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Last Updated: December 22, 2024

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM Drug Patent Profile


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When do Naproxen And Esomeprazole Magnesium patents expire, and what generic alternatives are available?

Naproxen And Esomeprazole Magnesium is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Mylan, and Sciegen Pharms Inc. and is included in five NDAs.

The generic ingredient in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

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Summary for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
US Patents:0
Applicants:5
NDAs:5
Finished Product Suppliers / Packagers: 4
What excipients (inactive ingredients) are in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM?NAPROXEN AND ESOMEPRAZOLE MAGNESIUM excipients list
DailyMed Link:NAPROXEN AND ESOMEPRAZOLE MAGNESIUM at DailyMed
Drug patent expirations by year for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

US Patents and Regulatory Information for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

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

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naproxen and Esomeprazole Magnesium

Introduction

Naproxen and esomeprazole magnesium, a combination of a non-steroidal anti-inflammatory drug (NSAID) and a proton pump inhibitor (PPI), is a crucial medication for managing pain, inflammation, and gastrointestinal protection. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The global market for naproxen and esomeprazole magnesium is poised for significant growth. The naproxen market, in particular, is expected to witness high growth due to the increasing prevalence of arthritis and the growing focus on pain and swelling treatment. By 2031, the market size is projected to increase substantially, driven by these factors[2].

Revenue Forecast

The revenue forecast for naproxen and esomeprazole magnesium indicates a substantial increase. The esomeprazole market, for instance, is anticipated to grow from USD 1,904.40 million in 2024 to USD 2,872.07 million by 2032, exhibiting a CAGR of 5.3% during the forecast period[5].

Key Drivers

Several factors drive the market for naproxen and esomeprazole magnesium:

Increasing Prevalence of Arthritis

The rising prevalence of osteoarthritis and rheumatoid arthritis is a major driver. As the population ages, the demand for effective pain management and anti-inflammatory treatments increases[2].

Growing Need for Gastrointestinal Protection

The increasing prevalence of gastroesophageal reflux disease (GERD) and other gastrointestinal disorders also drives the demand for esomeprazole. GERD affects approximately 20% of adults in Western cultures, making it a significant market driver[3].

Availability as OTC and Prescription

Naproxen sodium is available as both an over-the-counter (OTC) and prescription drug, which expands its market reach. This dual availability is due to its well-established profile of benefits and risks over many years[2].

Market Segmentation

The market for naproxen and esomeprazole magnesium can be segmented in several ways:

By Formulation

The drug is available in various formulations, including delayed-release tablets. For example, Dr. Reddy's Laboratories offers Naproxen and Esomeprazole Magnesium Delayed-Release Tablets in 375 mg/20 mg and 500 mg/20 mg strengths[1].

By Disease Indication

The primary indications include osteoarthritis, rheumatoid arthritis, and gastrointestinal disorders such as GERD and peptic ulcers[2][3].

By Distribution Channel

The drug is distributed through various channels, including pharmacies, hospitals, and clinical settings. The hospitals and clinical pharmacies segment holds a significant market share due to the rising number of people with peptic ulcers and GERD[5].

Geographical Market

The geographical market for naproxen and esomeprazole magnesium varies significantly:

North America

North America is expected to be a dominant region, driven by the rising geriatric population and the surge in patients with GERD. The United States is a major contributor to regional growth due to factors such as the growing adoption of novel drug delivery systems and the increasing prevalence of gastrointestinal diseases[3][5].

Europe and Asia-Pacific

Europe and the Asia-Pacific region also show significant growth, though they are influenced by different factors such as supply chain disruptions, economic conditions, and local demand. The Asia-Pacific region is projected to be the fastest-growing region due to the growing elderly population and rising gastroesophageal reflux cases[2][5].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

Cardiovascular Risks

Naproxen, like other NSAIDs, poses cardiovascular risks such as myocardial infarctions and strokes, particularly in older populations. This risk must be carefully managed and communicated to patients[2].

Gastrointestinal Risks

Naproxen is associated with higher rates of upper gastrointestinal bleeding compared to other NSAIDs. The combination with esomeprazole helps mitigate this risk but does not eliminate it entirely[2].

Competition from Other Drugs

The availability of other drugs with lower risks of abdominal ulcers or allergic reactions competes with naproxen and esomeprazole magnesium. This includes steroids and other NSAIDs, which can hamper market growth[2].

Financial Trajectory

The financial trajectory of naproxen and esomeprazole magnesium is marked by expected growth with oscillating price trends due to global uncertainties:

Price Volatility

The price of naproxen sodium, for example, is expected to oscillate due to global market uncertainties, including supply chain disruptions and economic factors. As of Q1 2024, the price in the U.S. was around $35,550 USD/MT[2].

Cost-Effectiveness

A fixed-dose combination of naproxen and esomeprazole has been shown to be cost-effective and even dominant compared to other treatment options for osteoarthritis patients with increased gastrointestinal risk. This cost-effectiveness can drive market adoption and revenue growth[4].

Analyst Insights

Analysts predict continued volatility in the market due to global supply chain uncertainties, geopolitical shifts, and economic factors. The demand from downstream industries and escalating production costs will influence the price trend in the coming quarters[2].

Key Takeaways

  • Market Growth: The market is expected to grow significantly driven by the increasing prevalence of arthritis and gastrointestinal disorders.
  • Revenue Forecast: The revenue is anticipated to increase substantially, with the esomeprazole market expected to reach USD 2,872.07 million by 2032.
  • Key Drivers: Increasing prevalence of arthritis, growing need for gastrointestinal protection, and availability as OTC and prescription.
  • Challenges: Cardiovascular and gastrointestinal risks, competition from other drugs.
  • Geographical Market: North America is expected to be a dominant region, with significant growth also in Europe and the Asia-Pacific.

FAQs

What are the primary uses of naproxen and esomeprazole magnesium?

Naproxen and esomeprazole magnesium are primarily used for managing pain, menstrual cramps, and inflammatory conditions such as osteoarthritis and rheumatoid arthritis, while also providing gastrointestinal protection.

Why is naproxen and esomeprazole magnesium available as both a prescription and OTC drug?

Naproxen and esomeprazole magnesium are available as both prescription and OTC drugs due to their well-established profiling of benefits and risks over many years, leading to their approval for OTC use in several countries.

What are the major drivers of the naproxen and esomeprazole magnesium market?

The major drivers include the increasing prevalence of arthritis, the growing need for gastrointestinal protection, and the availability of the drug as both an OTC and prescription medication.

What are the potential risks associated with naproxen and esomeprazole magnesium?

Potential risks include cardiovascular events such as heart attacks and strokes, and gastrointestinal risks like upper gastrointestinal bleeding.

How does the geographical market vary for naproxen and esomeprazole magnesium?

The market varies significantly across North America, Europe, and the Asia-Pacific due to factors such as supply chain disruptions, economic conditions, and local demand.

Sources

  1. Dr. Reddy's Laboratories Announces the First Generic Launch of Naproxen and Esomeprazole Magnesium Delayed-Release Tablets in the U.S. Market. Business Wire.
  2. Generic NAPROXEN SODIUM INN entry, pharmaceutical patent, and market analysis. Drug Patent Watch.
  3. Esomeprazole Market - Size, Share & Brands. Mordor Intelligence.
  4. Efficiency of naproxen/esomeprazole in association for the treatment of osteoarthritis. PubMed.
  5. Esomeprazole Market Size, Share, Global Analysis Report 2024-2032. Polaris Market Research.

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