Prilosec Otc is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 6 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 Nov 15, 2019. Details of Prilosec Otc'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). | |||
| US6403616 | Chemical process and pharmaceutical formulation |
Nov, 2019
(5 years ago) |
Expired
|
| US6428810 | Pharmaceutical formulation comprising omeprazole |
Nov, 2019
(5 years ago) |
Expired
|
| US5900424 | Omeprazole magnesium salt form |
May, 2016
(8 years ago) |
Expired
|
| US5817338 | Multiple unit tableted dosage form of omeprazole |
Oct, 2015
(9 years ago) |
Expired
|
| US5753265 | Multiple unit pharmaceutical preparation |
Jun, 2015
(9 years ago) |
Expired
|
| US5690960 | Pharmaceutical formulation of omeprazole |
Nov, 2014
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Prilosec Otc 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 Prilosec Otc's family patents as well as insights into ongoing legal events on those patents.
Prilosec Otc's Family Patents
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Generic Launch
Generic Release Date:
Prilosec Otc's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 15, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prilosec Otc Generic API suppliers:
Omeprazole Magnesium is the generic name for the brand Prilosec Otc. 8 different companies have already filed for the generic of Prilosec Otc, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prilosec Otc's generic
How can I launch a generic of Prilosec Otc before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prilosec Otc's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prilosec Otc'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 Prilosec Otc -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg | 19 Mar, 2007 | 1 | 05 Jun, 2009 | 15 Nov, 2019 | Eligible |
| 20 mg | 30 Mar, 2012 | 1 | 30 Jul, 2015 | 15 Nov, 2019 | Eligible |
Alternative Brands for Prilosec Otc
There are several other brand drugs using the same active ingredient (Omeprazole Magnesium) as Prilosec Otc. 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 |
| |
| Astrazeneca Lp |
| |
| Covis |
| |
| Dexcel |
| |
| Horizon |
| |
| Redhill |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Omeprazole Magnesium, Prilosec Otc's active ingredient. Check the complete list of approved generic manufacturers for Prilosec Otc
About Prilosec Otc
Prilosec Otc is a drug owned by Astrazeneca Pharmaceuticals Lp. Prilosec Otc uses Omeprazole Magnesium as an active ingredient. Prilosec Otc was launched by Astrazeneca in 2003.
Approval Date:
Prilosec Otc was approved by FDA for market use on 20 June, 2003.
Active Ingredient:
Prilosec Otc uses Omeprazole Magnesium as the active ingredient. Check out other Drugs and Companies using Omeprazole Magnesium ingredient
Dosage:
Prilosec Otc is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET, DELAYED RELEASE | Over the counter | ORAL |