FDA Orange Book · active-ingredient family
Pantoprazole sodium
Pantoprazole sodium: 5 brands, 42 generics; first approved Feb 02, 2000; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 42 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
5
Generics (ANDA)
42
Listed patents
2
Next patent expiry
Jun 07, 2026
3 mo ago
Brand (NDA) products
Originator applications
- BAXTER HLTHCARE CORPNDA 21751220243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) SOLUTION INTRAVENOUS Rx — - PANTOPRAZOLE SODIUMRLDRSHIKMANDA 2094632017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL POWDER INTRAVENOUS Rx AP - WYETH PHARMSNDA 0220202007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - PROTONIXRLDWYETH PHARMSNDA 02098720012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - WYETH PHARMSNDA 0209882001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP
Generic (ANDA) products (42)
Abbreviated applications
- PANTOPRAZOLE SODIUMSHUANGCHENGANDA 2199732026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMDEVA HOLDING ASANDA 2150742025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMAUROBINDO PHARMA LTDANDA 2179232025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMCIPLAANDA 2174582025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMALEMBICANDA 2192302025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMGRAVITI PHARMSANDA 21908720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMFRESENIUS KABI USAANDA 2160212024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL POWDER INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMMANKIND PHARMAANDA 21588020242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMGRANULESANDA 21728220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMANNORA PHARMAANDA 2161392023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMDEXCELANDA 2162472023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMAJANTA PHARMA LTDANDA 2174162023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMMEITHEALANDA 2158602022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMKNACKANDA 2146802022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMASPIROANDA 2137782022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMBE PHARMSANDA 2161712022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMGLANDANDA 2044002022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMHANGZHOU ZHONGMEIANDA 2095242021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMSUN PHARMANDA 2137252020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMSUN PHARMANDA 0776742019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — - PANTOPRAZOLE SODIUMINGENUS PHARMS LLCANDA 2113682019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMPHARMOBEDIENTANDA 2085802018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — - PANTOPRAZOLE SODIUMEUGIA PHARMAANDA 2056752016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMAMNEAL PHARMSANDA 20511920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMSANDOZANDA 0902962015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — - PANTOPRAZOLE SODIUMORBION PHARMSANDA 20205220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMHETERO LABS LTD VANDA 20288220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUML PERRIGO COANDA 2030242014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMEPIC PHARMA LLCANDA 0791972012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - PANTOPRAZOLE SODIUMAUROBINDO PHARMA LTDANDA 20203820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMRUBICON RESEARCHANDA 09080720122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMSUN PHARM INDS LTDANDA 20079420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMMACLEODS PHARMS LTDANDA 20082120122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMJUBILANT GENERICSANDA 09090120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMACTAVIS TOTOWAANDA 09079720112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMLANNETT CO INCANDA 07828120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMAPOTEXANDA 09123120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMDR REDDYS LABS LTDANDA 07761920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMMYLAN PHARMS INCANDA 09097020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMTORRENT PHARMSANDA 09007420112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - PANTOPRAZOLE SODIUMSUN PHARMANDA 07705820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - PANTOPRAZOLE SODIUMTEVAANDA 07705620072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 40MG BASE TABLET, DELAYED RELEASE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPPNew patient population exclusivity (3 years)
in 1 yr
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7544370 | 3 mo ago | Product | |
| 7544370*PED | in 4 mo |
Approval history
FDA approval span
First approval
26 yr 11 mo ago
Most recent approval
4 mo ago
Approvals span 2000–2026 across 47 FDA applications.
Brand (NDA) 511%
Generic (ANDA) 4289%
Pantoprazole sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
