FDA Orange Book
Is there a generic for Camcevi Etm?
Camcevi Etm contains leuprolide. 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 Camcevi Etm (leuprolide). The Orange Book shows its last listed patent expires January 1, 2039 and its last listed exclusivity ends August 25, 2028.
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Camcevi Etm products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, subcutaneous | EQ 21MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219745, held by ACCORD BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Camcevi Etm patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9744207 | January 16, 2027 | Drug product | None | 219745 |
| 10646572 | January 16, 2027 | Drug product | None | 219745 |
| 9572857 | August 2, 2029 | Drug product | None | 219745 |
| 12133878 | December 18, 2037 | Drug product | None | 219745 |
| 11717555 | January 1, 2039 | Drug product | None | 219745 |
Camcevi Etm exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | August 25, 2028 | 219745 |
Questions
Is there a generic for Camcevi Etm?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Camcevi Etm (leuprolide). The Orange Book shows its last listed patent expires January 1, 2039 and its last listed exclusivity ends August 25, 2028.
What is the generic name for Camcevi Etm?
The active ingredient in Camcevi Etm is leuprolide, per the FDA Orange Book.
When does the Camcevi Etm patent expire?
The last patent listed for Camcevi Etm in the Orange Book expires January 1, 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.