NEXIUM IV Drug Patent Profile

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

Nexium Iv is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in NEXIUM IV 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 Iv

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

Summary for NEXIUM IV

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	165
Patent Applications:	7
Drug Prices:	Drug price information for NEXIUM IV
DailyMed Link:	NEXIUM IV at DailyMed

See drug prices for NEXIUM IV

Recent Clinical Trials for NEXIUM IV

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 IV clinical trials

Paragraph IV (Patent) Challenges for NEXIUM IV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXIUM IV	For Injection	esomeprazole sodium	20 mg/vial and 40 mg/vial	021689	1	2009-11-23

US Patents and Regulatory Information for NEXIUM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005		DISCN	Yes	No
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005		DISCN	Yes	No

Expired US Patents for NEXIUM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005	5,877,192*PED
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005	6,143,771
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005	6,143,771
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005	5,877,192*PED

International Patents for NEXIUM IV

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

Country	Patent Number	Title	Estimated Expiration
Canada	2337581
Yugoslavia	49065
Spain	2099047
Japan	2004043493	NEW COMPOUND
Greece	970300012

Supplementary Protection Certificates for NEXIUM IV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1020461	91870	Luxembourg
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
1020461	C300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214

Market Dynamics and Financial Trajectory for NEXIUM IV

Last updated: July 30, 2025

Introduction

NEXIUM IV (esomeprazole sodium for injection) represents a critical segment within the pharmaceutical landscape, targeting acid-related gastrointestinal disorders. As a proton pump inhibitor (PPI), NEXIUM IV is primarily employed in acute care and hospital settings for managing conditions such as gastric ulcers, erosive esophagitis, and stress-related mucosal damage. Its market performance, driven by evolving healthcare dynamics and regulatory landscapes, offers insight into its future financial trajectory.

Pharmaceutical Profile and Pharmacology

NEXIUM IV, a formulation of esomeprazole, the S-isomer of omeprazole, offers enhanced acid suppression with improved pharmacokinetic stability. Its intravenous delivery caters to patients unable to tolerate oral medications, establishing a niche in hospital and surgical environments [1].

The drug’s pharmacokinetics allows for rapid onset of action, making it valuable in critical care. Its safety profile, coupled with efficacy, underpins its widespread adoption across multiple regions.

Market Drivers and Growth Factors

Increasing Prevalence of Gastrointestinal Disorders

The global burden of gastroesophageal reflux disease (GERD) and peptic ulcer disease remains substantial. Reports indicate rising incidence rates propelled by lifestyle factors such as obesity, smoking, and dietary habits, which fuel demand for effective acid suppression therapies like NEXIUM IV [2].

Increasing Hospitalizations and Critical Care Procedures

Growing rates of surgeries, intensive care admissions, and stress ulcer prophylaxis contribute significantly to the demand for IV PPIs. Hospitals prioritize potent, rapid-acting solutions for acute conditions, positioning NEXIUM IV favorably in institutional formularies [3].

Pharmaceutical Innovation and Competitive Landscape

While generic versions of PPIs are widespread, NEXIUM IV's brand strength and formulary preferences sustain its market presence. Furthermore, innovations in drug delivery and improved formulations bolster its therapeutic profile.

Regulatory Approvals and Reimbursement Policies

Stringent regulatory pathways impact drug availability and market access. Favorable reimbursement policies in developed markets such as North America and Europe foster continued sales, whereas emerging markets promise expansion.

Competitive Environment and Market Share

The NEXIUM IV segment faces competition from other IV PPIs, including Protonix (pantoprazole) and IV formulations of omeprazole. Generic competition has exerted downward pressure on prices, impacting profit margins [4].

Despite this, NEXIUM IV maintains a strong brand presence owing to its demonstrated efficacy and established hospital protocols. Its position is reinforced by its early market entry and continuous endorsement through clinical guidelines.

Financial Trajectory and Revenue Trends

Historical Performance and Growth Patterns

Pfizer, the original manufacturer, reported steady U.S. sales for NEXIUM (including IV formulations) over the past decade, driven by hospital-based use [5]. However, patent expirations and generic entries have attenuated revenue growth, aligning with typical lifecycle curves of branded drugs.

Impact of Patent Expiry and Generic Competition

Patent loss in key markets has led to increased generic penetration, causing revenue erosion. For IV formulations, the attrition is somewhat mitigated by hospital formulary preferences and clinical inertia favoring branded products.

Emerging Market Expansion

Growth prospects in Asia, Latin America, and the Middle East hinge on expanding hospital infrastructure and increasing prevalence of gastrointestinal disorders. These regions offer incremental revenue, albeit tempered by pricing pressures and regulatory hurdles.

Pandemic Influence on Demand Dynamics

COVID-19 has indirectly affected demand patterns. Hospitals prioritize critical treatments, and disruptions to elective procedures may temporarily impact IV drug utilization [6]. Conversely, heightened hospital stay durations can sustain or elevate demand for IV PPIs.

Future Outlook and Strategic Considerations

Market Stabilization and Decline

Anticipated market saturation and intensified generic competition suggest a declining revenue trajectory in mature markets. However, continued hospital utilization and regulatory approvals for new indications could slow this decline.

Potential for Line Extensions and New Indications

Exploring new formulations or indications—such as H. pylori eradication adjuncts—may foster moderate growth. Additionally, reformulations improving administration or reducing costs could enhance competitiveness.

Emerging Trends: Biosimilars and Personalized Medicine

While biosimilars are less relevant for small molecules like NEXIUM IV, advancements in personalized therapy and integration into treatment protocols can influence market positioning.

Regulatory and Market Risks

• Pricing Pressures: Payers and healthcare systems increasingly scrutinize costs, pressuring prices for branded IV PPIs.
• Regulatory Barriers: Delays or restrictions in developing markets affect expansion prospects.
• Clinical Practice Shifts: Adoption of newer or alternative therapies, including endoscopic or surgical options, may diminish reliance on IV PPIs.

Conclusion

NEXIUM IV’s market dynamics are characterized by a mature but essential role within hospital therapeutics. Its financial trajectory is declining but remains relevant due to hospital protocols, clinical guidelines, and regional expansion opportunities. Strategic focus on emerging markets, optimizing formulations, and leveraging clinical evidence could prolong its commercial viability.

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Key Takeaways

• Market Position: NEXIUM IV maintains a vital niche in hospital-based acid suppression, supported by clinical efficacy and formulary preferences.

• Revenue Trends: Patent expiries and generic competition have constrained growth, with revenues plateauing or declining in mature markets.

• Growth Opportunities: Emerging markets and new therapeutic indications present avenues for incremental growth.

• Challenges: Pricing pressures, regulatory hurdles, and evolving clinical paradigms threaten long-term profitability.

• Strategic Focus: Innovation in formulations, regional expansion, and evidence-based positioning are critical to sustaining financial performance.

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FAQs

1. What are the primary drivers influencing the demand for NEXIUM IV?
Demand is primarily driven by the prevalence of gastrointestinal disorders, increasing hospitalizations requiring IV therapy, and clinical guidelines endorsing PPIs for stress ulcer prophylaxis.

2. How does patent expiry impact NEXIUM IV's market share?
Patent expirations facilitate generic competition, leading to price reductions and sales erosion, especially in mature markets. However, hospital formulary preferences for branded versions can mitigate this impact temporarily.

3. Are there emergent competitors threatening NEXIUM IV's market position?
Yes. Alternatives like Protonix (pantoprazole IV) and other PPI formulations compete for hospital utilization, with an increasing presence of generic options intensifying competition.

4. What regional markets hold the most promise for NEXIUM IV?
Emerging markets in Asia, Latin America, and the Middle East offer growth due to expanding healthcare infrastructure, rising disease prevalence, and governmental healthcare investments.

5. Can new indications or formulations rescue NEXIUM IV’s declining revenue trend?
Potentially. Developing novel formulations that improve administration or extending indications could sustain interest. Nonetheless, competition from newer therapies and cost considerations remain hurdles.

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Sources:

1. Pfizer. NEXIUM (esomeprazole) prescribing information. 2022.
2. Global Burden of Disease Study. Gastrointestinal disorders epidemiology. 2021.
3. MarketsandMarkets. Proton Pump Inhibitors Market. 2022.
4. EvaluatePharma. Industry report on PPI markets. 2022.
5. Pfizer Annual Reports. 2012–2022.
6. WHO. Impact of COVID-19 on hospital drug use. 2021.