Prilosec is a drug owned by Azurity Pharmaceuticals Inc. 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
(6 years ago) |
Expired
|
| US5900424 | Omeprazole magnesium salt form |
May, 2016
(10 years ago) |
Expired
|
| US5690960 | Pharmaceutical formulation of omeprazole |
Nov, 2014
(11 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 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Prilosec:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
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
Alternative Brands for Prilosec
Prilosec which is used for treating gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 1-2 years., has several other brand drugs using the same active ingredient (Omeprazole 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 |
| |||
| Astrazeneca Lp |
| |||
| Azurity |
| |||
| Dexcel |
| |||
| Dexcel Pharma |
| |||
| Genus Lifesciences |
| |||
| Horizon |
| |||
| Riley Consumer |
| |||
| Salix |
| |||
| Santarus |
| |||
| Talicia Holdings |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Omeprazole Magnesium, Prilosec's active ingredient. Check the complete list of approved generic manufacturers for Prilosec
About Prilosec
Prilosec is a drug owned by Azurity Pharmaceuticals Inc. 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 Azurity 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 2.5MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE | Prescription | ORAL |
| EQ 10MG 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
(7 years ago) |
Expired
|
|
US6191148 (Pediatric) | Omerazole process and compositions thereof |
Apr, 2019
(7 years ago) |
Expired
|
|
US6166213 (Pediatric) | Omeprazole process and compositions thereof |
Apr, 2019
(7 years ago) |
Expired
|
|
US6147103 (Pediatric) | Omeprazole process and compositions thereof |
Apr, 2019
(7 years ago) |
Expired
|
| US6150380 | Crystalline form of omeprazole |
Nov, 2018
(7 years ago) |
Expired
|
| US6191148 | Omerazole process and compositions thereof |
Oct, 2018
(7 years ago) |
Expired
|
| US6166213 | Omeprazole process and compositions thereof |
Oct, 2018
(7 years ago) |
Expired
|
| US6147103 | Omeprazole process and compositions thereof |
Oct, 2018
(7 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 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Prilosec:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None |
Alternative Brands for Prilosec
Prilosec which is used for treating gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 1-2 years., has several other brand drugs using the same active ingredient (Omeprazole). 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 |
| |||
| Azurity |
| |||
| Dexcel |
| |||
| Dexcel Pharma |
| |||
| Genus Lifesciences |
| |||
| Horizon |
| |||
| Riley Consumer |
| |||
| Salix |
| |||
| Santarus |
| |||
| Talicia Holdings |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Omeprazole, Prilosec's active ingredient. Check the complete list of approved generic manufacturers for Prilosec
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 |
|---|---|---|---|
| 10MG **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 |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED REL PELLETS | Discontinued | ORAL |