Orange Book product · Brand (NDA)
TOVIAZ
FESOTERODINE FUMARATE
At a glance
Oct 31, 2008
Approved
Brand (NDA)
Application
AB
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2008
17 yr 11 mo ago
Today
Patent 7807715 expires
Listed drug product patent expiration.
Jun 07, 2027
in 1 yr
Patent 8088398 expires
Listed drug product patent expiration.
Jun 07, 2027
in 1 yr
Patent 8501723 expires
Listed drug product patent expiration.
Jun 07, 2027
in 1 yr
Patent 7807715*PED expires
Listed listed patent expiration.
Dec 07, 2027
in 1 yr 6 mo
Patent 8088398*PED expires
Listed listed patent expiration.
Dec 07, 2027
in 1 yr 6 mo
Patent 8501723*PED expires
Listed listed patent expiration.
Dec 07, 2027
in 1 yr 6 mo
Pharmaceutical detail
Active ingredient
FESOTERODINE FUMARATE
Strength
4MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 022030
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204792 · HETERO LABS LTD V
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204983 · CHARTWELL RX
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 205012 · ACCORD HLTHCARE
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204868 · ACTAVIS LABS FL INC
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204973 · ALEMBIC
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 205002 · AMNEAL PHARMS NY
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204504 · ANI PHARMS
- 2019FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204975 · DR REDDYS
- 2017FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204946 · ZYDUS PHARMS
- 2017FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 205007 · AUROBINDO PHARMA
- 2015FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204827 · ALKEM LABS LTD
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7807715 | Jun 07, 2027 | in 1 yr | ProductU-913 |
| 8088398 | Jun 07, 2027 | in 1 yr | ProductU-913 |
| 8501723 | Jun 07, 2027 | in 1 yr | Product |
| 7807715*PED | Dec 07, 2027 | in 1 yr 6 mo | |
| 8088398*PED | Dec 07, 2027 | in 1 yr 6 mo | |
| 8501723*PED | Dec 07, 2027 | in 1 yr 6 mo |

