Omeprazole Generic: When Will Generic Omeprazole Be Available?

Omeprazole’s Road to a Generic

Omeprazole has had the market to itself since the FDA approved it in December 2007 (Dexcel Pharma Technologies Ltd). Its 3 listed patents run to December 2036. Generic companies have challenged its patents with the FDA since June 2015.

The first generic of Omeprazole is expected in December 2036.

Why that month: patent 10,835,488, on the product’s formulation, ends then.

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Omeprazole Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Omeprazole’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

The one that matters for a generic launch: patent 10,835,488, which ends in December 2036, the month the first generic is expected.

Source: FDA Orange Book, application 022032, 209400. Patent numbers open the patent on Google Patents.

Patent Challenges to Omeprazole

The first patent challenge to Omeprazole reached the FDA in June 2015, from one company on that first day. The FDA approved a first challenger’s generic in October 2018, and the list records no sale by a first challenger yet.

Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.

Who Is Lined Up to Make Generic Omeprazole

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Omeprazole Price: What Pharmacies Pay and What Generics Usually Do

What Medicare and Medicaid Spend on Omeprazole

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Omeprazole Strengths and Forms

Source: FDA Orange Book, Dexcel Pharma Technologies Ltd. Listed for sale today by Walgreen Company, Major Pharmaceuticals, Rite Aid Corporation, Kroger Company and 8 more (FDA NDC Directory).

Omeprazole NDC Codes and Packages

Each Omeprazole package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Source: the FDA NDC Directory, current listings only. Only packages sold under Omeprazole’s own FDA approval (NDA 22032, NDA 209400) are listed, never a generic. Some codes belong to companies that repackage Omeprazole: it is the same medicine in a different package.

Changes to This Projection

• October 2026First generic expected December 2036 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.