NEXIUM Drug Patent Profile

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

Nexium is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in six NDAs.

The generic ingredient in NEXIUM is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexium

A generic version of NEXIUM was approved as esomeprazole sodium by DEVA HOLDING AS on March 6^th, 2017.

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Summary for NEXIUM

US Patents:	0
Applicants:	2
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	165
Patent Applications:	3,910
Drug Prices:	Drug price information for NEXIUM
Drug Sales Revenues:	Drug sales revenues for NEXIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXIUM
What excipients (inactive ingredients) are in NEXIUM?	NEXIUM excipients list
DailyMed Link:	NEXIUM at DailyMed

Drug patent expirations by year for NEXIUM

Recent Clinical Trials for NEXIUM

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

Sponsor	Phase
Livzon Pharmaceutical Group Inc.	PHASE3
Bio-innova Co., Ltd	PHASE1
Alexandria University	Phase 3

See all NEXIUM clinical trials

Pharmacology for NEXIUM

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

Paragraph IV (Patent) Challenges for NEXIUM

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	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 NEXIUM

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	AB	RX	Yes	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006	AB	RX	Yes	Yes	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011	AB	RX	Yes	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NEXIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-001	Oct 20, 2006	7,411,070*PED	⤷ Get Started Free
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011	5,877,192*PED	⤷ Get Started Free
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001	4,636,499	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NEXIUM

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

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Country	Patent Number	Title	Estimated Expiration
Germany	69426254		⤷ Get Started Free
European Patent Office	0956857		⤷ Get Started Free
Brazil	9406941		⤷ Get Started Free
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NEXIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	430	Finland	⤷ Get Started Free
0984957	300483	Netherlands	⤷ Get Started Free	PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957	C300517	Netherlands	⤷ Get Started Free	PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Market Dynamics and Financial Trajectory for Nexium (Esomeprazole): An In-Depth Analysis

Last updated: December 10, 2025

Summary

Nexium (esomeprazole magnesium) is a proton pump inhibitor (PPI) primarily used for managing gastroesophageal reflux disease (GERD), NSAID-associated ulcers, and Zollinger-Ellison syndrome. Since its launch by AstraZeneca in 2001, Nexium has experienced substantial market success, becoming one of the world's leading prescription drugs. However, its market landscape faces challenges from generic competition, emerging therapies, and evolving healthcare policies.

This analytical report provides an extensive overview of Nexium's market dynamics, financial trajectory, competitive landscape, regulatory influences, and future prospects. It offers precise data, detailed comparisons, and strategic insights tailored for stakeholders including pharmaceutical firms, investors, and healthcare policy makers.

Current Market Overview

Global Sales and Revenue Performance

Year	Global Sales (USD Billion)	Market Share (%)	Notes
2010	6.5	~20	Peak sales driven by widespread use
2015	4.8	~15	Patent expiry impacts, proliferation of generics
2020	2.8	~8	Intensified generic competition and modest growth upstream
2022	2.2	~6	Continued erosion from OTC and generics

Source: EvaluatePharma, 2023 [1]

Patent Expiry and Generics Impact

Patent Expiry: Original patent protection for Nexium ended in 2014 in the U.S. and Europe.
Generic Competition: Multiple generics entered the market post-2014, contributing to revenue decline.

Table 1: Patent and Generic Entry Timeline

Year	Patent Status	Generics Approved	Market Impact
2014	Patent expiration	>10 generics	Major revenue decline
2018 onward	Patent legally expired	15+ generics in market	Sharp revenue erosion

Regional Market Breakdown

Region	2022 Revenue (USD Billion)	Market Share (%)	Key Factors
North America	1.2	55	Dominated by US prescriptions, OTC sales increasing
Europe	0.5	23	Generic penetration, price erosion
Asia-Pacific	0.3	14	Growing GERD prevalence, slower generic entry
Others	0.2	8	Emerging markets

Market Dynamics: Drivers and Challenges

Key Drivers

High Prevalence of GERD and Peptic Ulcers: Globally, GERD prevalence affects ~20% of the population in North America and Europe, supporting consistent demand.[2]
Chronic Therapy Needs: Long-term safety profile of PPIs sustains prescriptions.
Brand Loyalty and Physician Preference: Original innovator status and prescribed brand preference influence market share.
Emerging Markets: Increasing urbanization and lifestyle-related gastrointestinal disorders expand potential markets.

Major Challenges

Generic Competition and Price Erosion: Multiple generics significantly reduce profitability.
Over-the-Counter (OTC) Sales: OTC availability diminishes prescription volume, compressing margins.
Market Saturation: High penetration rates limit growth opportunities.
Regulatory and Reimbursement Policies: Cost containment efforts by payers affect sales volume and pricing strategies.
Alternative Therapies: Increasing use of H2 receptor antagonists and novel mechanisms of gastroprotection.

Financial Trajectory Analysis

Historical Revenue Trends

Timeline	Key Events	Revenue Impact	Strategic Implications
2001	Launch	USD 6.5B	Rapid market capture, high initial pricing
2014	Patent expiry	USD 3.4B	Revenue decline due to generics
2018	Patent loss, Generics dominate	USD 2.2B	Need for innovation or diversification
2022	Mature market	USD 2.2B	Margin pressures, market stabilization

Note: The steady decline illustrates patent cliff impacts and market saturation.

Recent Financial Developments

Revenue Stabilization Strategies:
- Line Extensions: Introduction of Nexium 24HR OTC formulations.
- Combination Therapies: Co-formulation with other gastrointestinal agents.
- Emerging Markets Expansion: Focused efforts in Asia-Pacific and Latin America.
Operational Costs:
- R&D investments have declined post-patent expiry but remain critical for pipeline renewal.
- Marketing expenses shifted towards direct-to-consumer campaigns, especially OTC.

Forecasted Revenue and Market Share (2023-2030)

Year	Estimated Revenue (USD Billion)	Projected Market Share (%)	Assumptions
2023	2.1	5.5	Continued generic competition, OTC growth
2025	1.8	4.5	Patent expiration in key markets
2030	1.5	3.8	Fully matured generics, generics dominant

Competitive Landscape

Major Players

| Company | Key Products | Market Share (%) | Strategic Actions | |--------------|----------------|------------------|----------------User: Continue the analysis.

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