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.

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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 US12599565 Stable Benzimidazole Formulation Jan 31, 2030 Dexcel Pharma
Omeprazole US9023391 Stable benzimidazole formulation Aug 16, 2025

(Expired)

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, 8th Year, Large Entity 11 Mar, 2026 US10076494
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
Mailing Corrected Notice of Allowability 13 Oct, 2020 US10835488
Email Notification 13 Oct, 2020 US10835488


About Veterinary Omeprazole

Omeprazole is used in drugs marketed by 2 different companies: Bimeda Animal Health Ltd, Boehringer Lngelheim Animal Health Usa Inc.

Other drugs containing Omeprazole are: Gastrogard , Gastrobim , Ulcergard .

Omeprazole Petitions

Details of Omeprazole's suitability petitions are listed below.

Petitioner Action Date of Action Description
Suitability Petitions
Aurora Pharmaceutical, LLC Denied
Dinsmore & Shohl, LLP Approved
Precision Consultants, Inc. Denied
Intervet, Inc. Approved

Omeprazole's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Omeprazole:

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.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy Duke University NA COMPLETED
(Aug 1, 2026)
PHASE1, PHASE2
Esomeprazole and Radiation Induced Esophagitis Rush University Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Given Orally Compared With Placebo in Healthy Participants Aged 18 to 55 Years Actio Biosciences, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer Genentech, Inc. NA TERMINATED
(Aug 1, 2026)
PHASE1
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis. AstraZeneca NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism Ottawa Hospital Research Institute NA RECRUITING
(Jul 1, 2026)
PHASE3
A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers Nurix Therapeutics, Inc. NA COMPLETED
(Jul 1, 2026)
PHASE1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination Basilea Pharmaceutica NA RECRUITING
(Jul 1, 2026)
PHASE1
A Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole Enteric-Coated Tablets on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants Abbisko Therapeutics Co, Ltd NA RECRUITING
(Jul 1, 2026)
PHASE1
A Study of Esomeprazole in Children With Autism Stanford University NA RECRUITING
(Jun 1, 2026)
PHASE2
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM) Gilead Sciences NA RECRUITING
(Jun 1, 2026)
PHASE1
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders Biao Zou NA TERMINATED
(May 1, 2026)
PHASE3
Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease Indonesia University NA COMPLETED
(May 1, 2026)
PHASE3
A Multiple Dose Study of LY3502970 in Healthy Participants Eli Lilly and Company NA COMPLETED
(Apr 15, 2026)
PHASE1
PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease Universidad Autonoma de Nuevo Leon NA RECRUITING
(Apr 1, 2026)
PHASE2


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 27, 2024.

Given below is the list of companies who have filed for Omeprazole generic, along with the locations of their manufacturing plants worldwide.