Omeprazole is a drug owned by Dexcel Pharma Technologies Ltd. It is protected by 4 US drug patents filed from 2015 to 2026. Out of these, 3 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 08, 2036. Details of Omeprazole'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). | |||
| US10835488 | Stable orally disintegrating pharmaceutical compositions |
Dec, 2036
(10 years from now) | Active |
| US10076494 | Stable orally disintegrating pharmaceutical compositions |
Dec, 2036
(10 years from now) | Active |
| US12599565 | Stable Benzimidazole Formulation |
Jan, 2030
(3 years from now) | Active |
| US9023391 | Stable benzimidazole formulation |
Aug, 2025
(1 year, 2 months ago) |
Expired
|
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 of recent legal activities going on the following patents of Omeprazole.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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
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 |
| Mailing Corrected Notice of Allowability | 13 Oct, 2020 | US10835488 |
| Email Notification
Critical | 13 Oct, 2020 | US10835488 |
US patents provide insights into the exclusivity only within the United States, but
Omeprazole 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 Omeprazole's family patents as well as insights into
ongoing legal events
on those patents.
Omeprazole's Family Patents
Explore Our Curated Drug Screens
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.
Generic Launch
Generic Release Date:
Omeprazole's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 08, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Omeprazole Generic API suppliers:
Omeprazole is the generic name for the brand Omeprazole. 18 different companies have already filed for the generic of Omeprazole, 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 Omeprazole's generic
Alternative Brands for Omeprazole
There are several other brand drugs using the same active ingredient (Omeprazole) as 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 |
| ||||
| 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, Omeprazole's active ingredient. Check the complete list of approved generic manufacturers for Omeprazole
About Omeprazole
Omeprazole is a drug owned by Dexcel Pharma Technologies Ltd. Omeprazole uses Omeprazole as an active ingredient. Omeprazole was launched by Dexcel in 2017.
Approval Date:
Omeprazole was approved by FDA for market use on 05 July, 2017.
Active Ingredient:
Omeprazole uses Omeprazole as the active ingredient. Check out other Drugs and Companies using Omeprazole ingredient
Dosage:
Omeprazole is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET, DELAYED RELEASE | Over the counter | ORAL |