 |
| 11364230 | October 6, 2037 | Drug product | None | 211340 |
| 12053461 | October 6, 2037 | Drug product | None | 211340 |
| 10695329 | October 16, 2037 | Drug product | None | 211340 |
| 10799453 | April 11, 2039 | Drug product | None | 211340 |
Katerzia NDC codes
Questions
Is there a generic for Katerzia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Katerzia (amlodipine benzoate). The Orange Book shows its last listed patent expires April 11, 2039.
What is the generic name for Katerzia?
The active ingredient in Katerzia is amlodipine benzoate, per the FDA Orange Book.
When does the Katerzia patent expire?
The last patent listed for Katerzia in the Orange Book expires April 11, 2039. 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.