FDA Orange Book
Is there a generic for Etcamah?
Etcamah contains camizestrant. 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 Etcamah (camizestrant). The Orange Book shows its last listed patent expires October 22, 2041 and its last listed exclusivity ends September 4, 2031.
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Etcamah products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 75MG | Marketed (Rx) | None | 0 | None |
NDA 220359, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Etcamah patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12077530 | October 13, 2037 | Method of use | U-4607 | 220359 |
| 10961241 | October 13, 2037 | Method of use | U-4607 | 220359 |
| 10590130 | October 13, 2037 | Drug substance, Drug product | None | 220359 |
| 10131663 | October 13, 2037 | Drug substance, Drug product | None | 220359 |
| 12364689 | September 18, 2041 | Method of use | U-4606 | 220359 |
| 12453729 | October 22, 2041 | Drug product | None | 220359 |
Etcamah exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 4, 2031 | 220359 |
Etcamah NDC codes
Questions
Is there a generic for Etcamah?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Etcamah (camizestrant). The Orange Book shows its last listed patent expires October 22, 2041 and its last listed exclusivity ends September 4, 2031.
What is the generic name for Etcamah?
The active ingredient in Etcamah is camizestrant, per the FDA Orange Book.
When does the Etcamah patent expire?
The last patent listed for Etcamah in the Orange Book expires October 22, 2041. 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.