ESOMEPRAZOLE MAGNESIUM - Generic Drug Details

What are the generic drug sources for esomeprazole magnesium and what is the scope of patent protection?

Esomeprazole magnesium is the generic ingredient in five branded drugs marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Astrazeneca, Anda Repository, Aurobindo Pharma, Marksans Pharma, Norvium Bioscience, Perrigo R And D, Astrazeneca Lp, Cipla, P And L, Dexcel, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Sciegen Pharms Inc, and Horizon, and is included in fifty-six NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium has four patent family members in three countries.

There are fifty-nine drug master file entries for esomeprazole magnesium. One hundred and ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ESOMEPRAZOLE MAGNESIUM

International Patents:	4
US Patents:	2
Tradenames:	5
Applicants:	37
NDAs:	56
Drug Master File Entries:	59
Finished Product Suppliers / Packagers:	110
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	19
Patent Applications:	5,101
Drug Prices:	Drug price trends for ESOMEPRAZOLE MAGNESIUM
Drug Sales Revenues:	Drug sales revenues for ESOMEPRAZOLE MAGNESIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESOMEPRAZOLE MAGNESIUM
What excipients (inactive ingredients) are in ESOMEPRAZOLE MAGNESIUM?	ESOMEPRAZOLE MAGNESIUM excipients list
DailyMed Link:	ESOMEPRAZOLE MAGNESIUM at DailyMed

See drug prices for ESOMEPRAZOLE MAGNESIUM

See drug sales revenues for ESOMEPRAZOLE MAGNESIUM

Recent Clinical Trials for ESOMEPRAZOLE MAGNESIUM

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

Sponsor	Phase
Daewoong Pharmaceutical Co. LTD.	Phase 3
Icahn School of Medicine at Mount Sinai	Phase 2
University of Texas Southwestern Medical Center	Phase 3

See all ESOMEPRAZOLE MAGNESIUM clinical trials

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant	Application No.	Strength	Dosage Form
		EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL
		EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ESOMEPRAZOLE MAGNESIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for ESOMEPRAZOLE MAGNESIUM

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ESOMEPRAZOLE MAGNESIUM

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 24HR	Delayed-release Capsules	esomeprazole magnesium	20 mg	204655		2014-04-24
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 ESOMEPRAZOLE MAGNESIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Speclt	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	209495-001	May 10, 2019		DISCN	No	No
Sciegen Pharms Inc	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	217738-002	Oct 11, 2023	AB	RX	No	No
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011		RX	Yes	No

Expired US Patents for ESOMEPRAZOLE MAGNESIUM

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	4,853,230*PED
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006	7,411,070*PED
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014	5,877,192*PED

International Patents for ESOMEPRAZOLE MAGNESIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3932396	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)
Australia	2017285390	Stable orally disintegrating pharmaceutical compositions
European Patent Office	3471708	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for ESOMEPRAZOLE MAGNESIUM

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	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
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

ESOMEPRAZOLE MAGNESIUM Market Analysis and Financial Projection Experimental

Esomeprazole Magnesium Market Dynamics and Financial Trajectory

Market Overview

The esomeprazole magnesium market is poised for significant growth, driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Impact of COVID-19

The COVID-19 pandemic had an initial adverse impact on the esomeprazole market globally. 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 esomeprazole product sales, new product launches, and strategic developments[1][3][4].

Growth Drivers

Increasing Prevalence of GERD

One of the major drivers of the esomeprazole market is the increasing prevalence of gastroesophageal reflux disease (GERD). GERD is a chronic and highly prevalent disorder, particularly among the middle-aged and older population. In Western cultures, approximately 20% of adults suffer from GERD, making it one of the most common gastrointestinal disorders[1][3][4].

Novel Drug Delivery Systems

The rising acceptance of novel drug delivery systems is another significant factor contributing to market growth. Capsules, in particular, are gaining traction due to their fast-acting nature and better patient compliance compared to tablets. They are less likely to have an unpleasant taste or odor and are available in both branded and generic forms, making them more accessible and affordable[1][3].

Regulatory Approvals and Strategic Developments

Key players receiving approvals and market authorizations worldwide are increasing competition and boosting market growth. For example, Indchemie Health received FDA approval to manufacture and market esomeprazole magnesium capsules in 2021. Additionally, AstraZeneca entered into an agreement to out-license the rights to Nexium-authorized generics in Japan in June 2021[1][3].

Market Size and Growth Rate

The global esomeprazole market size was valued at USD 1.89 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 5.51% from 2024 to 2030. This growth is attributed to the rise in gastrointestinal disorders, including acid reflux, and the high success rates of esomeprazole in treating GERD[4].

Regional Market Analysis

North America

North America is expected to hold a significant share in the esomeprazole market, driven by the aging population, the surge in GERD patients, and strategic developments. The United States is a major contributor to regional growth due to the increasing adoption of novel drug delivery systems and the rising prevalence of gastrointestinal diseases among Americans[1][3][4].

Asia-Pacific

The Asia-Pacific region is expected to witness the fastest CAGR over the forecast period, driven by the rising geriatric population and high demand for esomeprazole products. Countries like Japan, where around 11.41 million people were affected by GERD in 2022, are contributing significantly to this growth[4].

Financial Performance of Key Players

AstraZeneca

AstraZeneca's Nexium generated revenues of USD 1.33 billion in 2021, with the highest share in emerging markets. However, the company faced a setback in October 2023 when it agreed to pay USD 425 million to resolve around 11,000 litigations regarding its heartburn drugs Prilosec and Nexium, which caused chronic kidney disease. This will likely have a negative impact on the company’s market position[1][3][4].

Product Launches and Approvals

Recent product launches and approvals are further fueling market growth. For instance, in June 2023, the U.S. Food and Drug Administration (FDA) approved esomeprazole magnesium for delayed-release oral suspension, developed by Zydus Lifesciences Limited, for the treatment of patients with esophagus and stomach problems[4].

Capsule Segment Growth

The capsule segment is expected to grow significantly due to the advantages offered by these over other dosage types. Capsules are fast-acting, break down quickly, and are less likely to have an unpleasant taste or odor. This segment is supported by product launches, company acquisitions, and research and development associated with esomeprazole capsules[1].

Clinical Trials and Research

Clinical trials continue to play a crucial role in the market's growth. For example, Onconic Therapeutics Inc. sponsored a clinical trial in July 2022 evaluating the efficacy and safety of JP-1366 20 mg compared to esomeprazole 40 mg capsule in patients with erosive esophagitis[1].

Market Challenges

Despite the growth, the esomeprazole market faces challenges such as litigation and safety concerns. AstraZeneca's recent settlement regarding chronic kidney disease associated with its heartburn drugs is a significant example of these challenges[4].

Key Takeaways

• The esomeprazole market is expected to grow at a CAGR of 5.51% from 2024 to 2030.
• The increasing prevalence of GERD and the rising acceptance of novel drug delivery systems are key growth drivers.
• North America and the Asia-Pacific region are significant markets due to their aging populations and high demand for esomeprazole products.
• Recent product launches and approvals, such as the FDA approval of esomeprazole magnesium for delayed-release oral suspension, are boosting market growth.
• The capsule segment is expected to grow significantly due to its advantages over other dosage types.

FAQs

What is the expected CAGR of the esomeprazole market from 2024 to 2030?

The esomeprazole market is expected to grow at a CAGR of 5.51% from 2024 to 2030[4].

How did COVID-19 impact the esomeprazole market?

COVID-19 initially disrupted the market by limiting access to pharmacies and causing medicine shortages. However, the market has since recovered due to increased product sales, new product launches, and strategic developments[1][3][4].

What are the main drivers of the esomeprazole market growth?

The main drivers include the increasing prevalence of GERD, the rising acceptance of novel drug delivery systems, and regulatory approvals and strategic developments[1][3][4].

Which region is expected to witness the fastest CAGR in the esomeprazole market?

The Asia-Pacific region is expected to witness the fastest CAGR over the forecast period due to the rising geriatric population and high demand for esomeprazole products[4].

What is the significance of the capsule segment in the esomeprazole market?

The capsule segment is expected to grow significantly due to its fast-acting nature, better patient compliance, and lack of unpleasant taste or odor compared to other dosage types[1].

Sources

1. Mordor Intelligence: Esomeprazole Market - Size, Share & Brands.
2. FDA: NEXIUM - accessdata.fda.gov.
3. Mordor Intelligence: Esomeprazole Market Size | Mordor Intelligence.
4. Grand View Research: Esomeprazole Market Size, Share & Growth Report, 2030.