Nexium is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 24 US drug patents filed in 2013 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'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). | |||
|
US6428810 (Pediatric) | Pharmaceutical formulation comprising omeprazole |
May, 2020
(5 years ago) |
Expired
|
| US6428810 | Pharmaceutical formulation comprising omeprazole |
Nov, 2019
(5 years ago) |
Expired
|
|
US6191148 (Pediatric) | Omerazole process and compositions thereof |
Apr, 2019
(6 years ago) |
Expired
|
|
US6166213 (Pediatric) | Omeprazole process and compositions thereof |
Apr, 2019
(6 years ago) |
Expired
|
|
US6147103 (Pediatric) | Omeprazole process and compositions thereof |
Apr, 2019
(6 years ago) |
Expired
|
|
US8466175 (Pediatric) | Form of S-omeprazole |
Nov, 2018
(6 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
|
| US6166213 | Omeprazole process and compositions thereof |
Oct, 2018
(7 years ago) |
Expired
|
| US6191148 | Omerazole process and compositions thereof |
Oct, 2018
(7 years ago) |
Expired
|
| US6147103 | Omeprazole process and compositions thereof |
Oct, 2018
(7 years ago) |
Expired
|
| US8466175 | Form of S-omeprazole |
May, 2018
(7 years ago) |
Expired
|
| US6369085 | Form of S-omeprazole |
May, 2018
(7 years ago) |
Expired
|
| US7411070 | Form of S-omeprazole |
May, 2018
(7 years ago) |
Expired
|
|
US5900424 (Pediatric) | Omeprazole magnesium salt form |
Nov, 2016
(8 years ago) |
Expired
|
| US5900424 | Omeprazole magnesium salt form |
May, 2016
(9 years ago) |
Expired
|
|
US5714504 (Pediatric) | Compositions |
Aug, 2015
(10 years ago) |
Expired
|
|
US5690960 (Pediatric) | Pharmaceutical formulation of omeprazole |
May, 2015
(10 years ago) |
Expired
|
| US5714504 | Compositions |
Feb, 2015
(10 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
(11 years ago) |
Expired
|
| US6875872 | Compounds |
May, 2014
(11 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's patents.
Latest Legal Activities on Nexium's Patents
Given below is the list of recent legal activities going on the following patents of Nexium.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 26 Jul, 2021 | US8466175 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 08 Feb, 2021 | US8466175 (Litigated) |
| Expire Patent
Critical | 14 Sep, 2020 | US7411070 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 30 Mar, 2020 | US7411070 (Litigated) |
| Recordation of Patent Grant Mailed
Critical | 18 Jun, 2013 | US8466175 (Litigated) |
| Patent Issue Date Used in PTA Calculation
Critical | 18 Jun, 2013 | US8466175 (Litigated) |
| Issue Notification Mailed
Critical | 29 May, 2013 | US8466175 (Litigated) |
| Dispatch to FDC | 22 May, 2013 | US8466175 (Litigated) |
| Application Is Considered Ready for Issue
Critical | 21 May, 2013 | US8466175 (Litigated) |
| Issue Fee Payment Verified
Critical | 20 May, 2013 | US8466175 (Litigated) |
FDA has granted several exclusivities to Nexium. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Nexium, 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.
Exclusivity Information
Nexium holds 2 exclusivities. All of its exclusivities have expired in 2012. Details of Nexium's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-86) | Jun 18, 2012 |
| Pediatric Exclusivity(PED) | Dec 18, 2012 |
US patents provide insights into the exclusivity only within the United States, but
Nexium 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's family patents as well as insights into
ongoing legal events
on those patents.
Nexium's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nexium'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 Generic API suppliers:
Esomeprazole Magnesium is the generic name for the brand Nexium. 29 different companies have already filed for the generic of Nexium, with Cipla having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nexium's generic
How can I launch a generic of Nexium before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nexium's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nexium'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg and 40 mg | 05 Aug, 2005 | 1 | 01 Mar, 2008 | Extinguished | |
| 20 mg and 40 mg | 01 Aug, 2013 | 1 | 03 Nov, 2019 | Extinguished | |
| 10 mg | 06 Jul, 2018 | 1 | 23 Mar, 2020 | 03 Nov, 2019 | Extinguished |
| 2.5 mg and 5 mg | 24 Sep, 2018 | 1 | 03 Nov, 2019 | Extinguished |
Alternative Brands for Nexium
Nexium which is used for treating GERD, eradicating H. pylori, and reducing the risk of duodenal ulcer recurrence., 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 Lp |
| |
| Dexcel |
| |
| Horizon |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Esomeprazole Magnesium, Nexium's active ingredient. Check the complete list of approved generic manufacturers for Nexium
About Nexium
Nexium is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating GERD, eradicating H. pylori, and reducing the risk of duodenal ulcer recurrence. Nexium uses Esomeprazole Magnesium as an active ingredient. Nexium was launched by Astrazeneca in 2008.
Approval Date:
Nexium was approved by FDA for market use on 27 February, 2008.
Active Ingredient:
Nexium uses Esomeprazole Magnesium as the active ingredient. Check out other Drugs and Companies using Esomeprazole Magnesium ingredient
Treatment:
Nexium is used for treating GERD, eradicating H. pylori, and reducing the risk of duodenal ulcer recurrence.
Dosage:
Nexium is available in the following dosage forms - for suspension, delayed release form for oral use, capsule, delayed rel pellets form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE | Prescription | ORAL |
| EQ 20MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE | Prescription | ORAL |
| EQ 40MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE | Prescription | ORAL |
| EQ 2.5MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE | Prescription | ORAL |
| EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS | Prescription | ORAL |
| EQ 5MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE | Prescription | ORAL |
| EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS | Prescription | ORAL |