FDA Orange Book
Is there a generic for Nuvessa?
Nuvessa contains metronidazole. 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 Nuvessa (metronidazole). The Orange Book shows its last listed patent expires June 28, 2032.
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Nuvessa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, vaginal | 1.3% | Marketed (Rx) | None | 0 | None |
NDA 205223, held by ALEMBIC THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nuvessa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8877792 | February 2, 2028 | Drug product | None | 205223 |
| 7893097 | February 19, 2028 | Drug product | None | 205223 |
| 8658678 | June 27, 2028 | Method of use | U-1682 | 205223 |
| 9198858 | June 28, 2032 | Method of use | U-1664 | 205223 |
| 8946276 | June 28, 2032 | Method of use | U-1664 | 205223 |
| 10238634 | June 28, 2032 | Drug product | None | 205223 |
| 10596155 | June 28, 2032 | Drug product | None | 205223 |
Nuvessa NDC codes
Questions
Is there a generic for Nuvessa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nuvessa (metronidazole). The Orange Book shows its last listed patent expires June 28, 2032.
What is the generic name for Nuvessa?
The active ingredient in Nuvessa is metronidazole, per the FDA Orange Book.
When does the Nuvessa patent expire?
The last patent listed for Nuvessa in the Orange Book expires June 28, 2032. 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.
More on Nuvessa and Metronidazole
- What is Metronidazole used for?FDA label uses
- Is Metronidazole a controlled substance?Federal schedule
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- Generic for MetrocreamFDA Orange Book
- Generic for NoritateFDA Orange Book
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- Generic for Metro I.v.FDA Orange Book
- Generic for MetrolotionFDA Orange Book
- Generic for LikmezFDA Orange Book
- Generic for ProtostatFDA Orange Book
- Nitroimidazole Antimicrobials listFDA drug class
- NDC 0642-7466Nuvessa NDC record