Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Colorcon
Medtronic
Johnson and Johnson
Baxter

Last Updated: May 24, 2022

PROTONIX Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

Which patents cover Protonix, and when can generic versions of Protonix launch?

Protonix is a drug marketed by Wyeth Pharms and is included in three NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in twenty-eight countries.

The generic ingredient in PROTONIX is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Drug patent expirations by year for PROTONIX
Drug Prices for PROTONIX

See drug prices for PROTONIX

Drug Sales Revenue Trends for PROTONIX

See drug sales revenues for PROTONIX

Recent Clinical Trials for PROTONIX

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

SponsorPhase
PfizerPhase 2
Mirati Therapeutics Inc.Phase 1
Assiut UniversityPhase 2

See all PROTONIX clinical trials

Paragraph IV (Patent) Challenges for PROTONIX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROTONIX for Delayed-release Oral Suspension pantoprazole sodium 40 mg 022020 1 2019-09-13
PROTONIX Delayed-release Tablets pantoprazole sodium 20 mg and 40 mg 020987 2004-02-02

US Patents and Regulatory Information for PROTONIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;INTRAVENOUS 020988-001 Mar 22, 2001 AP RX Yes Yes 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
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;INTRAVENOUS 020988-001 Mar 22, 2001 AP RX Yes Yes 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
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
>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 PROTONIX

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 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 020987-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PROTONIX

See the table below for patents covering PROTONIX around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 86894 Dialkoxyridines, process for their preparation, their application and medicaments containing them See Plans and Pricing
Ireland 851478 See Plans and Pricing
Czechoslovakia 9103964 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9222284 See Plans and Pricing
Norway 20061471 See Plans and Pricing
Australia 683411 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROTONIX

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 96C0033 Belgium See Plans and Pricing PRODUCT NAME: EPTACOG ALFA (ACTIVATED); REGISTRATION NO/DATE: EU/1/96/006/002 19960223
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

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Moodys
Harvard Business School
Medtronic
McKesson

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.