FDA Orange Book
Generic for Levitra
Levitra 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 Levitra is vardenafil. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Levitra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 2.5MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 20MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 5 | AB |
NDA 021400, 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 091347 | AB (A-rated, therapeutically equivalent) | May 3, 2012 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| CROSSMEDIKA SA | 209057 | AB (A-rated, therapeutically equivalent) | October 31, 2018 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 208960 | AB (A-rated, therapeutically equivalent) | October 31, 2018 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 204632 | AB (A-rated, therapeutically equivalent) | October 22, 2019 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 214031 | AB (A-rated, therapeutically equivalent) | August 4, 2020 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE |
Levitra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8273876 | July 23, 2027 | Method of use | U-1288 | 021400 |
Questions
Is there a generic for Levitra?
Yes. The generic name for Levitra is vardenafil. 5 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 Levitra?
The active ingredient in Levitra is vardenafil, per the FDA Orange Book.
When does the Levitra patent expire?
The last patent listed for Levitra in the Orange Book expires July 23, 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.