FDA Orange Book
Is there a generic for Baxdela?
Baxdela contains delafloxacin. 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 Baxdela (delafloxacin). The Orange Book shows its last listed patent expires June 2, 2034 and its last listed exclusivity ends June 19, 2027.
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Baxdela products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 300MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 450MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208611, 208610, held by MELINTA SUBSIDIARY CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Baxdela patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8273892 | August 6, 2026 | Drug substance | None | 208611 |
| 8252813 | October 2, 2026 | Drug product | U-2028 | 208611 |
| 9200088 | March 13, 2029 | Drug product | None | 208611 |
| 9750822 | March 13, 2029 | Drug product | None | 208611 |
| 7635773 | March 13, 2029 | Drug product | None | 208611 |
| 8410077 | March 13, 2029 | Drug product | None | 208611 |
| 8871938 | September 23, 2029 | Drug substance | None | 208611 |
| RE46617 | December 28, 2029 | Drug substance | None | 208611 |
| 7728143 | June 19, 2031 | Drug substance | None | 208611 |
| 12138257 | May 1, 2032 | Drug product | None | 208611 |
| 9493582 | February 27, 2033 | Drug product | None | 208611 |
| 12558349 | March 14, 2034 | Method of use | U-3967 | 208611 |
| 12036219 | June 2, 2034 | Method of use | U-3967 | 208611 |
Baxdela exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 19, 2022 | 208611 |
| GAIN | Generating Antibiotic Incentives Now | June 19, 2027 | 208611 |
Baxdela NDC codes
Questions
Is there a generic for Baxdela?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Baxdela (delafloxacin). The Orange Book shows its last listed patent expires June 2, 2034 and its last listed exclusivity ends June 19, 2027.
What is the generic name for Baxdela?
The active ingredient in Baxdela is delafloxacin, per the FDA Orange Book.
When does the Baxdela patent expire?
The last patent listed for Baxdela in the Orange Book expires June 2, 2034. 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.