FDA Orange Book
Generic for Sanctura
Sanctura 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 is trospium chloride. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Sanctura and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Sanctura products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 20MG | Discontinued | None | 7 | AB |
NDA 021595, 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 |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 091575 | AB (A-rated, therapeutically equivalent) | August 13, 2010 | 20MG |
| PADAGIS US LLC | 091573 | AB (A-rated, therapeutically equivalent) | November 17, 2010 | 20MG |
| APOTEX INC | 091513 | AB (A-rated, therapeutically equivalent) | December 6, 2011 | 20MG |
| INVAGEN PHARMACEUTICALS INC | 091688 | AB (A-rated, therapeutically equivalent) | August 23, 2016 | 20MG |
| HERITAGE PHARMACEUTICALS INC | 204945 | AB (A-rated, therapeutically equivalent) | August 30, 2016 | 20MG |
| CHARTWELL RX SCIENCES LLC | 215781 | AB (A-rated, therapeutically equivalent) | February 16, 2022 | 20MG |
| MACLEODS PHARMACEUTICALS LTD | 206472 | AB (A-rated, therapeutically equivalent) | June 18, 2024 | 20MG |
Questions
Is there a generic for Sanctura?
Yes. The generic name for Sanctura is trospium chloride. 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 Sanctura?
The active ingredient in Sanctura 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.