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Last Updated: December 2, 2022

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 Sun Pharm, Wyeth Pharms, Acic Pharms, Akorn, Aspiro, Be Pharms, Eugia Pharma, Gland Pharma Ltd, Knack, Mylan Labs Ltd, Nanjing King-friend, Sandoz Inc, Hikma, Actavis Totowa, Amneal Pharms, Atlantide, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, 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, and Torrent Pharms, and is included in thirty-five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pantoprazole sodium has ninety-three patent family members in forty-five countries.

There are forty-eight drug master file entries for pantoprazole sodium. Fifty-six 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
See Plans and PricingSee Plans and Pricing40MGINJECTABLE; INJECTION
See Plans and PricingSee Plans and PricingEQ 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
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
Knack PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;INTRAVENOUS 214680-001 May 19, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;INTRAVENOUS 090296-001 Jul 14, 2015 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nanjing King-friend PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;INTRAVENOUS 215860-001 Aug 29, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm Inds Ltd PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 200794-001 May 2, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 IV pantoprazole sodium INJECTABLE;INTRAVENOUS 020988-001 Mar 22, 2001 See Plans and Pricing See Plans and Pricing
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;INTRAVENOUS 020988-001 Mar 22, 2001 See Plans and Pricing See Plans and Pricing
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 See Plans and Pricing See Plans and Pricing
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 See Plans and Pricing See Plans and Pricing
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000 See Plans and Pricing See Plans and Pricing
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000 See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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.