MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE Drug Patent Profile

Which patents cover Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate, and what generic alternatives are available?

Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate is a drug marketed by Santarus and is included in one NDA.

The generic ingredient in MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE at DailyMed

Recent Clinical Trials for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

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

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 4
Yvonne Romero	Phase 4
Valeant Pharmaceuticals International, Inc.	Phase 4

See all MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE clinical trials

US Patents and Regulatory Information for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009		DISCN	No	No
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009		DISCN	No	No

Expired US Patents for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009

International Patents for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

See the table below for patents covering MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2396159	NOUVELLES FORMES POSOLOGIQUES DE BENZIMIDAZOLE SUBSTITUE (NOVEL SUBSTITUTED BENZIMIDAZOLE DOSAGE FORMS AND METHOD OF USING SAME)
Taiwan	200303220
Poland	357144

Supplementary Protection Certificates for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Magnesium Hydroxide, Omeprazole, and Sodium Bicarbonate

Introduction

The combination of magnesium hydroxide, omeprazole, and sodium bicarbonate is a potent formulation used to treat various gastrointestinal conditions, including gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). This article delves into the market dynamics and financial trajectory of this drug combination.

Market Overview

The global market for antacids and proton pump inhibitors (PPIs) is robust and growing, driven by increasing prevalence of gastrointestinal disorders and an aging population. The combination of omeprazole and sodium bicarbonate, often supplemented with magnesium hydroxide, is a key player in this market.

Role of Each Component

Omeprazole

Omeprazole is a PPI that works by decreasing the amount of acid produced by the stomach. It is highly effective in treating conditions like GERD, duodenal ulcers, and erosive esophagitis[1][2].

Sodium Bicarbonate

Sodium bicarbonate acts as an antacid, neutralizing excess acid in the stomach. It is often combined with omeprazole to provide immediate relief from heartburn and other acid-related symptoms[1].

Magnesium Hydroxide

Magnesium hydroxide is another antacid that can be included in these formulations. It is known for its neutralizing capacity and is used in various forms, including chewable tablets and suspensions. Magnesium hydroxide also has laxative properties and is used in wastewater treatment and as a flame retardant[3][4].

Market Growth and Projections

Global Magnesium Hydroxide Market

The global magnesium hydroxide market is projected to grow at a compound annual growth rate (CAGR) of 6.2% from 2024 to 2034, reaching a market value of USD 2,601.8 million by 2034. This growth is driven by increasing demand in environmental applications, pharmaceuticals, and the plastics and rubber sector[3].

Antacids and PPIs Market

The market for antacids and PPIs is also experiencing significant growth due to the rising incidence of gastrointestinal diseases. The combination of omeprazole and sodium bicarbonate, with or without magnesium hydroxide, is a major contributor to this growth.

Financial Trajectory

Revenue and Market Share

The revenue generated by omeprazole and sodium bicarbonate combinations is substantial, given their widespread use. With the inclusion of magnesium hydroxide, these formulations capture a larger market share in the antacids and PPIs segment. The financial trajectory is expected to remain positive, driven by increasing demand and the expanding patient population.

Cost and Pricing

The cost of production for these formulations can vary, but the inclusion of magnesium hydroxide can sometimes increase costs due to its high-grade requirements. However, the overall pricing strategy is competitive, balancing profitability with patient affordability[3].

Key Drivers and Restraints

Drivers

• Increasing Prevalence of Gastrointestinal Disorders: The growing incidence of GERD, ulcers, and other acid-related conditions drives the demand for effective treatments.
• Aging Population: Elderly patients are more sensitive to the effects of these medications, leading to increased usage.
• Environmental and Regulatory Factors: The eco-friendly properties of magnesium hydroxide are boosting its adoption in various sectors, including pharmaceuticals[3].

Restraints

• High Production Costs: The cost of high-grade magnesium hydroxide can be a limiting factor for smaller-scale applications.
• Availability of Alternatives: Competition from other antacids and PPIs may pose challenges in certain markets[3].

Regional Analysis

Asia-Pacific Region

The Asia-Pacific region is expected to dominate the magnesium hydroxide market, driven by rapid industrialization and stringent environmental regulations in countries like China and India. This region also sees a high demand for antacids and PPIs due to lifestyle changes and an increasing elderly population[3].

North America and Europe

These regions also contribute significantly to the market, with a strong focus on healthcare and the treatment of gastrointestinal disorders. The regulatory environment in these regions supports the use of magnesium hydroxide and omeprazole combinations.

Competitive Landscape

The market for magnesium hydroxide, omeprazole, and sodium bicarbonate is characterized by intense competition among global players. Key companies such as Martin Marietta, Konoshima Chemical, and ICL Group are focusing on innovation and regional expansion to maintain market share[3].

Technological Advancements

Innovations in production methods are enhancing the purity and effectiveness of magnesium hydroxide, expanding its potential applications. This includes better formulations of omeprazole and sodium bicarbonate combinations that offer improved efficacy and patient compliance[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of these drugs. Strict regulations ensure the safety and efficacy of these formulations, while also promoting the use of eco-friendly and non-toxic materials like magnesium hydroxide[3].

Patient Compliance and Efficacy

Efficacy

The combination of omeprazole, sodium bicarbonate, and magnesium hydroxide has been shown to be highly effective in treating gastrointestinal conditions. For example, omeprazole has been found to reduce gastric acidity significantly, with a median pH of 5.1 maintained for up to 14.9 hours[2].

Patient Compliance

Patient compliance is enhanced by the availability of various dosage forms, including capsules, packets, and chewable tablets. This flexibility makes it easier for patients to adhere to their treatment regimens.

Conclusion

The market for magnesium hydroxide, omeprazole, and sodium bicarbonate is robust and growing, driven by increasing demand for effective treatments of gastrointestinal disorders. The financial trajectory of these drugs is positive, with significant revenue generation and market share. However, the market is also subject to restraints such as high production costs and competition from alternatives.

Key Takeaways

• The combination of omeprazole, sodium bicarbonate, and magnesium hydroxide is highly effective in treating GERD, ulcers, and other acid-related conditions.
• The global magnesium hydroxide market is projected to grow at a CAGR of 6.2% from 2024 to 2034.
• The Asia-Pacific region is expected to dominate the market due to rapid industrialization and environmental regulations.
• Technological advancements and regulatory focus on environmental safety are driving the adoption of magnesium hydroxide.
• Patient compliance is enhanced by the availability of various dosage forms.

FAQs

Q: What conditions are treated with omeprazole and sodium bicarbonate?

A: Omeprazole and sodium bicarbonate are used to treat gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD)[1].

Q: How does magnesium hydroxide contribute to these formulations?

A: Magnesium hydroxide acts as an antacid and laxative, and its inclusion enhances the neutralizing capacity of the formulation. It also has eco-friendly properties that are beneficial in various applications[3][4].

Q: What is the projected growth rate of the magnesium hydroxide market?

A: The global magnesium hydroxide market is projected to grow at a CAGR of 6.2% from 2024 to 2034[3].

Q: Which regions are expected to dominate the market for these drugs?

A: The Asia-Pacific region, followed by North America and Europe, is expected to dominate the market due to rapid industrialization and stringent environmental regulations[3].

Q: What are the key drivers of the market for these drugs?

A: Key drivers include the increasing prevalence of gastrointestinal disorders, an aging population, and the eco-friendly properties of magnesium hydroxide[3].

Sources

1. Mayo Clinic: Omeprazole and sodium bicarbonate (oral route) - Mayo Clinic.
2. DailyMed: ZEGERID® with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide).
3. GlobeNewswire: Magnesium Hydroxide Market Projected to Reach USD 2,601.8 Million by 2034, Growing at a CAGR of 6.2% | Future Market Insights, Inc.
4. DrugBank: Magnesium hydroxide.