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OmniRx › Tools › Generic competition check › Pantoprazole Sodium

Generic competition · all medicines · read 12 November 2026

Is there a generic of Pantoprazole Sodium, and who makes it?

Pantoprazole Sodium appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 30 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 7.1 and 12.6 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Pantoprazole Sodium5 dosage-form groups in the Orange Book
30generic makers listed
  1. Pantoprazole Sodium appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 30 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came between 7.1 and 12.6 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Delayed Release, Oral

Four or more generic makers listed

Brand listed as marketed: Protonix. 13 generic makers with 25 generic products listed as marketed; the first generic approval is dated 2 August 2007.

2000200520102015202020252030013brand 2000Apotex Inc, first approval 19 January 2011Dr Reddys Laboratories Ltd, first approval 19 January 2011Mylan Pharmaceuticals Inc, first approval 19 January 2011Torrent Pharmaceuticals Ltd, first approval 19 January 2011Lannett Co Inc, first approval 20 January 2011Rubicon Research Ltd, first approval 2 May 2012Aurobindo Pharma Ltd, first approval 28 September 2012Hetero Labs Ltd Unit V, first approval 10 September 2014Orbion Pharmaceuticals Private Ltd, first approval 2 December 2014Amneal Pharmaceuticals, first approval 26 January 2016Mankind Pharma Ltd, first approval 26 July 2022Granules India Ltd, first approval 11 December 2023Graviti Pharmaceuticals Private Ltd, first approval 16 January 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Apotex Inc19 January 20112
Dr Reddys Laboratories Ltd19 January 20112
Mylan Pharmaceuticals Inc19 January 20112
Torrent Pharmaceuticals Ltd19 January 20112
Lannett Co Inc20 January 20112
Rubicon Research Ltd2 May 20122
Aurobindo Pharma Ltd28 September 20122
Hetero Labs Ltd Unit V10 September 20142
Orbion Pharmaceuticals Private Ltd2 December 20142
Amneal Pharmaceuticals26 January 20162
Mankind Pharma Ltd26 July 20221
Granules India Ltd11 December 20232

1 more makers are listed in the data.

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Injectable, Intravenous

Four or more generic makers listed

Brand listed as marketed: Protonix Iv. 11 generic makers with 11 generic products listed as marketed; the first generic approval is dated 8 November 2012.

2000200520102015202020252030011brand 2001Epic Pharma Llc, first approval 8 November 2012Eugia Pharma Specialities Ltd, first approval 30 March 2016Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd, first approval 30 August 2021Aspiro Pharma Ltd, first approval 18 May 2022Be Pharmaceuticals Ag, first approval 18 May 2022Gland Pharma Ltd, first approval 18 May 2022Knack Pharmaceuticals Inc, first approval 19 May 2022Meitheal Pharmaceuticals Inc, first approval 29 August 2022Alembic Pharmaceuticals Ltd, first approval 31 March 2025Deva Holding As, first approval 16 May 2025Hainan Shuangcheng Pharmaceuticals Co Ltd, first approval 22 April 2026data dateExclusivity NPP to 12 August 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Epic Pharma Llc8 November 20121
Eugia Pharma Specialities Ltd30 March 20161
Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd30 August 20211
Aspiro Pharma Ltd18 May 20221
Be Pharmaceuticals Ag18 May 20221
Gland Pharma Ltd18 May 20221
Knack Pharmaceuticals Inc19 May 20221
Meitheal Pharmaceuticals Inc29 August 20221
Alembic Pharmaceuticals Ltd31 March 20251
Deva Holding As16 May 20251
Hainan Shuangcheng Pharmaceuticals Co Ltd22 April 20261

Patents and exclusivities still listed

  • 12 August 2027Exclusivity NPP Protonix Iv

For Suspension, Delayed Release, Oral

Four or more generic makers listed

Brand listed as marketed: Protonix. 6 generic makers with 6 generic products listed as marketed; the first generic approval is dated 30 June 2020.

20052010201520202025203006brand 2007Sun Pharmaceutical Industries Ltd, first approval 30 June 2020Ajanta Pharma Ltd, first approval 9 February 2023Dexcel Pharma Technologies Ltd, first approval 16 June 2023Annora Pharma Private Ltd, first approval 27 October 2023Aurobindo Pharma Ltd, first approval 31 March 2025Cipla Ltd, first approval 31 March 2025data datePatent 7544370*PED listed to expire 7 December 2026
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sun Pharmaceutical Industries Ltd30 June 20201
Ajanta Pharma Ltd9 February 20231
Dexcel Pharma Technologies Ltd16 June 20231
Annora Pharma Private Ltd27 October 20231
Aurobindo Pharma Ltd31 March 20251
Cipla Ltd31 March 20251

Patents and exclusivities still listed

  • 7 December 2026Patent 7544370*PED

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Pantoprazole Sodium In 0.9% Sodium Chloride. No generic is listed as marketed.

20202025203001brand 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Powder, Intravenous

One to three generic makers listed

Brand listed as marketed: Pantoprazole Sodium. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 1 August 2024.

201520202025203001brand 2017Fresenius Kabi Usa Llc, first approval 1 August 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fresenius Kabi Usa Llc1 August 20241

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.