Esomeprazole sodium - Generic Drug Details

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

Esomeprazole sodium is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Deva Holding As, Eugia Pharma, Gland Pharma Ltd, Mylan, Slate Run Pharma, Sun Pharm, and Astrazeneca, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for esomeprazole sodium. Five suppliers are listed for this compound.

Summary for esomeprazole sodium

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	180
Clinical Trials:	8
Patent Applications:	5,960
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for esomeprazole sodium
What excipients (inactive ingredients) are in esomeprazole sodium?	esomeprazole sodium excipients list
DailyMed Link:	esomeprazole sodium at DailyMed

Recent Clinical Trials for esomeprazole sodium

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

Sponsor	Phase
Livzon Pharmaceutical Group Inc.	Phase 3
BioPharma Services, Inc	Phase 1
Food and Drug Administration (FDA)	Phase 1

See all esomeprazole sodium clinical trials

Pharmacology for esomeprazole sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for esomeprazole sodium

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 SODIUM

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 esomeprazole sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	204657-002	Aug 10, 2016	AP	RX	No	No
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005		DISCN	Yes	No
Gland Pharma Ltd	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	203349-001	Apr 1, 2020		RX	No	Yes
Accord Hlthcare	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	205379-001	Sep 25, 2015		DISCN	No	No
Mylan	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	202686-001	May 17, 2017		DISCN	No	No
Slate Run Pharma	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	215732-001	Feb 10, 2022	AP	RX	No	Yes

Expired US Patents for esomeprazole sodium

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	021689-002	Mar 31, 2005	5,877,192*PED
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005	6,143,771

Esomeprazole sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Esomeprazole Sodium

Introduction to Esomeprazole Sodium

Esomeprazole sodium, sold under the brand name Nexium, is a proton pump inhibitor (PPI) used primarily for the management of gastroesophageal reflux disease (GERD), gastric protection, and the treatment of pathological hypersecretory conditions such as Zollinger-Ellison Syndrome[2].

Market Size and Growth

The esomeprazole sodium market has been experiencing significant growth and is anticipated to continue this trend. As of 2023, the market size was valued at USD 1,810.61 million and is projected to grow to USD 2,872.07 million by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period[3].

Key Drivers of Market Growth

Several factors are driving the growth of the esomeprazole sodium market:

Increasing Aging Population and Lifestyle Changes

The aging population and altering lifestyles, particularly among working individuals with hectic schedules and limited time for balanced meals, are leading to increased health complications related to digestive systems and acidity disorders. This has created a critical need for medications like esomeprazole that reduce stomach acid levels[3].

Rising Prevalence of GERD and Peptic Ulcers

The rising incidence of GERD and peptic ulcers is a major factor contributing to the market growth. In the United States, GERD is one of the most highly diagnosed digestive disorders, with a prevalence rate of 20%. Similarly, the prevalence of peptic ulcer diseases has been significant, facilitating sustainable demand for esomeprazole[3].

Technological Advancements and Healthcare Infrastructure

Technological advancements in medicine and improvements in healthcare infrastructure are also boosting market growth. The availability of latest technologies in developed and developing countries, along with growing government initiatives to promote healthcare, is fueling the demand for esomeprazole[1].

Market Segmentation

The esomeprazole sodium market is segmented based on several criteria:

Type Outlook

• Purity: 99%
• Purity: Above 99%
• Others[1]

Dosage Outlook

• Tablets
• Capsules
• Others[1]

Application Outlook

• Gastro Oesophageal Reflux Disease (GERD)
• Duodenal Ulcers
• Others[1]

Distribution Channel Outlook

• Hospitals & Clinical Pharmacies
• Online
• Over-the-Counter (OTC)[1]

Regional Outlook

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • Italy
  • France
  • BENELUX
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Rest of LATAM
• Middle East & Africa
  • Saudi Arabia
  • U.A.E.
  • South Africa
  • Rest of MEA[1]

Regional Market Performance

North America

North America dominates the global esomeprazole sodium market, driven by the high prevalence of GERD and peptic ulcers in the region. According to the Centre for Disease Control, around 25 million people in the United States are expected to have peptic ulcers at least once in their lifetime[3].

Asia Pacific

The Asia Pacific region is projected to be the fastest-growing region, driven by the growing elderly population and rising cases of gastroesophageal reflux. The increasing number of companies engaging in the production of esomeprazole in this region is expected to positively impact market growth[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

Adverse Effects of Long-Term Use

Long-term use of esomeprazole has been associated with adverse effects such as increased susceptibility to bacterial infections, reduced absorption of micronutrients like iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia, which may contribute to osteoporosis and bone fractures[2].

Rebound Effect

Rapid discontinuation of esomeprazole can cause a rebound effect, leading to a short-term increase in hypersecretion. This necessitates a gradual tapering of doses before discontinuing the medication[2].

Competitive Landscape

The market is highly competitive, with several key players focusing on strategies such as mergers and acquisitions, joint ventures, new product launches, agreements, and partnerships to retain their market position and expand their product base. Some of the leading companies in the market include:

• EsteveQuímica
• Everest Organics
• Jubilant Pharma
• Cemex Pharma
• Anuja Healthcare
• Zhejiang Davi Pharmaceutical
• Rajasthan Antibiotics
• Sainor Life Sciences
• Hema Pharmaceuticals[1]

SWOT and Porter’s Five Forces Analysis

The market report includes a detailed SWOT analysis and Porter’s Five Forces analysis to provide insights into the strengths, weaknesses, opportunities, and threats of the leading players. These analyses help in understanding the competitive dynamics and the overall market structure[1].

Impact of COVID-19

The COVID-19 pandemic has significantly impacted the pharmaceutical and healthcare sector, including the esomeprazole sodium market. The pandemic has led to increased investments in research and development, improvements in healthcare infrastructure, and a growing need for early diagnosis and precision medicine. These factors have contributed to the market growth during the pandemic[1].

Key Takeaways

• The esomeprazole sodium market is expected to grow significantly, driven by the increasing aging population, lifestyle changes, and rising prevalence of GERD and peptic ulcers.
• North America dominates the market, while the Asia Pacific region is expected to be the fastest-growing.
• The market faces challenges such as adverse effects of long-term use and rebound effects upon discontinuation.
• Key players are focusing on strategic developments to maintain their market position.

FAQs

1. What is the primary use of esomeprazole sodium? Esomeprazole sodium is primarily used for the management of gastroesophageal reflux disease (GERD), gastric protection, and the treatment of pathological hypersecretory conditions such as Zollinger-Ellison Syndrome[2].

2. What is the projected market size of esomeprazole sodium by 2032? The market is anticipated to grow to USD 2,872.07 million by 2032, exhibiting a CAGR of 5.3% during the forecast period[3].

3. Which region dominates the global esomeprazole sodium market? North America dominates the global esomeprazole sodium market, driven by the high prevalence of GERD and peptic ulcers in the region[3].

4. What are the major challenges faced by the esomeprazole sodium market? The market faces challenges such as adverse effects of long-term use, rebound effects upon discontinuation, and the need for careful dose tapering[2].

5. Who are some of the key players in the esomeprazole sodium market? Key players include EsteveQuímica, Everest Organics, Jubilant Pharma, Cemex Pharma, Anuja Healthcare, and others[1].

Cited Sources

1. Reports and Data, "Esomeprazole Sodium Market Size, Share, Industry Growth, Trend, Business Opportunities, Challenges, Drivers, and Restraint Research Report by 2027".
2. DrugBank Online, "Esomeprazole sodium".
3. Polaris Market Research, "Esomeprazole Market Size, Share, Global Analysis Report 2024-2032".