FDA Orange Book

Generic for Protonix

Protonix 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 is pantoprazole. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Protonix products in the Orange Book

Protonix products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
for suspension, delayed release, oral	EQ 40MG BASE	Marketed (Rx)	AB	6	AB
tablet, delayed release, oral	EQ 20MG BASE	Marketed (Rx)	AB	12	AB
tablet, delayed release, oral	EQ 40MG BASE	Marketed (Rx)	AB	13	AB

NDA 022020, 020987, 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

Approved generic versions of Protonix
Company	ANDA	TE code	Approved	Strengths
APOTEX INC	091231	AB (A-rated, therapeutically equivalent)	January 19, 2011	EQ 20MG BASE, EQ 40MG BASE
DR REDDYS LABORATORIES LTD	077619	AB (A-rated, therapeutically equivalent)	January 19, 2011	EQ 20MG BASE, EQ 40MG BASE
MYLAN PHARMACEUTICALS INC	090970	AB (A-rated, therapeutically equivalent)	January 19, 2011	EQ 20MG BASE, EQ 40MG BASE
TORRENT PHARMACEUTICALS LTD	090074	AB (A-rated, therapeutically equivalent)	January 19, 2011	EQ 20MG BASE, EQ 40MG BASE
LANNETT CO INC	078281	AB (A-rated, therapeutically equivalent)	January 20, 2011	EQ 20MG BASE, EQ 40MG BASE
RUBICON RESEARCH LTD	090807	AB (A-rated, therapeutically equivalent)	May 2, 2012	EQ 20MG BASE, EQ 40MG BASE
AUROBINDO PHARMA LTD	202038	AB (A-rated, therapeutically equivalent)	September 28, 2012	EQ 20MG BASE, EQ 40MG BASE
HETERO LABS LTD UNIT V	202882	AB (A-rated, therapeutically equivalent)	September 10, 2014	EQ 20MG BASE, EQ 40MG BASE
ORBION PHARMACEUTICALS PRIVATE LTD	202052	AB (A-rated, therapeutically equivalent)	December 2, 2014	EQ 20MG BASE, EQ 40MG BASE
AMNEAL PHARMACEUTICALS	205119	AB (A-rated, therapeutically equivalent)	January 26, 2016	EQ 20MG BASE, EQ 40MG BASE
SUN PHARMACEUTICAL INDUSTRIES LTD	213725	AB (A-rated, therapeutically equivalent)	June 30, 2020	EQ 40MG BASE
MANKIND PHARMA LTD	215880	AB (A-rated, therapeutically equivalent)	July 26, 2022	EQ 40MG BASE
AJANTA PHARMA LTD	217416	AB (A-rated, therapeutically equivalent)	February 9, 2023	EQ 40MG BASE
DEXCEL PHARMA TECHNOLOGIES LTD	216247	AB (A-rated, therapeutically equivalent)	June 16, 2023	EQ 40MG BASE
ANNORA PHARMA PRIVATE LTD	216139	AB (A-rated, therapeutically equivalent)	October 27, 2023	EQ 40MG BASE
GRANULES INDIA LTD	217282	AB (A-rated, therapeutically equivalent)	December 11, 2023	EQ 20MG BASE, EQ 40MG BASE
GRAVITI PHARMACEUTICALS PRIVATE LTD	219087	AB (A-rated, therapeutically equivalent)	January 16, 2025	EQ 20MG BASE, EQ 40MG BASE
AUROBINDO PHARMA LTD	217923	AB (A-rated, therapeutically equivalent)	March 31, 2025	EQ 40MG BASE
CIPLA LTD	217458	AB (A-rated, therapeutically equivalent)	March 31, 2025	EQ 40MG BASE

Protonix patents

Patents listed for Protonix
Patent	Expires	Covers	Use code	NDA
7544370	June 7, 2026	Drug product	None	022020
7544370*PED	December 7, 2026	Method of use	None	022020

Protonix NDC codes

Questions

Is there a generic for Protonix?

Yes. The generic name for Protonix is pantoprazole. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Protonix?

The active ingredient in Protonix is pantoprazole, per the FDA Orange Book.

When does the Protonix patent expire?

The last patent listed for Protonix in the Orange Book expires December 7, 2026. A listed patent expiry date is not a generic launch date.

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.