Prilosec Otc Patent Expiration

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

(4 years ago)

Expired
US6428810 Pharmaceutical formulation comprising omeprazole
Nov, 2019

(4 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

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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


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 Generics:

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
Nexium
Astrazeneca Lp
Nexium 24hr
Covis
Prilosec
Dexcel
Esomeprazole Magnesium
Horizon
Vimovo
Redhill
Talicia


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