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Last Updated: July 4, 2020

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PROTONIX Drug Profile


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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 one Paragraph IV challenge.

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.

US ANDA Litigation and Generic Entry Outlook for Protonix

A generic version of PROTONIX was approved as pantoprazole sodium by TEVA on August 2nd, 2007.

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Drug patent expirations by year for PROTONIX
Drug Prices for PROTONIX

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Drug Sales Revenue Trends for PROTONIX

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Recent Clinical Trials for PROTONIX

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

SponsorPhase
Assiut UniversityPhase 1
Assiut UniversityPhase 2
University of Southern CaliforniaPhase 4

See all PROTONIX clinical trials

Pharmacology for PROTONIX
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Paragraph IV (Patent) Challenges for PROTONIX
Tradename Dosage Ingredient NDA Submissiondate
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 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 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;IV (INFUSION) 020988-001 Mar 22, 2001 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;IV (INFUSION) 020988-001 Mar 22, 2001 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 RX Yes Yes   Start Trial   Start Trial Y   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 PROTONIX

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 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
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 PROTONIX

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
0166287 96C0033 Belgium   Start Trial PRODUCT NAME: EPTACOG ALFA (ACTIVATED); REGISTRATION NO/DATE: EU/1/96/006/002 19960223
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Moodys
Harvard Business School
Medtronic
McKesson

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