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 EUGIA PHARMA on August 10^th, 2016.

Summary for NEXIUM IV

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	162
Patent Applications:	100
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
Alexandria University	Phase 3
Nanfang Hospital of Southern Medical University	Phase 4
Liaocheng People's Hospital	Phase 1

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
Algeria	1785	Nouveaux composés.
Germany	69435221
Germany	69426254
Poland	307261
Spain	2326405
Spain	2326404
Taiwan	389761

Supplementary Protection Certificates for NEXIUM IV

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

Market Dynamics and Financial Trajectory for Nexium (Esomeprazole)

Introduction

Nexium, also known as esomeprazole, is a widely used proton pump inhibitor (PPI) manufactured by AstraZeneca. It is primarily used to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and other gastrointestinal disorders. Here, we will delve into the market dynamics and financial trajectory of Nexium, highlighting key trends, challenges, and future projections.

Market Size and Growth

The esomeprazole market, which includes Nexium, is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2029. This growth is driven by several factors, including the increasing prevalence of GERD and the rising acceptance of novel drug delivery systems[1].

Impact of COVID-19

The COVID-19 pandemic had an adverse impact on the esomeprazole market initially, as patients faced difficulties in accessing pharmacies and there was a shortage of medicines due to increased demand. However, the market has since recovered, driven by increased product sales, new product launches, and strategic developments[1].

Regional Market Performance

North America

North America holds the largest share in the esomeprazole market, primarily due to the growing geriatric population and the surge in patients with GERD. The United States is a significant contributor to this regional growth, driven by the adoption of novel drug delivery systems and the increasing prevalence of gastrointestinal diseases[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market for esomeprazole, driven by increasing healthcare expenditure and a rising awareness of gastrointestinal disorders[1].

Key Players and Market Competition

Major players in the esomeprazole market include Teva Pharmaceutical Industries Ltd., Amneal Pharmaceuticals LLC, Viatris Inc., DAIICHI SANKYO COMPANY, LIMITED, and Sun Pharmaceutical Industries Ltd. These companies are engaged in strategic developments, such as new product launches and partnerships, to maintain their market share[1].

Financial Performance of Nexium

Revenue Trends

In 2021, AstraZeneca's Nexium generated revenues of USD 1.33 billion, with a significant share in emerging markets. However, the global sales of Nexium have seen a historical decline with a CAGR of -25% between 2020 and 2023, primarily due to generic competition[1][4].

Recent Financial Updates

AstraZeneca's financial reports indicate that while Nexium faces generic competition, the company's overall revenue has been robust. For instance, in the first half of 2024, AstraZeneca's total revenue increased by 18%, driven by growth in other therapy areas such as oncology, cardiovascular, renal, and metabolism (CVRM), and respiratory and immunology (R&I)[5].

Mechanism of Action and Formulations

Esomeprazole, the active ingredient in Nexium, is a sulfinyl benzimidazole derivative that acts as an anti-ulcer agent. It is available in various formulations, including granules, hard gelatin capsules with coated pellets, and delayed-release tablets for oral administration[4].

Market Drivers

Increasing Prevalence of GERD

The increasing prevalence of GERD is a significant driver for the esomeprazole market. GERD is one of the most common gastrointestinal disorders, affecting approximately 20% of adults in Western cultures[1].

Novel Drug Delivery Systems

The acceptance of novel drug delivery systems is another key factor contributing to market growth. These systems enhance patient compliance and efficacy, making esomeprazole more appealing to both patients and healthcare providers[1].

Market Challenges

Generic Competition

One of the major challenges facing Nexium is the increasing generic competition. The entry of generic versions of esomeprazole has led to a decline in Nexium's sales, particularly in markets where generics are widely accepted[4].

Regulatory Approvals

While regulatory approvals for new formulations and indications can boost market growth, they also introduce competition. For example, Indchemie Health received FDA approval to manufacture and market esomeprazole magnesium capsules, adding to the competitive landscape[1].

Future Projections

Despite the challenges, the esomeprazole market is expected to continue growing. The increasing geriatric population and the rising prevalence of gastrointestinal diseases are anticipated to drive demand for esomeprazole. Additionally, strategic developments and new product launches by key players will contribute to market growth[1].

Key Takeaways

• The esomeprazole market is projected to grow at a CAGR of 5.2% from 2024 to 2029.
• North America holds the largest market share, while the Asia Pacific region is the fastest-growing.
• The increasing prevalence of GERD and the acceptance of novel drug delivery systems are key market drivers.
• Generic competition is a significant challenge facing Nexium.
• AstraZeneca's overall revenue remains robust despite declines in Nexium sales.

FAQs

What is the current market size of the esomeprazole market?

The esomeprazole market is projected to register a CAGR of 5.20% during the forecast period (2024-2029), but the exact current market size is not specified in the latest reports.

Who are the major players in the esomeprazole market?

Major players include Teva Pharmaceutical Industries Ltd., Amneal Pharmaceuticals LLC, Viatris Inc., DAIICHI SANKYO COMPANY, LIMITED, and Sun Pharmaceutical Industries Ltd.[1].

Which region has the largest share in the esomeprazole market?

North America accounts for the largest market share in the esomeprazole market[1].

What is the impact of COVID-19 on the esomeprazole market?

COVID-19 initially adversely impacted the market due to access issues and medicine shortages, but the market has since recovered driven by increased product sales and strategic developments[1].

What are the key drivers for the esomeprazole market?

Key drivers include the increasing prevalence of GERD and the rising acceptance of novel drug delivery systems[1].

Sources

1. Mordor Intelligence: Esomeprazole Market - Size, Share & Brands.
2. AstraZeneca: Full year and Q4 2022 results.
3. AstraZeneca: 9M and Q3 2023 results.
4. GlobalData: The Global Drug sales of Nexium.
5. AstraZeneca: H1 and Q2 2024 results.