➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Johnson and Johnson
Moodys
Merck
Express Scripts

Last Updated: March 4, 2021

DrugPatentWatch Database Preview

Pantoprazole sodium - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, Akorn Inc, Aurobindo Pharma Ltd, Mylan Labs Ltd, Sandoz Inc, Hikma, Actavis Totowa, Amneal Pharms, Atlantide, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Rubicon, Sun Pharm Inds Ltd, Teva, and Torrent Pharms, and is included in twenty-eight 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 suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for pantoprazole sodium

See drug prices for pantoprazole sodium

Drug Sales Revenue Trends for pantoprazole sodium

See drug sales revenues for pantoprazole sodium

Recent Clinical Trials for pantoprazole sodium

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

SponsorPhase
Mansoura UniversityN/A
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
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
  Start Trial  Start Trial40MGINJECTABLE; INJECTION
  Start Trial  Start TrialEQ 40MG BASE/VIALINJECTABLE; IV (INFUSION)

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 NDA Submissiondate
PROTONIX IV INJECTABLE;IV (INFUSION) pantoprazole sodium 020988 2005-04-07
PROTONIX TABLET, DELAYED RELEASE;ORAL pantoprazole sodium 020987 2004-02-02
PROTONIX FOR SUSPENSION, DELAYED RELEASE;ORAL pantoprazole sodium 022020

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
Akorn Inc PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;IV (INFUSION) 079197-001 Nov 8, 2012 AP RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202052-001 Dec 2, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 077619-001 Jan 19, 2011 AB RX No No   Start Trial   Start Trial   Start 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 020987-002 Jun 12, 2001   Start Trial   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007   Start Trial   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000   Start Trial   Start 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   Start 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   Start 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Merck
Johnson and Johnson
McKinsey
Medtronic
Boehringer Ingelheim

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.