Omeprazole Patent Expiration
Omeprazole was first introduced by Astrazeneca Pharmaceuticals Lp
Omeprazole Patents
Given below is the list of patents protecting Omeprazole, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Omeprazole | US10076494 | Stable orally disintegrating pharmaceutical compositions | Dec 08, 2036 | Dexcel |
| Omeprazole | US10835488 | Stable orally disintegrating pharmaceutical compositions | Dec 08, 2036 | Dexcel |
| Omeprazole | US9023391 | Stable benzimidazole formulation | Aug 16, 2025 | Dexcel Pharma |
| Prilosec |
US6150380 (Pediatric) | Crystalline form of omeprazole |
May 10, 2019
(Expired) | Astrazeneca |
| Prilosec |
US6147103 (Pediatric) | Omeprazole process and compositions thereof |
Apr 09, 2019
(Expired) | Astrazeneca |
| Prilosec |
US6166213 (Pediatric) | Omeprazole process and compositions thereof |
Apr 09, 2019
(Expired) | Astrazeneca |
| Prilosec |
US6191148 (Pediatric) | Omerazole process and compositions thereof |
Apr 09, 2019
(Expired) | Astrazeneca |
| Prilosec | US6150380 | Crystalline form of omeprazole |
Nov 10, 2018
(Expired) | Astrazeneca |
| Prilosec | US6147103 | Omeprazole process and compositions thereof |
Oct 09, 2018
(Expired) | Astrazeneca |
| Prilosec | US6166213 | Omeprazole process and compositions thereof |
Oct 09, 2018
(Expired) | Astrazeneca |
| Prilosec | US6191148 | Omerazole process and compositions thereof |
Oct 09, 2018
(Expired) | Astrazeneca |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Omeprazole's patents.
Latest Legal Activities on Omeprazole's Patents
Given below is the list recent legal activities going on the following patents of Omeprazole.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 May, 2024 | US10835488 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Oct, 2022 | US9023391(Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Feb, 2022 | US10076494 |
| Recordation of Patent Grant Mailed Critical | 17 Nov, 2020 | US10835488 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Nov, 2020 | US10835488 |
| Email Notification Critical | 29 Oct, 2020 | US10835488 |
| Issue Notification Mailed Critical | 28 Oct, 2020 | US10835488 |
| Email Notification Critical | 13 Oct, 2020 | US10835488 |
| Mailing Corrected Notice of Allowability | 13 Oct, 2020 | US10835488 |
| Dispatch to FDC | 10 Oct, 2020 | US10835488 |
Omeprazole's Family Patents
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Omeprazole Generic API Manufacturers
Several generic applications have been filed for Omeprazole. The first generic version for Omeprazole was by Lannett Co Inc and was approved on Nov 1, 2002. And the latest generic version is by Xiromed Pharma Espana Sl and was approved on Dec 10, 2020.
Given below is the list of companies who have filed for Omeprazole generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS LABS FL INC
Actavis Laboratories Fl Inc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | May 30, 2008 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | May 30, 2008 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | May 30, 2008 |
2. APOTEX
Apotex Inc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Oct 22, 2007 |
| 20MG | tablet, delayed release | Over the counter | ORAL | N/A | Feb 11, 2019 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jan 21, 2009 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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3. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Aug 19, 2015 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Aug 19, 2015 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Aug 19, 2015 |
Manufacturing Plant Locations New
Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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4. BRECKENRIDGE
Breckenridge Pharmaceutical Inc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Breckenridge.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jul 3, 2017 |
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jul 3, 2017 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jul 3, 2017 |
Manufacturing Plant Locations New
Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
| |||||
5. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Omeprazole. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | tablet, delayed release | Over the counter | ORAL | N/A | Nov 5, 2018 |
6. DR REDDYS LABS LTD
Dr Reddys Laboratories Ltd has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Mar 16, 2009 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Mar 16, 2009 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Apr 17, 2009 |
7. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Oct 31, 2014 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Oct 31, 2014 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Oct 31, 2014 |
8. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Sep 26, 2019 |
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Sep 26, 2019 |
9. IMPAX LABS
Impax Laboratories Inc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Impax Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Oct 22, 2007 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Oct 22, 2007 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jan 21, 2009 |
10. LANNETT CO INC
Lannett Co Inc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Nov 1, 2002 |
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Nov 1, 2002 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jan 23, 2009 |
11. LUPIN LTD
Lupin Ltd has filed for 1 generic for Omeprazole. Given below are the details of the strengths of this generic introduced by Lupin Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | Aug 25, 2015 |
Manufacturing Plant Locations New
Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
12. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | Jun 29, 2018 |
| 20MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | Jun 29, 2018 |
| 40MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | Jun 29, 2018 |
13. SANDOZ
Sandoz Inc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG
(reference standard) | capsule, delayed rel pellets | Prescription | ORAL | AB | Jan 28, 2003 |
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jan 28, 2003 |
| 40MG
(reference standard) | capsule, delayed rel pellets | Prescription | ORAL | AB | Jan 21, 2009 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
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| United States |
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| Spain |
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| India |
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14. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Strides Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | May 29, 2003 |
| 10MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | May 29, 2003 |
| 40MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | Jan 21, 2009 |
Manufacturing Plant Locations New
Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
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| India |
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15. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Omeprazole. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | tablet, delayed release | Over the counter | ORAL | N/A | Oct 12, 2018 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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16. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule, delayed rel pellets | Discontinued | ORAL | N/A | Jun 13, 2017 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Jun 13, 2017 |
17. XIROMED
Xiromed Pharma Espana Sl has filed for 2 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Xiromed.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Dec 10, 2020 |
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Dec 10, 2020 |
Manufacturing Plant Locations New
Xiromed's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Xiromed as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
18. ZYDUS PHARMS USA INC
Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Omeprazole. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Nov 19, 2012 |
| 40MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Nov 19, 2012 |
| 10MG | capsule, delayed rel pellets | Prescription | ORAL | AB | Nov 19, 2012 |