FDA Orange Book · active-ingredient family
Trospium chloride
Trospium chloride is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SANCTURA XR · NDA 022103
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SANCTURA XRRLD | ALLERGAN | NDA 022103 | — | Aug 03, 2007 | |
| SANCTURARLD | ALLERGAN | NDA 021595 | — | May 28, 2004 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TROSPIUM CHLORIDE | MACLEODS PHARMS LTD | ANDA 206472 | AB | Jun 18, 2024 | |
| TROSPIUM CHLORIDE | ZAMEER PHARMS | ANDA 215781 | AB | Feb 16, 2022 | |
| TROSPIUM CHLORIDE | UTOPIC PHARMS | ANDA 214760 | AB | Apr 30, 2021 | |
| TROSPIUM CHLORIDE | GRANULES | ANDA 213185 | AB | Apr 23, 2020 | |
| TROSPIUM CHLORIDE | HERITAGE PHARMS INC | ANDA 204945 | AB | Aug 30, 2016 | |
| TROSPIUM CHLORIDE | INVAGEN PHARMS | ANDA 091688 | AB | Aug 23, 2016 | |
| TROSPIUM CHLORIDE | UPSHER SMITH LABS | ANDA 091635 | — | Apr 29, 2015 | |
| TROSPIUM CHLORIDE | PADAGIS US | ANDA 201291 | AB | May 24, 2013 | |
| TROSPIUM CHLORIDE | ACTAVIS LABS FL INC | ANDA 091289 | AB | Oct 12, 2012 | |
| TROSPIUM CHLORIDE | APOTEX | ANDA 091513 | AB | Dec 06, 2011 | |
| TROSPIUM CHLORIDE | PADAGIS US | ANDA 091573 | AB | Nov 17, 2010 | |
| TROSPIUM CHLORIDE | GLENMARK PHARMS LTD | ANDA 091575 | AB | Aug 13, 2010 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Trospium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
