FDA Orange Book
Is there a generic for Cardamyst?
Cardamyst contains etripamil. 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 Cardamyst (etripamil). The Orange Book shows its last listed patent expires July 15, 2042 and its last listed exclusivity ends December 12, 2030.
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Cardamyst products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | 70MG | Marketed (Rx) | None | 0 | None |
NDA 218571, held by MILESTONE PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cardamyst patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10010522 | June 19, 2028 | Method of use | U-38 | 218571 |
| 9463179 | June 19, 2028 | Method of use | U-4370 | 218571 |
| 10010523 | June 19, 2028 | Drug substance | None | 218571 |
| 9227918 | June 19, 2028 | Drug product | None | 218571 |
| 10117848 | April 13, 2036 | Drug product | U-4370 | 218571 |
| 12257224 | July 15, 2042 | Method of use | U-4370 | 218571 |
Cardamyst exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 12, 2030 | 218571 |
Cardamyst NDC codes
Questions
Is there a generic for Cardamyst?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cardamyst (etripamil). The Orange Book shows its last listed patent expires July 15, 2042 and its last listed exclusivity ends December 12, 2030.
What is the generic name for Cardamyst?
The active ingredient in Cardamyst is etripamil, per the FDA Orange Book.
When does the Cardamyst patent expire?
The last patent listed for Cardamyst in the Orange Book expires July 15, 2042. 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.