FDA Orange Book · active-ingredient family
Tolterodine tartrate
Tolterodine tartrate is approved as 2 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DETROL LA · NDA 021228
2
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DETROL LARLD×2 | UPJOHN | NDA 021228 | AB | Dec 22, 2000 | |
| DETROLRLD×2 | UPJOHN | NDA 020771 | AB | Mar 25, 1998 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOLTERODINE TARTRATE×2 | UNICHEM | ANDA 216917 | AB | Aug 27, 2024 | |
| TOLTERODINE TARTRATE×2 | HETERO LABS LTD V | ANDA 204397 | AB | Aug 02, 2021 | |
| TOLTERODINE TARTRATE×2 | UTOPIC PHARMS | ANDA 213858 | AB | Feb 02, 2021 | |
| TOLTERODINE TARTRATE×2 | UNICHEM | ANDA 205399 | AB | Aug 05, 2020 | |
| TOLTERODINE TARTRATE×2 | AJANTA PHARMA LTD | ANDA 213397 | AB | May 19, 2020 | |
| TOLTERODINE TARTRATE×2 | UNIQUE | ANDA 204721 | AB | Jan 24, 2020 | |
| TOLTERODINE TARTRATE×2 | RISING | ANDA 210775 | AB | Dec 30, 2019 | |
| TOLTERODINE TARTRATE×2 | INVENTIA HLTHCARE | ANDA 204562 | AB | Aug 19, 2019 | |
| TOLTERODINE TARTRATE×2 | HETERO LABS LTD III | ANDA 206419 | AB | Dec 12, 2017 | |
| TOLTERODINE TARTRATE×2 | TEVA PHARMS USA | ANDA 079141 | AB | Nov 22, 2016 | |
| TOLTERODINE TARTRATE×2 | MACLEODS PHARMS LTD | ANDA 203409 | AB | Aug 31, 2015 | |
| TOLTERODINE TARTRATE×2 | TORRENT | ANDA 203016 | AB | Aug 11, 2015 | |
| TOLTERODINE TARTRATE×2 | IVAX SUB TEVA PHARMS | ANDA 077006 | AB | Feb 23, 2015 | |
| TOLTERODINE TARTRATE×2 | AUROBINDO PHARMA USA | ANDA 201486 | — | Oct 31, 2013 | |
| TOLTERODINE TARTRATE×2 | PHARMOBEDIENT | ANDA 202641 | — | Nov 27, 2012 | |
| TOLTERODINE TARTRATE×2 | APOTEX CORP | ANDA 200164 | — | Sep 25, 2012 |
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.
Tolterodine tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
