Omeprazole - Generic Drug Details

What are the generic drug sources for omeprazole and what is the scope of patent protection?

Omeprazole is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Pharmobedient, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Astrazeneca, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Aurobindo Pharma Ltd, L Perrigo Co, Spil, Covis, Marksans Pharma, P And L, Perrigo R And D, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Sciegen Pharms Inc, Strides Pharma Intl, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in fifty-five NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirteen patent family members in eight countries.

There are one hundred and thirty-one drug master file entries for omeprazole. Ninety-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for omeprazole

International Patents:	13
US Patents:	11
Tradenames:	8
Applicants:	39
NDAs:	55
Drug Master File Entries:	131
Finished Product Suppliers / Packagers:	93
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	487
Patent Applications:	6,975
Drug Prices:	Drug price trends for omeprazole
Drug Sales Revenues:	Drug sales revenues for omeprazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for omeprazole
What excipients (inactive ingredients) are in omeprazole?	omeprazole excipients list
DailyMed Link:	omeprazole at DailyMed

See drug prices for omeprazole

See drug sales revenues for omeprazole

Recent Clinical Trials for omeprazole

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rehman Medical Institute - RMI	PHASE4
Bristol-Myers Squibb	PHASE1
Genentech, Inc.	PHASE1

See all omeprazole clinical trials

Generic filers with tentative approvals for OMEPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		40MG	CAPSULE, DELAYED REL PELLETS;ORAL
		20MG	CAPSULE, DELAYED REL PELLETS;ORAL
		10MG	CAPSULE, DELAYED REL PELLETS;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for omeprazole

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for omeprazole

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for omeprazole

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for OMEPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMEPRAZOLE	Delayed-release Tablets	omeprazole	20 mg	022032	1	2015-06-03

US Patents and Regulatory Information for omeprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	091672-002	Oct 31, 2014	AB	RX	No	No
Zydus Pharms	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203290-001	May 25, 2018	AB	RX	No	No
Sandoz	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	075757-002	Jan 28, 2003	AB	RX	No	Yes

Expired US Patents for omeprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	5,599,794*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	4,853,230*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	5,599,794*PED

International Patents for omeprazole

Country	Patent Number	Title	Estimated Expiration
Germany	60038447
World Intellectual Property Organization (WIPO)	0078284
Australia	2017285390	Stable orally disintegrating pharmaceutical compositions

Supplementary Protection Certificates for omeprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Omeprazole

Last updated: July 27, 2025

Introduction

Omeprazole, a proton pump inhibitor (PPI), is one of the most widely prescribed medications globally for acid-related gastrointestinal disorders. Since its approval in the late 1980s, it has become a cornerstone in treating conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. The evolving landscape of healthcare, patent status, emerging competitors, and shifting regulatory policies significantly influence omeprazole’s market performance and future financial trajectory.

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Market Overview and Key Drivers

Global Market Size and Growth Trends

The global proton pump inhibitor market, including omeprazole, was valued at approximately USD 15 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of about 3-4% through 2030. This growth is driven by increasing prevalence of acid-related disorders, rising aging populations, and expanding healthcare access across emerging markets.

Prevalence of Acid-Related Diseases

The increasing incidence of GERD, peptic ulcers, and Zollinger-Ellison syndrome sustains demand. According to the Global Burden of Disease Study 2019, millions worldwide suffer from chronic acid reflux, bolstering prescription rates for omeprazole.

Advancements in Diagnostic and Treatment Protocols

Better diagnostic tools and increased awareness foster earlier intervention with PPIs, ensuring sustained demand.

Healthcare Policy and Reimbursement

National reimbursement policies influence prescribing practices. Countries with comprehensive coverage for GI medications, such as the US and Europe, favor continued high utilization of omeprazole.

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Market Dynamics Influencing Omeprazole

Patent and Market Exclusivity

Original brand formulations of omeprazole, such as Prilosec by AstraZeneca, faced patent expirations starting around 2001-2002. This triggered the proliferation of generic versions, significantly reducing prices and impacting revenue streams for branded producers.

Generic Competition and Price Erosion

Post-patent expiration, the entry of robust generics dramatically lowered omeprazole costs. For instance, in the US, the price of generic omeprazole dropped by over 80% within a few years post-patent loss, leading to increased volume sales but reduced margins for manufacturers.

Emerging Alternatives and Adjunct Therapies

Proton pump inhibitors face competition from newer drugs with improved safety profiles, such as vonoprazan (a potassium-competitive acid blocker), and from non-pharmacological management options. The advent of H2 receptor antagonists like ranitidine, although faced with safety concerns, also influences the competitive landscape.

Regulatory Dynamics

Regulatory authorities globally are scrutinizing long-term PPI use due to associations with adverse events—risk of chronic kidney disease, fractures, and infections. These concerns may lead to revised guidelines, impacting prescription patterns.

Supply Chain and Manufacturing Factors

Global supply disruptions, especially during events like the COVID-19 pandemic, impacted production and distribution channels, influencing availability and pricing dynamics.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Historically, omeprazole has maintained substantial revenues, especially during the early 2000s when patent protection was intact. As generics entered, revenues transitioned from high-margin sales of branded versions to high-volume, low-margin generic sales.

Current Market and Revenue Forecasts

• Emerging Markets: Rapid growth in regions such as Asia-Pacific supports volume expansion, even as prices decline. Increasing healthcare infrastructure and GI disorder prevalence reinforce this trend.
• Developed Markets: Maturation of the market leads to stabilizing revenues, with a shift toward value-added formulations and combination therapies.
• Pipeline and Formulation Innovations: Development of combination drugs, extended-release formulations, and novel delivery systems could create new revenue streams.

Pricing Strategies

Brand owners increasingly adopt value-based pricing and patient assistance programs to retain market share amid fierce generic competition.

Impact of Patent Expirations

While the original patents expired over two decades ago, some formulations or delivery devices may still be under patent protection or exclusivity, offering limited opportunities for branded sales enhancements.

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Future Outlook and Market Challenges

Regulatory and Safety Concerns

Emerging evidence linking long-term PPI use to adverse health outcomes can lead to prescriber caution, affecting sales volumes.

Innovations in Therapeutic Alternatives

Emerging therapies like vonoprazan and notable bidirectional shifts toward lifestyle modifications may erode omeprazole's market share.

Market Consolidation

In response to price pressures, manufacturers may pursue mergers or acquisitions, consolidating their portfolio of GI therapeutics to sustain revenues.

Digital and Digital Health Trends

Integration of digital health solutions, such as remote monitoring and personalized medicine, could influence medication adherence and prescribing behaviors, impacting overall sales.

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Key Takeaways

• Market Maturity and Competition: Once protected by patent exclusivity, omeprazole now faces stiff generic competition, leading to significant price erosion but sustained high-volume sales, especially in emerging markets.

• Growth Potential in Emerging Markets: Continuing healthcare infrastructure investments and rising GI disorder prevalence present opportunities for volume expansion.

• Regulatory and Safety Challenges: Growing concerns about long-term safety necessitate careful positioning and possible formulation adjustments to maintain prescriber confidence.

• Innovation and Pipeline Development: The future of omeprazole depends on innovation, including new formulation strategies and combination therapies, to create differentiation and renew revenue streams.

• Strategic Positioning: Manufacturers should focus on targeted marketing in high-growth regions, leverage superior formulation technologies, and adapt to evolving regulatory landscapes.

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FAQs

1. What is the current market status of omeprazole?
   Omeprazole remains one of the top-selling GI drugs globally, with a mature market primarily driven by generic versions following patent expiration. Its revenues now depend largely on volume sales and geographic distribution.

2. How has patent expiration affected omeprazole’s profitability?
   Patent expirations led to increased generic competition, sharply reducing prices and profit margins. While sales volumes increased, the revenue per unit decreased substantially.

3. What are the emerging threats to omeprazole’s market dominance?
   Newer acid-reducing agents like vonoprazan, safety concerns over long-term PPI use, and shifting treatment guidelines pose threats to its traditional markets.

4. What opportunities exist for companies seeking to innovate with omeprazole?
   Developing combination therapies, extended-release formulations, or repositioning for new indications could create new revenue streams and differentiate offerings.

5. How do healthcare policies influence the future of omeprazole?
   Policies favoring cost-effective treatments and safety monitoring could restrict long-term high-dose prescriptions, influencing demand and marketing strategies.

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References

1. Global Proton Pump Inhibitors Market, MarketsandMarkets, 2022.
2. Global Burden of Disease Study 2019, The Lancet, 2020.
3. AstraZeneca’s Prilosec patent history and market insights, 2001–2002.
4. FDA Drug Safety Communications, Proton Pump Inhibitors and Risks of Chronic Kidney Disease, 2018.
5. Future trends in gastrointestinal pharmacotherapy, Journal of Gastroenterology, 2021.