Nexium Iv is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 3 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 Mar 04, 2017. Details of Nexium 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). | |||
|
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
|
| US5877192 | Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole |
May, 2014
(10 years ago) |
Expired
|
| US6143771 | Compounds |
May, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Nexium Iv. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nexium 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 Nexium Iv.
Exclusivity Information
Nexium Iv holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Nexium Iv's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-138) | Mar 04, 2017 |
| New Indication(I-679) | Mar 04, 2017 |
US patents provide insights into the exclusivity only within the United States, but Nexium 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 Nexium Iv's family patents as well as insights into ongoing legal events on those patents.
Nexium Iv's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nexium Iv's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 04, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nexium Iv Generic API suppliers:
Esomeprazole Sodium is the generic name for the brand Nexium Iv. 7 different companies have already filed for the generic of Nexium Iv, with Gland Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nexium Iv's generic
How can I launch a generic of Nexium Iv before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nexium Iv's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nexium 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 Nexium Iv -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg/vial and 40 mg/vial | 23 Nov, 2009 | 1 | 18 Mar, 2013 | 27 May, 2014 | Deferred |
About Nexium Iv
Nexium Iv is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for short-term treatment of gastroesophageal reflux disease (GERD) when oral therapy with Nexium capsules is not possible or appropriate. Nexium Iv uses Esomeprazole Sodium as an active ingredient. Nexium Iv was launched by Astrazeneca in 2005.
Approval Date:
Nexium Iv was approved by FDA for market use on 31 March, 2005.
Active Ingredient:
Nexium Iv uses Esomeprazole Sodium as the active ingredient. Check out other Drugs and Companies using Esomeprazole Sodium ingredient
Treatment:
Nexium Iv is used for short-term treatment of gastroesophageal reflux disease (GERD) when oral therapy with Nexium capsules is not possible or appropriate.
Dosage:
Nexium Iv is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INTRAVENOUS |
| EQ 40MG BASE/VIAL | INJECTABLE | Discontinued | INTRAVENOUS |