FDA Orange Book
Generic for Sanctura XR
Sanctura XR contains trospium chloride. 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 Sanctura XR is trospium chloride. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sanctura XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 60MG | Discontinued | None | 4 | AB |
NDA 022103, held by ALLERGAN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic trospium chloride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 091289 | AB (A-rated, therapeutically equivalent) | October 12, 2012 | 60MG |
| PADAGIS US LLC | 201291 | AB (A-rated, therapeutically equivalent) | May 24, 2013 | 60MG |
| GRANULES PHARMACEUTICALS INC | 213185 | AB (A-rated, therapeutically equivalent) | April 23, 2020 | 60MG |
| UTOPIC PHARMACEUTICALS INC | 214760 | AB (A-rated, therapeutically equivalent) | April 30, 2021 | 60MG |
Questions
Is there a generic for Sanctura XR?
Yes. The generic name for Sanctura XR is trospium chloride. 4 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 Sanctura XR?
The active ingredient in Sanctura XR is trospium chloride, 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.