FDA Orange Book
Generic for Staxyn
Staxyn contains vardenafil. 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 Staxyn is vardenafil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Staxyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 10MG | Discontinued | None | 2 | AB |
NDA 200179, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic vardenafil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 208324 | AB (A-rated, therapeutically equivalent) | November 16, 2018 | 10MG |
| MACLEODS PHARMACEUTICALS LTD | 205988 | AB (A-rated, therapeutically equivalent) | March 10, 2020 | 10MG |
Staxyn patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8613950 | December 23, 2028 | Drug product | None | 200179 |
Questions
Is there a generic for Staxyn?
Yes. The generic name for Staxyn is vardenafil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Staxyn?
The active ingredient in Staxyn is vardenafil, per the FDA Orange Book.
When does the Staxyn patent expire?
The last patent listed for Staxyn in the Orange Book expires December 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.