FDA Orange Book
Is there a generic for Kimyrsa?
Kimyrsa contains oritavancin. 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 Kimyrsa (oritavancin). The Orange Book shows its last listed patent expires July 16, 2035.
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Kimyrsa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 1.2GM BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 214155, held by MELINTA THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kimyrsa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12514899 | August 29, 2029 | Method of use | U-4398 | 214155 |
| 8420592 | August 29, 2029 | Method of use | U-3101 | 214155 |
| 9682061 | April 26, 2030 | Method of use | U-3101 | 214155 |
| 9649352 | July 16, 2035 | Drug substance, Drug product | None | 214155 |
Kimyrsa NDC codes
Questions
Is there a generic for Kimyrsa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kimyrsa (oritavancin). The Orange Book shows its last listed patent expires July 16, 2035.
What is the generic name for Kimyrsa?
The active ingredient in Kimyrsa is oritavancin, per the FDA Orange Book.
When does the Kimyrsa patent expire?
The last patent listed for Kimyrsa in the Orange Book expires July 16, 2035. 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.