FDA Orange Book
Is there a generic for Nuzyra?
Nuzyra contains omadacycline. 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 Nuzyra (omadacycline). The Orange Book shows its last listed patent expires October 31, 2037 and its last listed exclusivity ends May 13, 2029.
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Nuzyra 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 |
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209817, 209816, held by PARATEK PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nuzyra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10124014 | March 5, 2029 | Method of use | U-2449 | 209817 |
| 9724358 | March 5, 2029 | Method of use | U-1569 | 209817 |
| 9265740 | March 5, 2029 | Drug product | None | 209817 |
| 8383610 | September 23, 2030 | Drug substance | None | 209816 |
| 9265740 | October 24, 2030 | Drug product | U-1569 | 209816 |
| 9314475 | March 18, 2031 | Drug product | None | 209816 |
| 10111890 | August 3, 2037 | Method of use | U-2444 | 209816 |
| 10383884 | October 31, 2037 | Method of use | U-2576 | 209817 |
| 10835542 | October 31, 2037 | Method of use | U-2576 | 209817 |
Nuzyra exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 2, 2023 | 209817 |
| GAIN | Generating Antibiotic Incentives Now | October 2, 2028 | 209817 |
| M-320 | Miscellaneous | May 13, 2029 | 209817 |
Nuzyra NDC codes
Questions
Is there a generic for Nuzyra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nuzyra (omadacycline). The Orange Book shows its last listed patent expires October 31, 2037 and its last listed exclusivity ends May 13, 2029.
What is the generic name for Nuzyra?
The active ingredient in Nuzyra is omadacycline, per the FDA Orange Book.
When does the Nuzyra patent expire?
The last patent listed for Nuzyra in the Orange Book expires October 31, 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.