FDA Orange Book
Is there a generic for Envarsus XR?
Envarsus XR contains tacrolimus. 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 Envarsus XR (tacrolimus). The Orange Book shows its last listed patent expires August 30, 2028.
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Envarsus XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 0.75MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 4MG BASE | Marketed (Rx) | None | 0 | None |
NDA 206406, held by VELOXIS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Envarsus XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11123331 | May 30, 2028 | Method of use | U-2677 | 206406 |
| 11110081 | May 30, 2028 | Method of use | U-2678 | 206406 |
| 12083103 | May 30, 2028 | Method of use | U-2678 | 206406 |
| 10864199 | May 30, 2028 | Method of use | U-2678 | 206406 |
| 10864199 | May 30, 2028 | Method of use | U-2677 | 206406 |
| 10166190 | May 30, 2028 | Drug product | None | 206406 |
| 9549918 | May 30, 2028 | Drug product | None | 206406 |
| 11419823 | May 30, 2028 | Drug product | None | 206406 |
| 12403095 | May 30, 2028 | Drug product | None | 206406 |
| 8664239 | August 30, 2028 | Method of use | U-1752 | 206406 |
| 8685998 | August 30, 2028 | Drug product | U-1752 | 206406 |
| 8685998 | August 30, 2028 | Drug product | U-2678 | 206406 |
| 8685998 | August 30, 2028 | Drug product | U-2677 | 206406 |
| 8664239 | August 30, 2028 | Method of use | U-2677 | 206406 |
| 8664239 | August 30, 2028 | Method of use | U-2678 | 206406 |
Envarsus XR NDC codes
Questions
Is there a generic for Envarsus XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Envarsus XR (tacrolimus). The Orange Book shows its last listed patent expires August 30, 2028.
What is the generic name for Envarsus XR?
The active ingredient in Envarsus XR is tacrolimus, per the FDA Orange Book.
When does the Envarsus XR patent expire?
The last patent listed for Envarsus XR in the Orange Book expires August 30, 2028. 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.