FDA Orange Book
Generic for Vesicare
Vesicare contains solifenacin. 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 Vesicare is solifenacin. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Vesicare products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 18 | AB |
| tablet, oral | 5MG | Discontinued | None | 18 | AB |
NDA 021518, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic solifenacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 091464 | AB (A-rated, therapeutically equivalent) | April 2, 2014 | 10MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 205575 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| ALKEM LABORATORIES LTD | 210224 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| BOSTAL LLC | 210281 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 210582 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| GLENMARK SPECIALTY SA | 209239 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| MSN LABORATORIES PRIVATE LTD | 210688 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| QILU PHARMACEUTICAL CO LTD | 209333 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| SCIEGEN PHARMACEUTICALS INC | 211657 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| WATSON LABORATORIES INC | 202551 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 10MG, 5MG |
| UNICHEM LABORATORIES LTD | 211701 | AB (A-rated, therapeutically equivalent) | August 27, 2019 | 10MG, 5MG |
| NOVITIUM PHARMA LLC | 212214 | AB (A-rated, therapeutically equivalent) | September 26, 2019 | 10MG, 5MG |
| RISING PHARMA HOLDINGS INC | 211423 | AB (A-rated, therapeutically equivalent) | December 11, 2019 | 10MG, 5MG |
| SUNSHINE LAKE PHARMA CO LTD | 213346 | AB (A-rated, therapeutically equivalent) | April 13, 2020 | 10MG, 5MG |
| ANNORA PHARMA PRIVATE LTD | 215761 | AB (A-rated, therapeutically equivalent) | June 15, 2022 | 10MG, 5MG |
| AUROBINDO PHARMA LTD | 206817 | AB (A-rated, therapeutically equivalent) | December 27, 2022 | 10MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 204374 | AB (A-rated, therapeutically equivalent) | February 20, 2024 | 10MG, 5MG |
| JUBILANT GENERICS LTD | 205484 | AB (A-rated, therapeutically equivalent) | October 2, 2024 | 10MG, 5MG |
Questions
Is there a generic for Vesicare?
Yes. The generic name for Vesicare is solifenacin. 18 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 Vesicare?
The active ingredient in Vesicare is solifenacin, per the FDA Orange Book.
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.