FDA Orange Book
Generic for Dalvance
Dalvance contains dalbavancin. 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
Yes. The generic name for Dalvance is dalbavancin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Dalvance products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 500MG BASE/VIAL | Marketed (Rx) | AP | 5 | AP |
NDA 021883, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dalbavancin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS INC | 219465 | AP (A-rated, therapeutically equivalent) | October 23, 2025 | EQ 500MG BASE/VIAL |
| FRESENIUS KABI USA LLC | 217591 | AP (A-rated, therapeutically equivalent) | November 10, 2025 | EQ 500MG BASE/VIAL |
| KINDOS PHARMACEUTICALS CO LTD | 218929 | AP (A-rated, therapeutically equivalent) | November 26, 2025 | EQ 500MG BASE/VIAL |
| LONG GROVE PHARMACEUTICALS LLC | 218602 | AP (A-rated, therapeutically equivalent) | February 26, 2026 | EQ 500MG BASE/VIAL |
| BE PHARMACEUTICALS AG | 219604 | AP (A-rated, therapeutically equivalent) | June 4, 2026 | EQ 500MG BASE/VIAL |
Dalvance patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6900175 | May 23, 2028 | Method of use | U-3499 | 021883 |
Dalvance NDC codes
Questions
Is there a generic for Dalvance?
Yes. The generic name for Dalvance is dalbavancin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Dalvance?
The active ingredient in Dalvance is dalbavancin, per the FDA Orange Book.
When does the Dalvance patent expire?
The last patent listed for Dalvance in the Orange Book expires May 23, 2028. 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.