FDA Orange Book
Generic for Toviaz
Toviaz contains fesoterodine. 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 Toviaz is fesoterodine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Toviaz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 4MG | Marketed (Rx) | AB | 7 | AB |
| tablet, extended release, oral | 8MG | Marketed (Rx) | AB | 7 | AB |
NDA 022030, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fesoterodine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 204827 | AB (A-rated, therapeutically equivalent) | December 10, 2015 | 4MG, 8MG |
| AUROBINDO PHARMA LTD | 205007 | AB (A-rated, therapeutically equivalent) | February 17, 2017 | 4MG, 8MG |
| ZYDUS PHARMACEUTICALS USA INC | 204946 | AB (A-rated, therapeutically equivalent) | October 3, 2017 | 4MG, 8MG |
| DR REDDYS LABORATORIES LTD | 204975 | AB (A-rated, therapeutically equivalent) | August 13, 2019 | 4MG, 8MG |
| ALEMBIC PHARMACEUTICALS LTD | 204973 | AB (A-rated, therapeutically equivalent) | January 4, 2023 | 4MG, 8MG |
| AMNEAL PHARMACEUTICALS OF NY LLC | 205002 | AB (A-rated, therapeutically equivalent) | January 4, 2023 | 4MG, 8MG |
| HETERO LABS LTD UNIT V | 204792 | AB (A-rated, therapeutically equivalent) | January 9, 2024 | 4MG, 8MG |
Toviaz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8088398 | June 7, 2027 | Drug product | U-913 | 022030 |
| 7807715 | June 7, 2027 | Drug product | U-913 | 022030 |
| 8501723 | June 7, 2027 | Drug product | None | 022030 |
| 7807715*PED | December 7, 2027 | Method of use | None | 022030 |
| 8088398*PED | December 7, 2027 | Method of use | None | 022030 |
| 8501723*PED | December 7, 2027 | Method of use | None | 022030 |
Toviaz NDC codes
Questions
Is there a generic for Toviaz?
Yes. The generic name for Toviaz is fesoterodine. 7 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 Toviaz?
The active ingredient in Toviaz is fesoterodine, per the FDA Orange Book.
When does the Toviaz patent expire?
The last patent listed for Toviaz in the Orange Book expires December 7, 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.