Esomeprazole magnesium; naproxen - Generic Drug Details

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

Esomeprazole magnesium; naproxen is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Mylan, Sciegen Pharms Inc, and Horizon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for esomeprazole magnesium; naproxen

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for esomeprazole magnesium; naproxen
DailyMed Link:	esomeprazole magnesium; naproxen at DailyMed

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM; NAPROXEN

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; naproxen

Drug Class	Nonsteroidal Anti-inflammatory Drug Proton Pump Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for esomeprazole magnesium; naproxen

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

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIMOVO	Delayed-release Tablets	esomeprazole magnesium; naproxen	375 mg/20 mg and 500 mg/20 mg	022511	1	2010-11-05

US Patents and Regulatory Information for esomeprazole magnesium; naproxen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajanta Pharma Ltd	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	213699-002	Oct 6, 2022	AB	RX	No	No
Dr Reddys	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	204206-001	Feb 18, 2020	AB	RX	No	No
Actavis Labs Fl Inc	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	204470-001	Aug 24, 2022		DISCN	No	No
Mylan	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	204920-001	Jul 20, 2021		DISCN	No	No

Expired US Patents for esomeprazole magnesium; naproxen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	8,858,996
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	8,858,996
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	6,369,085*PED
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	8,557,285

Esomeprazole magnesium; naproxen Market Analysis and Financial Projection Experimental

Esomeprazole Magnesium and Naproxen Market Dynamics and Financial Trajectory

Introduction to Esomeprazole Magnesium and Naproxen

Esomeprazole magnesium and naproxen are two distinct pharmaceuticals that serve different medical purposes but can be interconnected in certain therapeutic contexts. Esomeprazole is a proton pump inhibitor (PPI) used primarily to treat gastroesophageal reflux disease (GERD), peptic ulcers, and other acid-related disorders. Naproxen, on the other hand, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain, inflammation, and fever.

Market Size and Growth Projections

The global esomeprazole market is anticipated to experience significant growth over the next decade. As of 2023, the market size was valued at approximately USD 1.91 billion and is expected to reach USD 2.872 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period[1][3][4].

Key Drivers of the Esomeprazole Market

Increasing Prevalence of Gastrointestinal Disorders

The rising incidence of GERD, peptic ulcers, and other gastrointestinal disorders is a major driver of the esomeprazole market. GERD, in particular, has a high prevalence rate, with around 20% of the population in the United States affected, making it one of the most highly diagnosed digestive disorders[1][4].

Aging Population and Lifestyle Changes

The aging population and changes in lifestyle, including hectic schedules and poor dietary habits, contribute significantly to the demand for esomeprazole. Elderly individuals are more vulnerable to gastrointestinal disorders, which fuels the growth of the esomeprazole market[1][4].

COVID-19 Impact

Studies have shown that individuals infected with COVID-19 have a higher risk of developing GERD, further increasing the demand for esomeprazole. This trend is expected to continue, providing new growth opportunities for the market[3].

Distribution Channels and Market Segments

Distribution Channels

The hospitals and clinical pharmacies segment holds a significant market share due to the increasing number of people seeking medical care for gastrointestinal issues. The accessibility of hospitals, especially in rural areas, driven by government initiatives to enhance healthcare infrastructure, is a key factor in this segment's growth[1].

Market Segments

The esomeprazole market is segmented based on product, application, and region. The GERD segment currently holds the largest market share and is expected to retain this position throughout the forecast period. The peptic ulcers segment is anticipated to grow at the fastest rate due to the increasing prevalence of peptic ulcer diseases[1][4].

Regional Analysis

North America

North America dominates the global esomeprazole market, driven by the high prevalence of GERD and peptic ulcers in the region. The robust healthcare infrastructure and advanced medical facilities in this region also contribute to its leading position[1][4].

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 presence of pharmaceutical companies in this region is also expected to positively impact market growth[1][4].

Naproxen and Esomeprazole Combination

Strategic Acquisitions and Collaborations

The market for esomeprazole is moderately fragmented, with several key players engaging in strategic acquisitions and collaborations. For instance, LG Chem acquired the patent rights for Vimovo, a drug that combines naproxen and esomeprazole, in December 2022. This combination is designed to reduce the risk of gastric ulcers associated with NSAID therapy[1].

Clinical Indications

The combination of naproxen and esomeprazole is indicated for the reduction in the occurrence of gastric ulcers in patients at risk due to continuous NSAID therapy. This combination leverages the acid-suppressing properties of esomeprazole to mitigate the gastrointestinal risks associated with naproxen use[2][5].

Financial Trajectory

Revenue Projections

The global esomeprazole market is expected to grow from USD 1.904 billion in 2024 to USD 2.872 billion by 2032, with a CAGR of 5.3% during the forecast period. This growth is driven by the increasing demand for effective treatments for gastrointestinal disorders and the expanding elderly population[1][3][4].

Market Competition

The market is expected to witness increased competition due to the presence of several market players and the entry of new companies into the production of esomeprazole. Strategic collaborations and acquisitions are key strategies employed by these players to maintain market share and drive growth[1][3].

Adverse Effects and Safety Considerations

Long-term Use Risks

Long-term use of esomeprazole has been associated with several adverse effects, including increased susceptibility to bacterial infections, reduced absorption of micronutrients like iron and vitamin B12, and an increased risk of developing hypomagnesemia and hypocalcemia, which can contribute to osteoporosis and bone fractures[2][5].

Interactions and Contraindications

Esomeprazole can interact with other medications, such as St John’s Wort and rifampin, which can reduce its efficacy. Additionally, long-term PPI therapy may be associated with an increased risk for osteoporosis-related fractures and other cardiovascular events[2][5].

Key Takeaways

• The global esomeprazole market is projected to grow significantly, driven by the increasing prevalence of GERD and peptic ulcers.
• The aging population and lifestyle changes are key factors contributing to market growth.
• North America dominates the market, with the Asia Pacific region expected to be the fastest-growing.
• The combination of naproxen and esomeprazole is crucial for reducing gastric ulcer risks associated with NSAID therapy.
• Long-term use of esomeprazole comes with several potential adverse effects that need careful consideration.

FAQs

What is the primary use of esomeprazole magnesium?

Esomeprazole magnesium is primarily used to treat gastroesophageal reflux disease (GERD), peptic ulcers, and other acid-related disorders by reducing stomach acid production.

How does the combination of naproxen and esomeprazole work?

The combination of naproxen and esomeprazole is designed to reduce the risk of gastric ulcers in patients taking continuous NSAID therapy by leveraging esomeprazole's acid-suppressing properties.

What are the potential adverse effects of long-term esomeprazole use?

Long-term use of esomeprazole can lead to increased susceptibility to bacterial infections, reduced absorption of micronutrients, and an increased risk of developing hypomagnesemia and hypocalcemia, which can contribute to osteoporosis and bone fractures.

Which region dominates the global esomeprazole market?

North America currently dominates the global esomeprazole market due to the high prevalence of GERD and peptic ulcers in the region.

What is the projected CAGR for the esomeprazole market from 2024 to 2032?

The esomeprazole market is expected to grow at a CAGR of 5.3% from 2024 to 2032.

Sources

1. Polaris Market Research: Esomeprazole Market Size, Share, Global Analysis Report 2024-2032
2. FDA: NEXIUM (esomeprazole magnesium) Label
3. Polaris Market Research: Esomeprazole Market Set $2,872.07 Million By 2032, CAGR 5.3%
4. The Brainy Insights: Esomeprazole Market Size, Trend Analysis, Insights
5. DrugBank: Esomeprazole: Uses, Interactions, Mechanism of Action