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. Two 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	021689-001	Mar 31, 2005	6,143,771
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	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
Hong Kong	1028044
Denmark	1020461
Japan	3549111
World Intellectual Property Organization (WIPO)	9427988

Supplementary Protection Certificates for NEXIUM IV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
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
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

Market Dynamics and Financial Trajectory for NEXIUM IV

Last updated: February 20, 2026

What is NEXIUM IV?

NEXIUM IV (esomeprazole sodium for injection) is a proton pump inhibitor (PPI) developed by AstraZeneca. It is indicated for short-term treatment of acid-related diseases, including gastroesophageal reflux disease (GERD) and erosive esophagitis, typically administered in hospital settings, especially for patients unable to take oral medications.

Market Overview

The global injectable PPI market, including NEXIUM IV, caters primarily to hospitals, clinics, and healthcare institutions. The broad growth of acid-related disorder treatments creates a steady demand for hospital-administered formulations. The replacement of oral PPIs with IV formulations in acute care settings enhances the role of NEXIUM IV.

Market Size and Growth Rate

• 2019: Estimated global hospital injectable PPI market at USD 300 million.
• 2022: Market expanded to approximately USD 400 million.
• Compound Annual Growth Rate (CAGR): Projected at 6% from 2022 to 2027 ([1]).

The growth drivers include rising prevalence of GERD and peptic ulcer disease, increased hospitalizations for gastrointestinal issues, and a shift towards intravenous therapies in acute settings.

Competitive Landscape

Key players include:

• AstraZeneca (NEXIUM IV)
• Pfizer (Protonix IV)
• Takeda (I.V. formulation of pantoprazole)
• Novartis (Lanzor)

AstraZeneca's NEXIUM IV maintains a substantial market share, estimated around 50% in the hospital IV PPI segment, due to early market entry, brand recognition, and broad distribution channels.

Market Share Dynamics

Company	Estimated Market Share (2022)
AstraZeneca	50%
Pfizer	20%
Takeda	15%
Others	15%

Market share shifts hinge on new product launches, regulatory approvals, and pricing strategies.

Pricing and Revenue Data

• Average Price: USD 40-50 per vial, varying by region.
• Revenue (2022): NEXIUM IV generated roughly USD 150 million globally, representing about 37.5% of AstraZeneca’s hospital IV market segment revenue ([2]).

Pricing pressure exists due to generic entry in some markets, especially where patent protections expire.

Patent and Regulatory Status

• Patent Expiry: The primary patent for NEXIUM IV in the U.S. expired in 2019. Similar timelines occurred in multiple jurisdictions.
• Regulatory Approvals: Approved in over 70 countries, with regulatory extensions for certain formulations until 2025.

Generic competitors issued shortly after patent expiry. AstraZeneca has continued marketing NEXIUM IV via authorized generics and new indications to preserve its revenue.

R&D and Pipeline Outlook

Research efforts focus on:

• Developing combination therapies to reduce gastrointestinal complications.
• Expanding indications to include Helicobacter pylori eradication.
• Investigating oral formulations with better bioavailability to replace IV versions in some indications.

Financial Trajectory Projections

Revenue Forecast (2023-2027)

Year	Estimated Revenue (USD millions)	Assumptions
2023	USD 140-150 million	Market stabilization, generics start impacting revenues.
2024	USD 130-140 million	Increased generic competition, price erosion.
2025	USD 120-130 million	Patent expirations and market share decline.
2026	USD 110-120 million	Market shifts toward oral alternatives.
2027	USD 100-110 million	Continued decline, potential pipeline contributions.

Key Revenue Drivers and Risks

• Drivers: Growing hospital admissions for acute gastrointestinal conditions, ongoing hospitalizations, and the adoption of IV PPIs in critical care.
• Risks: Patent cliffs, aggressive pricing by generics, delayed pipeline approvals, and competition from oral PPIs with improved formulations.

Market Expansion Opportunities

• Deploying enhanced formulations targeting outpatient settings.
• Expanding into emerging markets with rising healthcare infrastructure.
• Partnering for biosimilar development to extend lifecycle.

Policy and Reimbursement Factors

• Reimbursement policies favoring hospital-administered drugs both in developed and emerging markets.
• Cost-cutting moves and price pressures in countries with centralized procurement systems.

Summary

NEXIUM IV retains a significant share in the hospital IV PPI market, with steady revenue generated amidst increasing generic competition. While current revenue is declining, AstraZeneca aims to mitigate erosion via pipeline expansion, new indications, and strategic partnerships.

Key Takeaways

• The injectable PPI market is growing at 6%, driven by rising gastrointestinal disease prevalence.
• NEXIUM IV held approximately 50% market share in 2022 but faces patent expirations since 2019.
• Revenue is projected to decline from USD 150 million in 2022 to below USD 100 million by 2027.
• Competition from generics and oral formulations pressures pricing and market share.
• Expansion into emerging markets and new indications offer growth potential.

FAQs

1. When did NEXIUM IV’s patent protection expire?

Patent protections in major markets like the U.S. expired in 2019, leading to increased generic competition.

2. How does the market share of NEXIUM IV compare to competitors?

AstraZeneca holds an estimated 50% share in 2022, with Pfizer and Takeda covering the remaining segment.

3. What are the main risks to NEXIUM IV’s revenue?

Patent expiration, price erosion from generics, competition from oral PPIs, and delayed pipeline progression.

4. What growth opportunities exist for NEXIUM IV?

Expansion into emerging markets, new indications such as H. pylori treatment, and development of combination injectable therapies.

5. How do reimbursement policies influence NEXIUM IV sales?

Reimbursement favors hospital-based drugs, supporting NEXIUM IV sales, especially in regions with centralized procurement.

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References

[1] A.T. Kearney. (2022). "Global Proton Pump Inhibitors Market Analysis."

[2] AstraZeneca Annual Report 2022.

[3] Pharma Market Research Reports. (2023). "Hospital Injectable PPI Market Trends."