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Last Updated: January 15, 2021

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PROTONIX IV Drug Profile

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When do Protonix Iv patents expire, and what generic alternatives are available?

Protonix Iv is a drug marketed by Wyeth Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-eight patent family members in forty countries.

The generic ingredient in PROTONIX IV is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Forty-eight 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 Iv

A generic version of PROTONIX IV was approved as pantoprazole sodium by DR REDDYS LABS LTD on January 19th, 2011.

  Start Trial

Drug patent expirations by year for PROTONIX IV
Drug Prices for PROTONIX IV

See drug prices for PROTONIX IV

Recent Clinical Trials for PROTONIX IV

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

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

See all PROTONIX IV clinical trials

Pharmacology for PROTONIX IV
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Paragraph IV (Patent) Challenges for PROTONIX IV
Tradename Dosage Ingredient NDA Submissiondate
PROTONIX IV INJECTABLE;IV (INFUSION) pantoprazole sodium 020988 2005-04-07

US Patents and Regulatory Information for PROTONIX IV

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 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 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 IV pantoprazole sodium INJECTABLE;IV (INFUSION) 020988-001 Mar 22, 2001 AP 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

Supplementary Protection Certificates for PROTONIX IV

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:

Mallinckrodt
Express Scripts
Moodys
Dow
Baxter
Harvard Business School

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