OMEPRAZOLE MAGNESIUM - Generic Drug Details

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

Omeprazole magnesium is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Covis, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, Perrigo R And D, and Astrazeneca, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-three drug master file entries for omeprazole magnesium. Fifty suppliers are listed for this compound.

Summary for OMEPRAZOLE MAGNESIUM

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Drug Master File Entries:	73
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	294
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMEPRAZOLE MAGNESIUM
What excipients (inactive ingredients) are in OMEPRAZOLE MAGNESIUM?	OMEPRAZOLE MAGNESIUM excipients list
DailyMed Link:	OMEPRAZOLE MAGNESIUM at DailyMed

Recent Clinical Trials for OMEPRAZOLE MAGNESIUM

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

Sponsor	Phase
Amgen	Early Phase 1
AnHeart Therapeutics Inc.	Phase 1
Instituto Mexicano del Seguro Social	Phase 4

See all OMEPRAZOLE MAGNESIUM clinical trials

Pharmacology for OMEPRAZOLE MAGNESIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for OMEPRAZOLE 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

Paragraph IV (Patent) Challenges for OMEPRAZOLE MAGNESIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRILOSEC OTC	Delayed-release Tablets	omeprazole magnesium	20 mg	021229	1	2012-03-30
PRILOSEC OTC	Delayed-release Capsules	omeprazole magnesium	20 mg	021229	1	2007-03-19

US Patents and Regulatory Information for OMEPRAZOLE MAGNESIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
P And L	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	206582-001	Jun 1, 2020		OTC	No	No
Perrigo R And D	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	204152-001	Jul 30, 2015		DISCN	No	No
Spil	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	210593-001	Jul 20, 2018		OTC	No	No
Aurobindo Pharma Ltd	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	213201-001	Apr 28, 2023		DISCN	No	No
Hetero Labs Ltd Iii	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	211732-001	Mar 25, 2020		OTC	No	No
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003		OTC	Yes	Yes
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-001	Mar 20, 2008		RX	Yes	No

Expired US Patents for OMEPRAZOLE MAGNESIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-001	Mar 20, 2008
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-002	Mar 20, 2008

OMEPRAZOLE MAGNESIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omeprazole Magnesium

Market Size and Growth Projections

The omeprazole market is poised for significant growth, driven by several key factors. As of 2023, the omeprazole market was valued at USD 1.06 billion and is expected to expand to USD 2.38 billion by 2036, growing at a Compound Annual Growth Rate (CAGR) of more than 6.4% during the forecast period of 2024-2036[1].

Growth Drivers

Increasing Prevalence of Chronic Diseases

The global rise in chronic diseases such as cancer, diabetes, and respiratory ailments is a major driver. According to the World Health Organization (WHO), by 2050, these diseases are expected to account for 90% of all global fatalities, which will increase the demand for medications like omeprazole[1].

Clinical Trials and Therapeutic Applications

Positive results from clinical trials, particularly in the treatment of Helicobacter pylori infections, are anticipated to boost the demand for omeprazole. For instance, RedHill Biopharma's phase 3 findings for the Talicia capsule, which combines antibiotics and a proton pump inhibitor, highlight the potential of omeprazole in H. pylori elimination therapy[1].

Dosage Forms and Preferences

The capsule segment is expected to dominate the market, projected to occupy 52% of the market share by 2036. The convenience and ease of handling of capsules, as well as tablets, contribute to their popularity. The global medication use is expected to increase, with more than half of the world's population taking more than one dose of medication per day by 2020[1].

Regional Market Dynamics

North America

North America is anticipated to hold the largest share of the omeprazole market, with a projected 59.3% market share during the forecast period. The prevalence of H. pylori infections and peptic ulcers in the US, affecting around 4.5 million individuals annually, drives this growth. Additionally, online services that help reduce prescription costs further bolster the market[1].

Asia Pacific (APAC)

The APAC region is expected to hold a significant share of 28.6% by 2036. Growing awareness about treating gastroesophageal reflux disease (GERD) and other acid-related conditions, along with increased focus by key market players to expand their product portfolios, are driving market growth in this region. Products like Vonoprazan, FDA-cleared for GERD treatment, are gaining traction in countries like Japan and other Asian nations[1].

Over-the-Counter (OTC) Market

The OTC market for omeprazole is substantial, with an annual market size of approximately $550 million. Recent FDA approvals for OTC omeprazole products, such as those by PL Developments and Perrigo Company, are set to enhance market accessibility and convenience. For example, Perrigo's Omeprazole Magnesium Delayed-Release Mini Capsules, approved in 2022, offer a smaller and more preferred form of omeprazole for consumers[2][5].

Financial Trajectory

Revenue Projections

The omeprazole market is expected to see significant revenue growth, from USD 1.12 billion in 2024 to USD 2.38 billion by 2036. This growth is fueled by increasing demand for omeprazole in various therapeutic applications and the expanding reach of OTC products[1].

Company Financials and Strategies

Companies like PL Developments and Perrigo are enhancing their financial flexibility through strategic moves such as debt restructuring and new product launches. For instance, PL Developments completed an exchange offer for its senior secured notes, improving its financial health and positioning it for continued growth and strategic investments[2].

Market Competition and Innovation

The market is competitive, with key players focusing on product innovation and regulatory approvals. Perrigo's launch of the first-to-market mini capsule form of omeprazole exemplifies this strategy, providing a differentiated product that is 70% smaller than the traditional tablet form[5].

Challenges and Opportunities

Regulatory and Market Challenges

Despite the growth potential, the omeprazole market faces challenges such as regulatory hurdles, pricing pressures, and competition from other industry participants. Companies must navigate these challenges while maintaining product quality and reliability[5].

Opportunities for Expansion

The increasing demand for gastroesophageal disease treatments, particularly in the APAC region, presents significant opportunities for market expansion. Key players are intensifying their focus on this region, expanding their product portfolios and distribution networks to capitalize on the growing demand[1].

Key Players and Market Segments

Key Companies

Companies such as Metrochem API, Perrigo Company, RAKS Pharma, and Zhejiang Davi Pharmaceutical Co. Ltd. are prominent players in the omeprazole market. These companies are profiled in various market reports, highlighting their strategies and market positions[4].

Market Segments

The market is segmented by application (e.g., duodenal ulcer, gastric ulcer, GERD), product type (e.g., capsules, tablets, powder), and geography (e.g., North America, Europe, APAC). Understanding these segments is crucial for companies to tailor their strategies and product offerings to meet specific market needs[1][4].

Key Takeaways

• The omeprazole market is projected to grow significantly, driven by increasing chronic diseases and positive clinical trial results.
• The capsule segment is expected to dominate the market, with North America holding the largest share.
• The OTC market for omeprazole is substantial and growing, with recent FDA approvals enhancing market accessibility.
• Companies are focusing on product innovation, regulatory approvals, and financial strategies to maintain market competitiveness.
• The APAC region offers significant growth opportunities due to increasing awareness and demand for gastroesophageal disease treatments.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of omeprazole by 2036? A: The omeprazole market is expected to cross USD 2.38 billion by the end of 2036[1].

Q: Which region is expected to hold the largest share of the omeprazole market? A: North America is anticipated to hold the largest share of the omeprazole market during the forecast period[1].

Q: What is driving the growth of the omeprazole market? A: The growth is driven by increasing cases of chronic diseases, positive results from clinical trials, and the expanding OTC market[1].

Q: Which dosage form is expected to dominate the omeprazole market? A: The capsule segment is expected to dominate the market, occupying 52% of the market share by 2036[1].

Q: Who are some of the key players in the omeprazole market? A: Key players include Metrochem API, Perrigo Company, RAKS Pharma, and Zhejiang Davi Pharmaceutical Co. Ltd.[4].

Sources Cited

1. Research Nester, "Omeprazole Market Size & Share | Growth Forecasts 2036"
2. Drug Store News, "PL Developments receives FDA approval for over-the-counter omeprazole"
3. Stats N Data, "Omeprazole Magnesium Enteric Coated Tablets Market"
4. Market Research Intellect, "Global Omeprazole Magnesium (Cas 95382-33-5) Market Size And Forecast"
5. PR Newswire, "PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR OMEPRAZOLE MAGNESIUM DELAYED-RELEASE MINI CAPSULES"