Protonix Iv is a drug owned by Wyeth Pharmaceuticals Llc. It is protected by 6 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 12, 2027. Details of Protonix Iv'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). | |||
|
US8754108 (Pediatric) | Freeze-dried pantoprazole preparation and pantoprazole injection |
May, 2022
(2 years ago) |
Expired
|
|
US6780881 (Pediatric) | Freeze-dried pantoprazole preparation and pantoprazole injection |
May, 2022
(2 years ago) |
Expired
|
|
US7351723 (Pediatric) | Freeze-dried pantoprazole preparation and pantoprazole injection |
May, 2022
(2 years ago) |
Expired
|
| US6780881 | Freeze-dried pantoprazole preparation and pantoprazole injection |
Nov, 2021
(3 years ago) |
Expired
|
| US8754108 | Freeze-dried pantoprazole preparation and pantoprazole injection |
Nov, 2021
(3 years ago) |
Expired
|
| US7351723 | Freeze-dried pantoprazole preparation and pantoprazole injection |
Nov, 2021
(3 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 Iv's patents.
Latest Legal Activities on Protonix Iv's Patents
Given below is the list of recent legal activities going on the following patents of Protonix Iv.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Dec, 2021 | US8754108 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2019 | US7351723 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Nov, 2017 | US8754108 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Jun, 2014 | US8754108 |
| Recordation of Patent Grant Mailed Critical | 17 Jun, 2014 | US8754108 |
| Issue Notification Mailed Critical | 28 May, 2014 | US8754108 |
| Dispatch to FDC | 20 May, 2014 | US8754108 |
| Printer Rush- No mailing | 15 May, 2014 | US8754108 |
| Pubs Case Remand to TC Critical | 13 May, 2014 | US8754108 |
| Application Is Considered Ready for Issue Critical | 10 May, 2014 | US8754108 |
FDA has granted several exclusivities to Protonix Iv. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Protonix Iv, 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 Iv.
Exclusivity Information
Protonix Iv holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Protonix Iv's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Aug 12, 2027 |
US patents provide insights into the exclusivity only within the United States, but Protonix Iv 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 Iv's family patents as well as insights into ongoing legal events on those patents.
Protonix Iv's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Protonix Iv's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 12, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Protonix Iv Generic API suppliers:
Pantoprazole Sodium is the generic name for the brand Protonix Iv. 37 different companies have already filed for the generic of Protonix Iv, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Protonix Iv's generic
How can I launch a generic of Protonix Iv before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Protonix Iv's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Protonix Iv'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 Iv -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg/vial | 07 Apr, 2005 | 1 | 17 Nov, 2021 | Extinguished |
Alternative Brands for Protonix Iv
There are several other brand drugs using the same active ingredient (Pantoprazole Sodium) as Protonix Iv. 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 Iv's active ingredient. Check the complete list of approved generic manufacturers for Protonix Iv
About Protonix Iv
Protonix Iv is a drug owned by Wyeth Pharmaceuticals Llc. Protonix Iv uses Pantoprazole Sodium as an active ingredient. Protonix Iv was launched by Wyeth Pharms in 2001.
Approval Date:
Protonix Iv was approved by FDA for market use on 22 March, 2001.
Active Ingredient:
Protonix Iv uses Pantoprazole Sodium as the active ingredient. Check out other Drugs and Companies using Pantoprazole Sodium ingredient
Dosage:
Protonix Iv is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE/VIAL | INJECTABLE | Prescription | INTRAVENOUS |