PRILOSEC Drug Patent Profile

When do Prilosec patents expire, and what generic alternatives are available?

Prilosec is a drug marketed by Astrazeneca and Covis and is included in three NDAs.

The generic ingredient in PRILOSEC is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prilosec

A generic version of PRILOSEC was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5^th, 2009.

Summary for PRILOSEC

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	51
Patent Applications:	4,076
Drug Prices:	Drug price information for PRILOSEC
Drug Sales Revenues:	Drug sales revenues for PRILOSEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRILOSEC
What excipients (inactive ingredients) are in PRILOSEC?	PRILOSEC excipients list
DailyMed Link:	PRILOSEC at DailyMed

See drug prices for PRILOSEC

See drug sales revenues for PRILOSEC

Recent Clinical Trials for PRILOSEC

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

Sponsor	Phase
Pfizer	Phase 1
Carlos Roberto Simons-Linares	Phase 4
Emory University	Phase 4

See all PRILOSEC clinical trials

Pharmacology for PRILOSEC

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

US Patents and Regulatory Information for PRILOSEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995		DISCN	Yes	No
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-001	Mar 20, 2008		RX	Yes	No
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989		DISCN	Yes	No
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998		DISCN	Yes	No
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003		OTC	Yes	Yes
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-002	Mar 20, 2008		RX	Yes	Yes

Expired US Patents for PRILOSEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	5,629,305*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	6,191,148*PED
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-001	Mar 20, 2008	5,900,424
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	4,636,499*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	6,150,380*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	6,150,380*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	5,629,305*PED

International Patents for PRILOSEC

See the table below for patents covering PRILOSEC around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	198427	2-(DI- OR TRI-METHYLPYRID-2-YLMETHYLTHIO) BENZIMIDAZOLES
China	1041798
German Democratic Republic	142882	VERFAHREN ZUR HERSTELLUNG VON PYRIDYLMETHYLSULFINYLBENZIMIDAZOLEN
Argentina	016700	OMEPRAZOL FORMA A CRISTALINA. PROCESO PARA SU PREPARACION, FORMULACIONES FARMACEUTICAS QUE LO CONTIENEN, Y USO DEL MISMO
Portugal	1124539
Latvia	10357	NEW PHARMACEUTICAL PREPARATION, A METHOD FOR THE MANUFACTURE OF THE SAME AND USE OF THEM FOR TREATMENT OF GASTROINTESTINAL DISEASES
Spain	2285857

Supplementary Protection Certificates for PRILOSEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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
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
0005129	SPC/GB99/015	United Kingdom		SPC/GB99/015, EXPIRES: 20021115

Market Dynamics and Financial Trajectory for Prilosec (Omeprazole)

Last updated: July 28, 2025

Introduction

Prilosec, the brand name for omeprazole, is a proton pump inhibitor (PPI) primarily used for managing gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Since its introduction by AstraZeneca in 1988, Prilosec has become a cornerstone in the treatment of acid-related disorders. This analysis explores the evolving market dynamics and financial trajectory of Prilosec, considering competitive landscape shifts, patent status, regulatory influences, and regional market opportunities.

Market Overview and Historical Performance

Initially launched as the first PPI on the global market, Prilosec revolutionized acid suppression therapy. Its success was driven by high efficacy, favorable safety profile, and widespread clinical adoption. The drug quickly captured significant market share, with sales peaking in the early 2000s, largely driven by its status as a pioneer in the PPI class [1].

In 2001, AstraZeneca introduced Nexium (esomeprazole), a more potent successor to Prilosec, which subtly eroded Prilosec’s market share through patent extensions and targeted marketing. As generics entered the market post-patent expiry in 2009, the drug’s revenue significantly declined, with sales largely shifting to the low-cost generics market. Nonetheless, Prilosec maintained a steady presence, especially in generic formulations.

Competitive Landscape and Market Dynamics

Patent Expiry and Generic Competition

The expiration of Prilosec’s U.S. patent in 2009 marked a pivotal turning point, leading to an influx of generic omeprazole products. Generic versions typically command around 50-70% of the total market share in the PPI segment, drastically reducing the brand’s revenue. According to IQVIA data, generic omeprazole sales in the U.S. increased exponentially post-patent expiry, with combined sales of generics reaching approximately $1.2 billion annually [2].

Therapeutic Substitutes and Market Competition

The PPI market is highly competitive, with drugs like Esomeprazole (Nexium), Pantoprazole (Protonix), Lansoprazole (Prevacid), and Dexlansoprazole (Dexilant) vying for market share. While these drugs are pharmacologically similar, variations in efficacy, safety profiles, and patent protections influence prescribing patterns.

Shift to Over-the-Counter and Pharmacy-Level Access

Prilosec's transition to over-the-counter (OTC) availability in the United States around 2003 has expanded its reach among consumers, increasing sales through the OTC channel. However, this shift also diminishes prescription revenues while expanding retail sales, making it a dual-channel product. OTC sales contributed significantly to Prilosec’s revenue during the early 2010s, peaking at approximately $400 million annually [3].

Regulatory and Patent Strategies

AstraZeneca's strategic patent extensions via formulation patents and exclusive rights delayed generic erosion during the early 2000s. These regulatory tactics temporarily preserved market exclusivity and revenue. However, once expired, competition intensified, and price competition became the norm.

Regional Market Dynamics

United States

The US remains a dominant market segment due to high prevalence rates of GERD and other acid-related conditions. The availability of OTC Prilosec facilitated widespread usage, but in recent years, the market has become saturated with generics and OTC options. The introduction of lower-dose OTC formulations has broadened consumer access, but with diminishing long-term prescription revenues for AstraZeneca/its successors.

Europe

European markets exhibit similar dynamics, with Prilosec facing competition from both generic omeprazole brands and newer PPIs. Regulatory differences and reimbursement policies influence penetration rates.

Emerging Markets

In regions like Asia-Pacific and Latin America, the demand for affordable PPIs sustains Prilosec's market presence. Local manufacturers often produce generic versions, leading to price competitiveness and increased accessibility.

Financial Trajectory and Revenue Trends

Post-patent expiry, Prilosec’s revenue experienced a rapid decline. AstraZeneca’s 2009 global sales figures for Prilosec (including OTC and prescription) declined from a peak of approximately $1.3 billion in 2001 to under $300 million by 2012, largely driven by generic competition and OTC sales [4].

Subsequently, AstraZeneca faced generic erosion, and by 2014, Prilosec’s sales further dwindled, with the brand essentially phased out in many markets. In 2014, AstraZeneca transitioned Prilosec's rights to a new owner, and its role shifted primarily to OTC sales. Today, the drug's revenue is minimal in the context of the company's overall portfolio, with most sales in the generics sector managed by multiple manufacturers.

Impact of Patent and Regulatory Developments

Patent litigations and strategic patent filings initially extended Prilosec's market exclusivity. However, in 2009, the expiry of the primary patent led to a swift decline in sales. The introduction of OTC formulations in both prescription and retail settings expanded access but further fragmented revenue streams.

Regulatory frameworks in different jurisdictions continue to influence the drug's availability and market share. For example, reclassification as OTC in multiple countries enabled broader consumer access but limited potential for prescribed drug sales, impacting revenue streams.

Future Perspectives and Market Outlook

Generic Dominance and Price Competition

The market for Prilosec largely resides within the generic segment. Price competition among generics is intense, leading to declining margins. According to industry analysts, the average wholesale price for generic omeprazole in the U.S. has decreased by almost 80% since 2009 [2].

Emerging Biosimilar and Novel Alternatives

While Prilosec's market is mature, innovation in acid suppression, including novel drug classes and biosimilars, could influence future demand. The advent of potassium-competitive acid blockers (P-CABs), such as vonoprazan, presents potential competitors, possibly impacting Prilosec’s residual market share.

Regulatory Environment and Patent Strategies

Future market dynamics depend heavily on patent protections, regulatory approvals, and marketing strategies. Companies may seek new formulations or combination therapies that can extend market life or create niche uses.

Conclusion

Prilosec’s market dynamics reveal a classic lifecycle pattern of pharmaceutical evolution: initial innovation leading to blockbuster success, subsequent patent expiry, intense generic competition, and eventual market maturity. While it remains accessible globally, especially through OTC channels, its revenue trajectory has declined sharply over the past decade, reflecting broader industry trends in patent management, generic proliferation, and competitive innovation.

Key Takeaways

• Expiration of patent in 2009 fundamentally shifted Prilosec’s market share from branded to generics, with a corresponding revenue decline.
• Generic competition dominates the landscape, exerting downward pressure on prices and margins.
• The OTC transition expanded consumer access but reduced prescription revenue, shifting sales to retail channels.
• Regional differences influence market size, with the US and Europe serving as mature markets, while emerging economies offer growth potential.
• Future prospects hinge on either novel formulation strategies, regulatory protections, or disruptive innovations like biosimilars and P-CABs.

FAQs

1. How has Prilosec’s market share changed since its patent expiry?
Prilosec’s market share drastically declined post-patent expiry due to the influx of cheaper generic versions. While it retained residual sales through OTC channels and specific formulations, its dominance as a prescription drug diminished significantly, with generics accounting for over 70% of the PPI market in regions like the US.

2. What are the main factors influencing Prilosec’s revenue today?
The primary factors include the prevalence of generic competition, shifts to OTC sales, pricing pressures, regional regulatory landscapes, and emerging alternative therapies such as P-CABs. These elements collectively diminish the brand’s revenue potential.

3. Could Prilosec regain market dominance?
It is unlikely given the competitive environment and existence of newer, more potent PPIs and alternative classes. Nonetheless, niche indications or formulations could sustain residual relevance, particularly in markets with limited healthcare infrastructure.

4. How do regional regulatory policies impact Prilosec’s sales?
Regulatory policies determine whether the drug is available OTC or as prescription-only, influencing access, pricing, and marketing strategies. Reclassification as OTC tends to increase volume but lowers prescription revenue, differing across jurisdictions.

5. What is the outlook for the long-term viability of Prilosec?
Its long-term viability as a leading treatment option is limited. The focus now shifts to legacy sales, niche uses, and potential competition from biosimilars or proprietary drugs offering improved efficacy or safety profiles.

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Sources
[1] AstraZeneca Annual Reports, 2000-2010.
[2] IQVIA Pharmacy Data, 2022.
[3] Nielsen OTC Sales Data, 2015-2021.
[4] Company Financial Statements, 2001-2014.