NEXIUM Drug Patent Profile

When do Nexium patents expire, and when can generic versions of Nexium launch?

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. Five 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 EUGIA PHARMA on August 10^th, 2016.

Summary for NEXIUM

US Patents:	0
Applicants:	2
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	162
Patent Applications:	4,188
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

See drug prices for NEXIUM

See drug sales revenues for NEXIUM

Recent Clinical Trials for NEXIUM

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 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

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
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006	AB	RX	Yes	Yes
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011		RX	Yes	No
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014		OTC	Yes	Yes
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001	AB	RX	Yes	Yes

Expired US Patents for NEXIUM

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
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011

International Patents for NEXIUM

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

Country	Patent Number	Title	Estimated Expiration
Germany	69003207
Norway	2011009
Malaysia	121192	NEW COMPOUNDS.
China	1025151
Norway	307378

Supplementary Protection Certificates for NEXIUM

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
0984957	CA 2012 00035	Denmark
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	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0984957	PA2011005,C0984957	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126

NEXIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nexium

Introduction

Nexium, also known as esomeprazole, is a widely used medication for treating various acid-related gastrointestinal disorders. This article delves into the market dynamics and financial trajectory of Nexium, highlighting key factors influencing its market performance.

Market Size and Growth

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

Impact of COVID-19

The COVID-19 pandemic had an initial adverse impact on the esomeprazole market, 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].

Major Players and Market Share

AstraZeneca's Nexium is a dominant player in the esomeprazole market. In 2021, Nexium generated revenues of USD 1.33 billion, with a significant share in emerging markets. AstraZeneca has also entered into agreements to out-license the rights to Nexium-authorized generics, further contributing to market growth[1].

Regional Market Performance

North America is expected to hold a significant share in the esomeprazole market, driven by the rising geriatric population and the increasing prevalence of GERD. The United States is a major contributor to this regional growth due to the adoption of novel drug delivery systems and the high prevalence of gastrointestinal diseases among Americans[1].

Product Forms and Preferences

The capsule segment of the esomeprazole market is expected to witness significant growth. Capsules are preferred due to their fast-acting nature, quicker breakdown compared to tablets, and the absence of unpleasant taste or odor. This segment is further boosted by product launches and research and development activities focused on esomeprazole capsules[1].

Mechanism of Action and Indications

Nexium, an anti-ulcer agent, is indicated for treating various acid-related diseases, including GERD, reflux esophagitis, hypersecretory conditions, gastric ulcers, and helicobacter pylori infections. Its mechanism of action involves inhibiting the proton pump in the stomach lining, reducing acid production[4].

Financial Performance of Key Players

AstraZeneca, the primary manufacturer of Nexium, reported total revenue of $45,811 million in 2023, with a 6% increase despite a decline in COVID-19 medicine sales. Excluding COVID-19 medicines, the total revenue increased by 15%. The company's core operating margin increased by two percentage points to 32%, reflecting the decline in sales of lower-margin COVID-19 medicines[5].

Global Sales of Nexium

Global sales of Nexium stood at USD 945 million in 2023. However, the sales have recorded a historical decline with a CAGR of 25% between 2020 and 2023. This decline is expected to continue, although at a slower rate, due to patent expirations and the rise of generic alternatives[4].

Competitive Landscape

The esomeprazole market is competitive, with several key players receiving approvals and market authorizations worldwide. For instance, Indchemie Health received FDA approval to manufacture and market esomeprazole magnesium capsules in 2021, increasing competition in the market[1].

Research and Development

Continuous research and development activities are crucial for the growth of the esomeprazole market. Clinical trials, such as the one sponsored by Onconic Therapeutics Inc. in 2022, evaluating the efficacy and safety of esomeprazole capsules compared to other treatments, contribute to market expansion[1].

Regulatory Environment

Regulatory approvals play a significant role in the market dynamics of Nexium. Companies like AstraZeneca and Indchemie Health have secured various approvals, which have helped in maintaining and expanding their market share[1].

Industry Payments and Prescriptions

Industry payments to physicians have been associated with increased prescriptions of brand-name medications, including Nexium. This highlights the influence of pharmaceutical marketing strategies on prescription patterns[3].

Market Projections

Despite the historical decline in global sales, Nexium is expected to maintain a significant market presence. The esomeprazole market's growth will be driven by the increasing prevalence of GERD, strategic developments, and the launch of new products. North America is expected to remain a dominant region, while the Asia Pacific region is anticipated to be the fastest-growing market[1].

Key Takeaways

• The esomeprazole market, including Nexium, is projected to grow at a CAGR of 5.2% from 2024 to 2029.
• North America is the largest market, driven by the rising geriatric population and increasing prevalence of GERD.
• The capsule segment is expected to witness significant growth due to its fast-acting nature and patient preference.
• AstraZeneca's financial performance indicates a strong market position despite declines in COVID-19 medicine sales.
• Continuous research and development, along with regulatory approvals, are crucial for market growth.

FAQs

What is the current market size and growth rate of the esomeprazole market?

The esomeprazole market is expected to register a CAGR of 5.2% over the forecast period from 2024 to 2029[1].

Which region is expected to dominate the esomeprazole market?

North America is expected to hold a significant share in the esomeprazole market, driven by the rising geriatric population and the increasing prevalence of GERD[1].

What are the key factors driving the growth of the esomeprazole market?

Key factors include the increasing prevalence of GERD, the rising acceptance of novel drug delivery systems, and strategic developments such as new product launches and market authorizations[1].

How has COVID-19 impacted 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 is the financial performance of AstraZeneca related to Nexium?

AstraZeneca reported total revenue of $45,811 million in 2023, with a 6% increase despite a decline in COVID-19 medicine sales. The core operating margin increased by two percentage points to 32%[5].

Sources

1. Esomeprazole Market - Size, Share & Brands - Mordor Intelligence
2. Consolidated Financial Results for FY2022 - Daiichi Sankyo
3. Industry Payments to Physicians and Prescriptions of Brand-Name ... - PubMed
4. The Global Drug sales of Nexium (2020 - 2026, USD Millions) - GlobalData
5. AstraZeneca Full year and Q4 2023 Financial Results - BioSpace