FDA Orange Book
Is there a generic for Byfavo?
Byfavo contains remimazolam. 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 Byfavo (remimazolam). The Orange Book shows its last listed patent expires January 13, 2034.
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Byfavo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 20MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 212295, held by ACACIA PHARMA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Byfavo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10961250 | July 10, 2027 | Drug product | U-2968 | 212295 |
| 10472365 | July 10, 2027 | Method of use | U-2968 | 212295 |
| 9777007 | July 10, 2027 | Drug product | None | 212295 |
| 9914738 | July 10, 2027 | Drug product | None | 212295 |
| 9737547 | November 7, 2031 | Method of use | U-2968 | 212295 |
| 10052334 | November 7, 2031 | Method of use | U-2968 | 212295 |
| 10195210 | November 7, 2031 | Method of use | U-2968 | 212295 |
| 10342800 | November 7, 2031 | Method of use | U-2968 | 212295 |
| 10722522 | November 7, 2031 | Method of use | U-2968 | 212295 |
| 9561236 | April 30, 2033 | Method of use | U-2968 | 212295 |
| 9827251 | January 13, 2034 | Method of use | U-2968 | 212295 |
Byfavo NDC codes
Questions
Is there a generic for Byfavo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Byfavo (remimazolam). The Orange Book shows its last listed patent expires January 13, 2034.
What is the generic name for Byfavo?
The active ingredient in Byfavo is remimazolam, per the FDA Orange Book.
When does the Byfavo patent expire?
The last patent listed for Byfavo in the Orange Book expires January 13, 2034. 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.