FDA Orange Book
Is there a generic for Xerava?
Xerava contains eravacycline. 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 Xerava (eravacycline). The Orange Book shows its last listed patent expires October 19, 2037 and its last listed exclusivity ends August 27, 2028.
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Xerava products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 100MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, intravenous | EQ 50MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 211109, held by TETRAPHASE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xerava patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8796245 | August 7, 2029 | Method of use | U-2380 | 211109 |
| 8906887 | August 27, 2032 | Drug product | None | 211109 |
| 11578044 | October 19, 2037 | Drug substance | None | 211109 |
| 10961190 | October 19, 2037 | Drug substance | None | 211109 |
Xerava exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 27, 2023 | 211109 |
| GAIN | Generating Antibiotic Incentives Now | August 27, 2028 | 211109 |
Xerava NDC codes
Questions
Is there a generic for Xerava?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xerava (eravacycline). The Orange Book shows its last listed patent expires October 19, 2037 and its last listed exclusivity ends August 27, 2028.
What is the generic name for Xerava?
The active ingredient in Xerava is eravacycline, per the FDA Orange Book.
When does the Xerava patent expire?
The last patent listed for Xerava in the Orange Book expires October 19, 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.