FDA Orange Book
Is there a generic for Ensacove?
Ensacove contains ensartinib. 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 Ensacove (ensartinib). The Orange Book shows its last listed patent expires June 1, 2037 and its last listed exclusivity ends December 18, 2029.
Run it in Rivvi
Map Ensacove and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Ensacove products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
NDA 218171, held by XCOVERY HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ensacove patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8551995 | February 9, 2029 | Drug substance | None | 218171 |
| 9296724 | June 18, 2029 | Drug substance | U-4099 | 218171 |
| 9126947 | November 29, 2031 | Drug substance | None | 218171 |
| 10899744 | June 1, 2037 | Drug substance | U-4099 | 218171 |
Ensacove exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 18, 2029 | 218171 |
Ensacove NDC codes
Questions
Is there a generic for Ensacove?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ensacove (ensartinib). The Orange Book shows its last listed patent expires June 1, 2037 and its last listed exclusivity ends December 18, 2029.
What is the generic name for Ensacove?
The active ingredient in Ensacove is ensartinib, per the FDA Orange Book.
When does the Ensacove patent expire?
The last patent listed for Ensacove in the Orange Book expires June 1, 2037. 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.