You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

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 four 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. Sixty-seven suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Protonix

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

  Try a Trial

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

Pharmacology for PROTONIX
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;INTRAVENOUS 020988-001 Mar 22, 2001 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ⤷  Try a Trial ⤷  Try a 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 SPC/GB96/056 United Kingdom ⤷  Try a Trial PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604
0166287 96C0032 Belgium ⤷  Try a Trial PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
0166287 96C0033 Belgium ⤷  Try a 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

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

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.