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 | US6147103 | Omeprazole process and compositions thereof |
Oct 09, 2018
(Expired) | Astrazeneca |
| Prilosec |
US6147103 (Pediatric) | Omeprazole process and compositions thereof |
Apr 09, 2019
(Expired) | Astrazeneca |
| Prilosec | US6150380 | Crystalline form of omeprazole |
Nov 10, 2018
(Expired) | Astrazeneca |
| Prilosec |
US6150380 (Pediatric) | Crystalline form of omeprazole |
May 10, 2019
(Expired) | Astrazeneca |
| Prilosec | US6166213 | Omeprazole process and compositions thereof |
Oct 09, 2018
(Expired) | Astrazeneca |
| Prilosec |
US6166213 (Pediatric) | Omeprazole process and compositions thereof |
Apr 09, 2019
(Expired) | Astrazeneca |
| Prilosec | US6191148 | Omerazole process and compositions thereof |
Oct 09, 2018
(Expired) | Astrazeneca |
| Prilosec |
US6191148 (Pediatric) | Omerazole process and compositions thereof |
Apr 09, 2019
(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.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 | 17 Nov, 2020 | US10835488 |
| Patent Issue Date Used in PTA Calculation | 17 Nov, 2020 | US10835488 |
| Email Notification | 29 Oct, 2020 | US10835488 |
| Issue Notification Mailed | 28 Oct, 2020 | US10835488 |
| Email Notification | 13 Oct, 2020 | US10835488 |
| Mailing Corrected Notice of Allowability | 13 Oct, 2020 | US10835488 |
| Dispatch to FDC | 10 Oct, 2020 | US10835488 |
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Omeprazole Generics
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.
1. MYLAN
Mylan Pharmaceuticals 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 Mylan.
| 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 |
2. 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
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. 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 |
12. 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 |
13. 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 |
14. 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 |
15. 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 |
16. 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 |
17. 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 |
18. 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 |