FDA Orange Book
Is there a generic for Tyzavan?
Tyzavan contains vancomycin. 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 Tyzavan (vancomycin). The Orange Book shows its last listed patent expires November 6, 2035.
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Tyzavan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 211962, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tyzavan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11517609 | November 6, 2035 | Method of use | U-282 | 211962 |
| 10039804 | November 6, 2035 | Drug product | U-282 | 211962 |
| 10188697 | November 6, 2035 | Drug product | U-282 | 211962 |
| 10849956 | November 6, 2035 | Drug product | None | 211962 |
| 12161690 | November 6, 2035 | Drug product | None | 211962 |
| 11628200 | November 6, 2035 | Drug product | None | 211962 |
Tyzavan NDC codes
Questions
Is there a generic for Tyzavan?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tyzavan (vancomycin). The Orange Book shows its last listed patent expires November 6, 2035.
What is the generic name for Tyzavan?
The active ingredient in Tyzavan is vancomycin, per the FDA Orange Book.
When does the Tyzavan patent expire?
The last patent listed for Tyzavan in the Orange Book expires November 6, 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.
More on Tyzavan and Vancomycin
- What is Vancomycin used for?FDA label uses
- Is Vancomycin a controlled substance?Federal schedule
- Generic for Vancocin HydrochlorideFDA Orange Book
- Generic for Firvanq KitFDA Orange Book
- Glycopeptide Antibacterials listFDA drug class
- NDC 0143-9466Tyzavan NDC record
- NDC 0143-9467Tyzavan NDC record
- NDC 0143-9468Tyzavan NDC record