FDA Orange Book
Generic for Byvalson
Byvalson contains nebivolol and valsartan. 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 Byvalson is nebivolol and valsartan. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Byvalson products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 5MG BASE;80MG | Discontinued | None | 1 | None |
NDA 206302, 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 nebivolol and valsartan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PRINSTON PHARMACEUTICAL INC | 210596 | None (No TE code listed) | September 19, 2022 | EQ 5MG BASE;80MG |
Byvalson patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7803838 | August 29, 2026 | Drug product | None | 206302 |
| 7838552 | October 4, 2027 | Method of use | U-185 | 206302 |
Questions
Is there a generic for Byvalson?
Yes. The generic name for Byvalson is nebivolol and valsartan. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Byvalson?
The active ingredient in Byvalson is nebivolol and valsartan, per the FDA Orange Book.
When does the Byvalson patent expire?
The last patent listed for Byvalson in the Orange Book expires October 4, 2027. 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.