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Last Updated: May 21, 2022

PROTONIX IV Drug Patent 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 and one Paragraph IV challenge.

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. Fifty-two suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Protonix Iv

A generic version of PROTONIX IV was approved as pantoprazole sodium by ATLANTIDE on January 19th, 2011.

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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
PfizerPhase 2
Mirati Therapeutics Inc.Phase 1
Assiut UniversityPhase 2

See all PROTONIX IV clinical trials

Paragraph IV (Patent) Challenges for PROTONIX IV
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROTONIX IV For Injection pantoprazole sodium 40 mg/vial 020988 1 2005-04-07

US Patents and Regulatory Information for PROTONIX IV

PROTONIX IV is protected by two US patents.

Patents protecting PROTONIX IV

Freeze-dried pantoprazole preparation and pantoprazole injection
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Freeze-dried pantoprazole preparation and pantoprazole injection
Patent Number: See Plans and Pricing
Patent Expiration: 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
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 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 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
>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 IV

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

International Patents for PROTONIX IV

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

Country Patent Number Title Estimated Expiration
Iceland 6820 See Plans and Pricing
Japan S6122079 DIALKOXYPYRIDINE, MANUFACTURE, USE AND DRUG See Plans and Pricing
China 1250292 See Plans and Pricing
Spain 2298295 See Plans and Pricing
Australia 578703 See Plans and Pricing
Mexico PA03004548 PREPARACION LIOFILIZADA DE PANTOPRAZOLA E INYECCION DE PANTOPRAZOLA. (FREEZE-DRIED PANTOPRAZOLE PREPARATION AND PANTOPRAZOLE INJECTION.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROTONIX IV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>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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