FDA Orange Book
Is there a generic for Orlynvah?
Orlynvah contains sulopenem etzadroxil and probenecid. 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 Orlynvah (sulopenem etzadroxil and probenecid). The Orange Book shows its last listed patent expires December 23, 2039 and its last listed exclusivity ends October 25, 2034.
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Orlynvah products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 500MG;500MG | Marketed (Rx) | None | 0 | None |
NDA 213972, held by ITERUM THERAPEUTICS US LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Orlynvah patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7795243 | June 3, 2029 | Drug substance, Drug product | U-4026 | 213972 |
| 12109197 | April 1, 2039 | Method of use | U-4026 | 213972 |
| 11554112 | April 1, 2039 | Method of use | U-4026 | 213972 |
| 12544337 | December 23, 2039 | Drug product | U-4026 | 213972 |
| 11478428 | December 23, 2039 | Drug product | U-4026 | 213972 |
Orlynvah exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 25, 2029 | 213972 |
| GAIN | Generating Antibiotic Incentives Now | October 25, 2034 | 213972 |
Orlynvah NDC codes
Questions
Is there a generic for Orlynvah?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orlynvah (sulopenem etzadroxil and probenecid). The Orange Book shows its last listed patent expires December 23, 2039 and its last listed exclusivity ends October 25, 2034.
What is the generic name for Orlynvah?
The active ingredient in Orlynvah is sulopenem etzadroxil and probenecid, per the FDA Orange Book.
When does the Orlynvah patent expire?
The last patent listed for Orlynvah in the Orange Book expires December 23, 2039. 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.