Omeprazole Patent Expiration

Omeprazole was first introduced by Astrazeneca Pharmaceuticals Lp in its drug Prilosec on Sep 14, 1989. Another drug containing Omeprazole is Omeprazole. 21 different companies have introduced drugs containing Omeprazole.


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.

Given below is the list recent legal activities going on the following patents of Omeprazole.

Activity Date Patent Number
Patent litigations
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


Omeprazole's Family Patents

Family Patents

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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. 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


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


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


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


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


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


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


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


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