FDA Orange Book
Generic for Protonix IV
Protonix IV contains pantoprazole. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Protonix IV is pantoprazole. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Protonix IV products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 40MG BASE/VIAL | Marketed (Rx) | AP | 11 | AP |
NDA 020988, held by WYETH PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pantoprazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 079197 | AP (A-rated, therapeutically equivalent) | November 8, 2012 | EQ 40MG BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 205675 | AP (A-rated, therapeutically equivalent) | March 30, 2016 | EQ 40MG BASE/VIAL |
| HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | 209524 | AP (A-rated, therapeutically equivalent) | August 30, 2021 | EQ 40MG BASE/VIAL |
| ASPIRO PHARMA LTD | 213778 | AP (A-rated, therapeutically equivalent) | May 18, 2022 | EQ 40MG BASE/VIAL |
| BE PHARMACEUTICALS AG | 216171 | AP (A-rated, therapeutically equivalent) | May 18, 2022 | EQ 40MG BASE/VIAL |
| GLAND PHARMA LTD | 204400 | AP (A-rated, therapeutically equivalent) | May 18, 2022 | EQ 40MG BASE/VIAL |
| KNACK PHARMACEUTICALS INC | 214680 | AP (A-rated, therapeutically equivalent) | May 19, 2022 | EQ 40MG BASE/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 215860 | AP (A-rated, therapeutically equivalent) | August 29, 2022 | EQ 40MG BASE/VIAL |
| ALEMBIC PHARMACEUTICALS LTD | 219230 | AP (A-rated, therapeutically equivalent) | March 31, 2025 | EQ 40MG BASE/VIAL |
| DEVA HOLDING AS | 215074 | AP (A-rated, therapeutically equivalent) | May 16, 2025 | EQ 40MG BASE/VIAL |
| HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD | 219973 | AP (A-rated, therapeutically equivalent) | April 22, 2026 | EQ 40MG BASE/VIAL |
Protonix IV exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | August 12, 2027 | 020988 |
Protonix IV NDC codes
Questions
Is there a generic for Protonix IV?
Yes. The generic name for Protonix IV is pantoprazole. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Protonix IV?
The active ingredient in Protonix IV is pantoprazole, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.