Nexium 24hr is a drug owned by Astrazeneca Lp. It is protected by 16 US drug patents filed from 2014 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 03, 2020. Details of Nexium 24hr's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6369085 | Form of S-omeprazole |
May, 2018
(6 years ago) |
Expired
|
| US7411070 | Form of S-omeprazole |
May, 2018
(6 years ago) |
Expired
|
| US5900424 | Omeprazole magnesium salt form |
May, 2016
(8 years ago) |
Expired
|
| US6875872 | Compounds |
May, 2014
(10 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6428810 (Pediatric) | Pharmaceutical formulation comprising omeprazole |
May, 2020
(4 years ago) |
Expired
|
| US6428810 | Pharmaceutical formulation comprising omeprazole |
Nov, 2019
(5 years ago) |
Expired
|
|
US6369085 (Pediatric) | Form of S-omeprazole |
Nov, 2018
(6 years ago) |
Expired
|
|
US7411070 (Pediatric) | Form of S-omeprazole |
Nov, 2018
(6 years ago) |
Expired
|
|
US5900424 (Pediatric) | Omeprazole magnesium salt form |
Nov, 2016
(8 years ago) |
Expired
|
|
US5714504 (Pediatric) | Compositions |
Aug, 2015
(9 years ago) |
Expired
|
|
US5690960 (Pediatric) | Pharmaceutical formulation of omeprazole |
May, 2015
(9 years ago) |
Expired
|
| US5714504 | Compositions |
Feb, 2015
(9 years ago) |
Expired
|
|
US6875872 (Pediatric) | Compounds |
Nov, 2014
(10 years ago) |
Expired
|
|
US5877192 (Pediatric) | Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole |
Nov, 2014
(10 years ago) |
Expired
|
| US5690960 | Pharmaceutical formulation of omeprazole |
Nov, 2014
(10 years ago) |
Expired
|
| US5877192 | Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole |
May, 2014
(10 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 Nexium 24hr's patents.
Latest Legal Activities on Nexium 24hr's Patents
Given below is the list of recent legal activities going on the following patents of Nexium 24hr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 14 Sep, 2020 | US7411070 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 30 Mar, 2020 | US7411070 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Aug, 2008 | US7411070 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 12 Aug, 2008 | US7411070 (Litigated) |
| Issue Notification Mailed Critical | 23 Jul, 2008 | US7411070 (Litigated) |
| Dispatch to FDC | 17 Jul, 2008 | US7411070 (Litigated) |
| Printer Rush- No mailing | 17 Jul, 2008 | US7411070 (Litigated) |
| Application Is Considered Ready for Issue Critical | 17 Jul, 2008 | US7411070 (Litigated) |
| Pubs Case Remand to TC Critical | 16 Jul, 2008 | US7411070 (Litigated) |
| Printer Rush- No mailing | 30 Jun, 2008 | US7411070 (Litigated) |
FDA has granted several exclusivities to Nexium 24hr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nexium 24hr, 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 Nexium 24hr.
Exclusivity Information
Nexium 24hr holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Nexium 24hr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| RTO(RTO) | Mar 28, 2017 |
US patents provide insights into the exclusivity only within the United States, but Nexium 24hr 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 Nexium 24hr's family patents as well as insights into ongoing legal events on those patents.
Nexium 24hr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nexium 24hr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 03, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nexium 24hr Generic API suppliers:
Esomeprazole Magnesium is the generic name for the brand Nexium 24hr. 30 different companies have already filed for the generic of Nexium 24hr, with Hetero Labs Ltd Iii having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nexium 24hr's generic
How can I launch a generic of Nexium 24hr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nexium 24hr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nexium 24hr'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 Nexium 24hr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg | 24 Apr, 2014 | ||||
| 20 mg | 09 Sep, 2016 | 1 | 05 Mar, 2019 | 03 Nov, 2019 | Eligible |
Alternative Brands for Nexium 24hr
Nexium 24hr which is used for treating frequent heartburn., has several other brand drugs using the same active ingredient (Esomeprazole Magnesium). 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 | |
|---|---|---|
| Astrazeneca |
| |
| Dexcel |
| |
| Horizon |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Esomeprazole Magnesium, Nexium 24hr's active ingredient. Check the complete list of approved generic manufacturers for Nexium 24hr
About Nexium 24hr
Nexium 24Hr is a drug owned by Astrazeneca Lp. It is used for treating frequent heartburn. Nexium 24Hr uses Esomeprazole Magnesium as an active ingredient. Nexium 24Hr was launched by Astrazeneca Lp in 2015.
Approval Date:
Nexium 24hr was approved by FDA for market use on 23 November, 2015.
Active Ingredient:
Nexium 24hr uses Esomeprazole Magnesium as the active ingredient. Check out other Drugs and Companies using Esomeprazole Magnesium ingredient
Treatment:
Nexium 24hr is used for treating frequent heartburn.
Dosage:
Nexium 24hr is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | CAPSULE, DELAYED RELEASE | Over the counter | ORAL |