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Last Updated: December 22, 2024

OMEPRAZOLE MAGNESIUM Drug Patent Profile


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Which patents cover Omeprazole Magnesium, and what generic alternatives are available?

Omeprazole Magnesium is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, and Perrigo R And D. and is included in eight NDAs.

The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Omeprazole Magnesium

A generic version of OMEPRAZOLE MAGNESIUM was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5th, 2009.

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  • What is the 5 year forecast for OMEPRAZOLE MAGNESIUM?
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Drug patent expirations by year for OMEPRAZOLE MAGNESIUM
Recent Clinical Trials for OMEPRAZOLE MAGNESIUM

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

SponsorPhase
AmgenEarly Phase 1
AnHeart Therapeutics Inc.Phase 1
Instituto Mexicano del Seguro SocialPhase 4

See all OMEPRAZOLE MAGNESIUM clinical trials

Pharmacology for OMEPRAZOLE MAGNESIUM
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
Aurobindo Pharma Ltd OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 213201-001 Apr 28, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
P And L OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 206582-001 Jun 1, 2020 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Spil OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 210593-001 Jul 20, 2018 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo R And D OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 204152-001 Jul 30, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 078878-001 Jun 5, 2009 OTC No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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"

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