Esomeprazole magnesium - Generic Drug Details

What are the generic sources for esomeprazole magnesium and what is the scope of patent protection?

Esomeprazole magnesium is the generic ingredient in five branded drugs marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cipla, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Astrazeneca, Aurobindo Pharma, Guardian Drug, Marksans Pharma, Perrigo R And D, Pharmobedient, Astrazeneca Lp, P And L, Dexcel, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Sciegen Pharms Inc, and Horizon, and is included in sixty-one NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium has four patent family members in three countries.

There are fifty-nine drug master file entries for esomeprazole magnesium. One hundred and thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for esomeprazole magnesium

International Patents:	4
US Patents:	2
Tradenames:	5
Applicants:	36
NDAs:	61
Drug Master File Entries:	59
Finished Product Suppliers / Packagers:	113
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	2,845
Drug Prices:	Drug price trends for esomeprazole magnesium
Drug Sales Revenues:	Drug sales revenues for esomeprazole magnesium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for esomeprazole magnesium
What excipients (inactive ingredients) are in esomeprazole magnesium?	esomeprazole magnesium excipients list
DailyMed Link:	esomeprazole magnesium at DailyMed

See drug prices for esomeprazole magnesium

See drug sales revenues for esomeprazole magnesium

Recent Clinical Trials for esomeprazole magnesium

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

Sponsor	Phase
Livzon Pharmaceutical Group Inc.	PHASE3
Bio-innova Co., Ltd	PHASE1
Liaocheng People's Hospital	PHASE1

See all esomeprazole magnesium clinical trials

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant	Application No.	Strength	Dosage Form
		EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL
		EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE;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 esomeprazole magnesium

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

Anatomical Therapeutic Chemical (ATC) Classes for esomeprazole magnesium

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

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 ESOMEPRAZOLE MAGNESIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXIUM	Delayed-release for Oral Suspension	esomeprazole magnesium	2.5 mg and 5 mg	021957	1	2018-09-24
NEXIUM	Delayed-release for Oral Suspension	esomeprazole magnesium	10 mg	022101	1	2018-07-06
NEXIUM 24HR	Delayed-release Capsules	esomeprazole magnesium	20 mg	204655		2014-04-24
NEXIUM	Delayed-release for Oral Suspension	esomeprazole magnesium	20 mg and 40 mg	021957	1	2013-08-01
NEXIUM	Delayed-release Capsules	esomeprazole magnesium	20 mg and 40 mg	021153	1	2005-08-05

US Patents and Regulatory Information for esomeprazole magnesium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	217427-002	Oct 18, 2023	AB	RX	No	No
Aurobindo Pharma Ltd	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	214473-001	Jul 12, 2023		OTC	No	No
Macleods Pharms Ltd	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	208511-001	Oct 23, 2024		DISCN	No	No
Cipla	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	217714-001	Jan 7, 2025	AB	RX	No	No
Hetero Labs Ltd Iii	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	211977-002	Jun 2, 2020	AB	RX	No	No
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011	AB	RX	Yes	No

Expired US Patents for esomeprazole magnesium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	6,875,872*PED
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	6,369,085*PED
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011	6,369,085*PED
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-001	Oct 20, 2006	4,738,974*PED
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	5,093,342
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006	6,428,810*PED

International Patents for esomeprazole magnesium

Country	Patent Number	Title	Estimated Expiration
Australia	2017285390	Stable orally disintegrating pharmaceutical compositions
Australia	2017285390
World Intellectual Property Organization (WIPO)	2017216789
European Patent Office	3932396	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)
European Patent Office	3932396
European Patent Office	3471708	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for esomeprazole magnesium

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
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
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

Market Dynamics and Financial Trajectory for Esomeprazole Magnesium

Last updated: July 27, 2025

Introduction

Esomeprazole magnesium, a proton pump inhibitor (PPI), is widely used in the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its efficacy in reducing gastric acid secretion has cemented its position as a cornerstone drug within the gastrointestinal therapeutic landscape. This article examines the market dynamics influencing esomeprazole magnesium, alongside an analysis of its financial trajectory, driven by patent status, competitive landscape, regulatory environment, and emerging therapeutic trends.

Market Overview

Esomeprazole magnesium generates significant revenue globally, representing a substantial share of the PPI market. Its immediate predecessor, omeprazole, laid the groundwork for PPIs’ dominance, but esomeprazole’s enhanced pharmacokinetics has propelled its adoption, especially post-patent expiration of original formulations. The global PPI market was valued at approximately USD 13 billion in 2022, with projections suggesting a compound annual growth rate (CAGR) of ~4-6% over the next five years, driven by rising gastrointestinal disorder prevalence and aging populations [1].

The key players include AstraZeneca (originator), Teva Pharmaceuticals, Dr. Reddy's Laboratories, and emerging biosimilar entrants. Generics have significantly impacted pricing dynamics, resulting in increased accessibility but also intensified competition.

Market Dynamics

Patent Expiry and Generic Competition

A primary factor shaping the esomeprazole magnesium market is patent expiry. AstraZeneca's patent for Nexium (the brand name for esomeprazole) expired in many territories around 2015-2016, prompting a surge in generic versions. Generics now account for over 70% of prescriptions in several markets, drastically reducing per-unit revenue for innovators [2].

Pricing and Reimbursement Policies

Increased generic availability has led to a decline in drug prices, pressuring profit margins. As governments and insurers aim to contain healthcare costs, reimbursement policies favor low-cost generics, accentuating price competition.

Regulatory Environment

Regulatory agencies such as the FDA and EMA continuously update safety profiles and approve biosimilar or alternative formulations. The approval of over-the-counter (OTC) formulations in some markets has expanded accessibility and sales volume but has also shifted the revenue from prescription to OTC segments, often at lower margins.

Emerging Therapeutics and Market Competition

Despite dominance by PPIs, the advent of novel therapeutic agents such as potassium-competitive acid blockers (e.g., vonoprazan) presents potential competition. These drugs offer faster onset and longer duration, potentially capturing market share from traditional PPIs [3].

Market Segmentation and Regional Dynamics

• North America: Largest market share, driven by high GERD prevalence, insurance coverage, and widespread OTC availability.
• Europe: Stable growth, influenced by aging population and healthcare policies promoting generic substitution.
• Asia-Pacific: Rapid growth, fueled by increasing urbanization, dietary shifts, and expanding healthcare infrastructure.

Financial Trajectory

Revenue Trends

Post-patent expiration, revenue from esomeprazole magnesium has seen a decline in branded sales but increased volume share of generics offsets some losses. AstraZeneca’s branded Nexium sales peaked near USD 6 billion in 2008, but now constitute a smaller share, with global sales diminishing to approximately USD 600 million in 2022 [4].

Profitability and Cost Structures

Patent expirations and market competition have compressed profit margins. Companies focusing on biosimilars or improving formulations aim to sustain margins. R&D investments for next-generation acid reducers or combination therapies remain vital for future growth.

Strategic Diversification

Pharmaceutical firms are diversifying investments into complementary GI therapies, diagnostics, and personalized medicine to offset declining PPI revenues. Strategic collaborations, licensing deals, and acquisitions are prevalent to expand product pipelines and penetrate emerging markets.

Emerging Revenue Streams

OTC formulations and long-term management therapies promise incremental revenue. Licensing of new formulations or delivery systems, such as delayed-release tablets, also contribute positively to the financial outlook.

Challenges and Opportunities

Challenges

• Price erosion due to generics.
• Competitive threats from novel agents.
• Regulatory hurdles for biosimilars.
• Potential side effects and safety concerns impacting market acceptance.

Opportunities

• Developing next-generation PPIs with improved safety profiles.
• Expanding into emerging markets.
• Developing combination therapies that enhance convenience or efficacy.
• Investing in biosimilar development to recoup losses from original molecules.

Conclusion

The market dynamics surrounding esomeprazole magnesium are shaped by patent expirations, evolving regulatory and reimbursement landscapes, and the rise of competitive novel therapies. While revenue from branded formulations has declined, strategic initiatives focusing on generics, biosimilars, and OTC segments are critical to sustaining profitability. The overall financial trajectory suggests steady growth in global gastrointestinal markets, with firms that adapt to competitive pressures and invest in innovation poised for long-term success.

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Key Takeaways

• Patent expiration has transformed esomeprazole magnesium from a premium branded drug to a competitive generic market, with significant implications for revenue.
• Pricing pressures from generics and evolving reimbursement policies challenge profitability, prompting strategic diversification.
• Emerging therapies, such as potassium-competitive acid blockers, threaten traditional PPI dominance and may redefine market shares.
• Regional disparities influence market dynamics, with Asia-Pacific emerging as a high-growth zone.
• Innovation in formulations, combination therapies, and biosimilars offers opportunities to offset declining traditional revenues.

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FAQs

1. How has patent expiration impacted the revenue of esomeprazole magnesium?
Patent expiration led to the proliferation of generic versions, dramatically reducing per-unit prices and branded sales, although increased volume of generic prescriptions partially offset revenue declines for original developers.

2. What are the main competitive threats to esomeprazole magnesium in the current market?
Emerging drugs like potassium-competitive acid blockers, biosimilars, and enhanced OTC formulations pose threats by offering alternatives with improved efficacy, safety, or convenience.

3. Which regions present the most growth potential for esomeprazole magnesium and its generics?
The Asia-Pacific region offers significant growth due to demographic shifts, rising gastrointestinal disease prevalence, and expanding healthcare infrastructure. North America and Europe remain key markets with high consumption volumes.

4. How do regulatory changes influence the market dynamics of esomeprazole magnesium?
Regulatory agencies approving OTC formulations or biosimilars influence accessibility, pricing, and competitive landscapes, impacting revenues and marketing strategies.

5. What strategic moves can pharmaceutical companies adopt to sustain profitability?
Investing in next-generation formulations, expanding into emerging markets, developing combination therapies, and pursuing biosimilar opportunities are critical strategies to adapt amidst patent expiries and competition.

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References

[1] MarketWatch, "Proton Pump Inhibitors Market Size, Share & Industry Trends," 2022.
[2] IMS Health Data, "Impact of Patent Expiry on PPI Market," 2022.
[3] Clinical Pharmacology, "Comparison of PPIs and Potassium-Competitive Acid Blockers," 2021.
[4] AstraZeneca Annual Report, "Nexium Sales Overview," 2022.