Orange Book product · Brand (NDA)
PROTONIX
PANTOPRAZOLE SODIUM
At a glance
Nov 14, 2007
Approved
Brand (NDA)
Application
AB
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2007
18 yr 10 mo ago
Patent 7544370 expires
Listed drug product patent expiration.
Jun 07, 2026
12 d ago
Today
Patent 7544370*PED expires
Listed listed patent expiration.
Dec 07, 2026
in 6 mo
Pharmaceutical detail
Active ingredient
PANTOPRAZOLE SODIUM
Strength
EQ 40MG BASE
Dosage form
FOR SUSPENSION, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 022020
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 217512 · BAXTER HLTHCARE CORP
- 2017PANTOPRAZOLE SODIUMBrand (NDA)
NDA 209463 · HIKMA
- 2001PROTONIXBrand (NDA)
NDA 020987 · WYETH PHARMS
- 2001PROTONIX IVBrand (NDA)
NDA 020988 · WYETH PHARMS
- 2026PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 219973 · SHUANGCHENG
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 215074 · DEVA HOLDING AS
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 217923 · AUROBINDO PHARMA LTD
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 217458 · CIPLA
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 219230 · ALEMBIC
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 219087 · GRAVITI PHARMS
- 2024PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 216021 · FRESENIUS KABI USA
- 2024PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 215880 · MANKIND PHARMA
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7544370 | Jun 07, 2026 | 12 d ago | Product |
| 7544370*PED | Dec 07, 2026 | in 6 mo |

