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Last Updated: March 28, 2024

Pantoprazole sodium - Generic Drug Details


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What are the generic drug sources for pantoprazole sodium and what is the scope of freedom to operate?

Pantoprazole sodium is the generic ingredient in three branded drugs marketed by Ajanta Pharma Ltd, Annora Pharma, Dexcel, Sun Pharm, Wyeth Pharms, Acic Pharms, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Knack, Meitheal, Mylan Labs Ltd, Sandoz, Hikma, Actavis Totowa, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mankind Pharma, Mylan Pharms Inc, Orbion Pharms, Rubicon, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Wockhardt Bio Ag, and is included in thirty-nine NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pantoprazole sodium has thirty-five patent family members in twenty-eight countries.

There are forty-eight drug master file entries for pantoprazole sodium. Sixty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for pantoprazole sodium

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Drug Sales Revenue Trends for pantoprazole sodium

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Recent Clinical Trials for pantoprazole sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alexandria UniversityPhase 3
Mansoura UniversityPhase 1/Phase 2
Federal University of São PauloPhase 4

See all pantoprazole sodium clinical trials

Generic filers with tentative approvals for PANTOPRAZOLE SODIUM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial40MGINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a TrialEQ 40MG BASE/VIALPOWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pantoprazole sodium
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Paragraph IV (Patent) Challenges for PANTOPRAZOLE SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROTONIX for Delayed-release Oral Suspension pantoprazole sodium 40 mg 022020 1 2019-09-13
PROTONIX IV For Injection pantoprazole sodium 40 mg/vial 020988 1 2005-04-07
PROTONIX Delayed-release Tablets pantoprazole sodium 20 mg and 40 mg 020987 2004-02-02

US Patents and Regulatory Information for pantoprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Granules PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 217282-001 Dec 11, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202038-001 Sep 28, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 200794-002 May 2, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 077619-001 Jan 19, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;INTRAVENOUS 020988-001 Mar 22, 2001 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for pantoprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;INTRAVENOUS 020988-001 Mar 22, 2001 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for pantoprazole sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0166287 96C0032 Belgium ⤷  Try a Trial PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
0166287 SPC/GB96/056 United Kingdom ⤷  Try a Trial PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.