Protonix is a drug owned by Wyeth Pharmaceuticals Llc. It is protected by 10 US drug patents filed in 2013. Out of these, 5 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 07, 2026. Details of Protonix's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7544370 (Pediatric) | Pantoprazole multiparticulate formulations |
Dec, 2026
(1 year, 11 months from now) | Active |
| US7544370 | Pantoprazole multiparticulate formulations |
Jun, 2026
(1 year, 5 months from now) | Active |
|
US7553498 (Pediatric) | Pantoprazole multiparticulate formulations |
Mar, 2025
(3 months from now) | Active |
|
US7550153 (Pediatric) | Pantoprazole multiparticulate formulations |
Mar, 2025
(3 months from now) | Active |
|
US7838027 (Pediatric) | Pantoprazole multiparticulate formulations |
Mar, 2025
(3 months from now) | Active |
| US7550153 | Pantoprazole multiparticulate formulations |
Sep, 2024
(2 months ago) |
Expired
|
| US7553498 | Pantoprazole multiparticulate formulations |
Sep, 2024
(2 months ago) |
Expired
|
| US7838027 | Pantoprazole multiparticulate formulations |
Sep, 2024
(2 months ago) |
Expired
|
|
US5997903 (Pediatric) | Oral-administration forms of a medicament containing pantoprazol |
Jun, 2017
(7 years ago) |
Expired
|
| US5997903 | Oral-administration forms of a medicament containing pantoprazol |
Dec, 2016
(8 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Protonix's patents.
Latest Legal Activities on Protonix's Patents
Given below is the list of recent legal activities going on the following patents of Protonix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2022 | US7838027 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Sep, 2020 | US7553498 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Sep, 2020 | US7544370 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Sep, 2020 | US7550153 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Apr, 2018 | US7838027 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Jul, 2016 | US7544370 |
| Email Notification Critical | 01 Jul, 2016 | US7544370 |
| Email Notification Critical | 01 Jul, 2016 | US7550153 |
| Email Notification Critical | 01 Jul, 2016 | US7553498 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Jul, 2016 | US7550153 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Protonix and ongoing litigations to help you estimate the early arrival of Protonix generic.
Protonix's Litigations
Protonix been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 10, 1996, against patent number US5997903. The petitioner , challenged the validity of this patent, with DIETRICH et al as the respondent. Click below to track the latest information on how companies are challenging Protonix's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5997903 | June, 1996 |
Decision
(04 Jul, 1776) | DIETRICH et al | |
FDA has granted some exclusivities to Protonix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Protonix, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Protonix.
Exclusivity Information
Protonix holds 3 exclusivities. All of its exclusivities have expired in 2013. Details of Protonix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-614) | Nov 12, 2012 |
| M(M-54) | Nov 12, 2012 |
| Pediatric Exclusivity(PED) | May 12, 2013 |
US patents provide insights into the exclusivity only within the United States, but Protonix is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Protonix's family patents as well as insights into ongoing legal events on those patents.
Protonix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Protonix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 07, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Protonix Generic API suppliers:
Pantoprazole Sodium is the generic name for the brand Protonix. 34 different companies have already filed for the generic of Protonix, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Protonix's generic
How can I launch a generic of Protonix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Protonix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Protonix's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Protonix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg and 40 mg | 02 Feb, 2004 | ||||
| 40 mg | 13 Sep, 2019 | 1 | 30 Jun, 2020 | 07 Jun, 2026 | Eligible |
Alternative Brands for Protonix
Protonix which is used for treating conditions associated with high stomach acid production, such as erosive esophagitis and Zollinger-Ellison syndrome., has several other brand drugs using the same active ingredient (Pantoprazole Sodium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Wyeth Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pantoprazole Sodium, Protonix's active ingredient. Check the complete list of approved generic manufacturers for Protonix
About Protonix
Protonix is a drug owned by Wyeth Pharmaceuticals Llc. It is used for treating conditions associated with high stomach acid production, such as erosive esophagitis and Zollinger-Ellison syndrome. Protonix uses Pantoprazole Sodium as an active ingredient. Protonix was launched by Wyeth Pharms in 2007.
Approval Date:
Protonix was approved by FDA for market use on 14 November, 2007.
Active Ingredient:
Protonix uses Pantoprazole Sodium as the active ingredient. Check out other Drugs and Companies using Pantoprazole Sodium ingredient
Treatment:
Protonix is used for treating conditions associated with high stomach acid production, such as erosive esophagitis and Zollinger-Ellison syndrome.
Dosage:
Protonix is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | TABLET, DELAYED RELEASE | Prescription | ORAL |
| EQ 20MG BASE | TABLET, DELAYED RELEASE | Prescription | ORAL |