Orange Book product · Brand (NDA)
THIOLA EC
TIOPRONIN
At a glance
Jun 28, 2019
Approved
Brand (NDA)
Application
AB
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 2019
7 yr 1 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
Jun 28, 2026
in 9 d
Patent 11458104 expires
Listed method-of-use patent (U-3441) expiration.
Nov 14, 2038
in 12 yr 7 mo
Pharmaceutical detail
Active ingredient
TIOPRONIN
Strength
100MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 211843
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.
- 1988THIOLABrand (NDA)
NDA 019569 · MISSION PHARMA
- 2025TIOPRONINGeneric (ANDA)
ANDA 216278 · AMNEAL
- 2024TIOPRONINGeneric (ANDA)
ANDA 216456 · TEVA PHARMS INC
- 2024VENXXIVAGeneric (ANDA)
ANDA 216990 · TORRENT
- 2023TIOPRONINGeneric (ANDA)
ANDA 217219 · PH HEALTH
- 2022TIOPRONINGeneric (ANDA)
ANDA 216198 · PH HEALTH
- 2021TIOPRONINGeneric (ANDA)
ANDA 214326 · TEVA PHARMS USA INC
Marketing exclusivity (1)
- ODE*FDA marketing exclusivity
Jun 28, 2026
in 9 d
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11458104 | Nov 14, 2038 | in 12 yr 7 mo | U-3441 |
