Prilosec Patent Expiration

Prilosec is a drug owned by Covis Pharma Gmbh. 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 Nov 03, 2019. Details of Prilosec'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 Pharmaceutical formulation comprising omeprazole
Nov, 2019

(4 years ago)

Expired
US5900424 Omeprazole magnesium salt form
May, 2016

(8 years ago)

Expired
US5690960 Pharmaceutical formulation of omeprazole
Nov, 2014

(9 years ago)

Expired


FDA has granted several exclusivities to Prilosec. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prilosec, 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 Prilosec.

Exclusivity Information

Prilosec holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Prilosec's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Pediatric Exclusivity(PED) Sep 20, 2011

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Prilosec 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's family patents as well as insights into ongoing legal events on those patents.

Prilosec's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Prilosec's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 03, 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 Generics:

Omeprazole Magnesium is the generic name for the brand Prilosec. 18 different companies have already filed for the generic of Prilosec, with Dr Reddys Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prilosec's generic





About Prilosec

Prilosec is a drug owned by Covis Pharma Gmbh. It is used for treating gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 1-2 years. Prilosec uses Omeprazole Magnesium as an active ingredient. Prilosec was launched by Covis in 2008.

Approval Date:

Prilosec was approved by FDA for market use on 20 March, 2008.

Active Ingredient:

Prilosec uses Omeprazole Magnesium as the active ingredient. Check out other Drugs and Companies using Omeprazole Magnesium ingredient

Treatment:

Prilosec is used for treating gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 1-2 years.

Dosage:

Prilosec is available in for suspension, delayed release 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 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE Prescription ORAL


Prilosec is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 8 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 10, 2019. Details of Prilosec'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).
US6150380

(Pediatric)

Crystalline form of omeprazole
May, 2019

(5 years ago)

Expired
US6147103

(Pediatric)

Omeprazole process and compositions thereof
Apr, 2019

(5 years ago)

Expired
US6166213

(Pediatric)

Omeprazole process and compositions thereof
Apr, 2019

(5 years ago)

Expired
US6191148

(Pediatric)

Omerazole process and compositions thereof
Apr, 2019

(5 years ago)

Expired
US6150380 Crystalline form of omeprazole
Nov, 2018

(5 years ago)

Expired
US6147103 Omeprazole process and compositions thereof
Oct, 2018

(6 years ago)

Expired
US6191148 Omerazole process and compositions thereof
Oct, 2018

(6 years ago)

Expired
US6166213 Omeprazole process and compositions thereof
Oct, 2018

(6 years ago)

Expired


FDA has granted several exclusivities to Prilosec. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prilosec, 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 Prilosec.

Exclusivity Information

Prilosec holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Prilosec's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Pediatric Exclusivity(PED) Sep 20, 2011

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Prilosec 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's family patents as well as insights into ongoing legal events on those patents.

Prilosec's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Prilosec's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 10, 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 Generics:

Omeprazole is the generic name for the brand Prilosec. 18 different companies have already filed for the generic of Prilosec, with Dr Reddys Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prilosec's generic

How can I launch a generic of Prilosec before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Prilosec's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prilosec'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 -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg, 20 mg and 40 mg





About Prilosec

Prilosec is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 1-2 years. Prilosec uses Omeprazole as an active ingredient. Prilosec was launched by Astrazeneca in 1995.

Approval Date:

Prilosec was approved by FDA for market use on 05 October, 1995.

Active Ingredient:

Prilosec uses Omeprazole as the active ingredient. Check out other Drugs and Companies using Omeprazole ingredient

Treatment:

Prilosec is used for treating gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 1-2 years.

Dosage:

Prilosec is available in capsule, delayed rel pellets form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS Discontinued ORAL
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS Discontinued ORAL
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS Discontinued ORAL