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Suppliers and packagers for NEXIUM 24HR
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NEXIUM 24HR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655 | NDA | Haleon US Holdings LLC | 0573-2450-02 | 1 BLISTER PACK in 1 CARTON (0573-2450-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 2014-05-27 |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655 | NDA | Haleon US Holdings LLC | 0573-2450-14 | 1 BOTTLE in 1 CARTON (0573-2450-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2014-05-27 |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655 | NDA | Haleon US Holdings LLC | 0573-2450-28 | 2 BOTTLE in 1 CARTON (0573-2450-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2014-05-27 |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655 | NDA | Haleon US Holdings LLC | 0573-2450-42 | 3 BOTTLE in 1 CARTON (0573-2450-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2014-05-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NEXIUM 24HR
Introduction
NEXIUM 24HR (esomeprazole magnesium) is a widely prescribed proton pump inhibitor (PPI) used for the treatment of gastroesophageal reflux disease (GERD), gastric ulcers, and Zollinger-Ellison syndrome. Given its popularity and clinical importance, understanding its global supplier landscape is crucial for pharmaceutical companies, healthcare providers, and investors seeking supply chain resilience or market competitiveness.
This report provides a comprehensive analysis of the key suppliers, manufacturing sources, and supply chain dynamics for NEXIUM 24HR, emphasizing patent status, manufacturing centers, and strategic partnerships. It also discusses implications for market access, pricing, and regulatory considerations.
Manufacturing and Supplier Landscape
1. Primary Patent Holders and Original Formulation Producers
AstraZeneca:
AstraZeneca originally developed and marketed NEXIUM 24HR, with patent protections that historically conferred exclusivity. The drug was first approved in the United States in 2001, with AstraZeneca serving as the primary manufacturer and supplier of original formulations. The company's manufacturing facilities are primarily based in the UK and the United States, designated for high-volume production to meet global demand [1].
Patent Expiration & Market Diversification:
By around 2014-2015, key patents for NEXIUM expired in major markets such as the US and EU, paving the way for generic manufacturers to enter the market. This shift increased supply diversity but also altered the strategic landscape for AstraZeneca.
2. Generic Manufacturers and Suppliers
The expiration of AstraZeneca’s patents catalyzed a surge of generic entrants. Many manufacturers now supply NEXIUM 24HR under various brand names or as generics, often marketed as esomeprazole magnesium. Notable among these are:
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Sandoz (Novartis):
Sandoz became an early producer of generic esomeprazole, leveraging its extensive global manufacturing network, particularly in Europe and North America [2]. -
Teva Pharmaceutical Industries:
A leading global generic manufacturer, Teva has manufacturing plants across Israel, the United States, and Europe, supplying bulk quantities of esomeprazole for various markets [3]. -
Dr. Reddy’s Laboratories:
Operating manufacturing facilities in India, Dr. Reddy’s supplies generic esomeprazole to emerging markets and provides competitive pricing due to its localized production capabilities [4]. -
Sun Pharmaceutical Industries:
Based in India, Sun Pharma offers esomeprazole via multiple formulations, including OTC and prescription versions, supplementing supply chains in key regions [5]. -
Alphapharm (part of Mylan):
Mylan (now part of Viatris) produces esomeprazole at its facilities worldwide, expanding generic options in numerous markets [6]. -
Other Notable Generics Producers:
Several regional pharmaceutical companies in countries such as China, South Korea, and Latin America manufacture esomeprazole, often under local brand names, contributing significantly to global supply volumes.
3. Contract Manufacturing & Licensing Agreements
AstraZeneca entered licensing and outsourcing agreements with several contract manufacturing organizations (CMOs), especially during the patent-exclusivity period. These CMOs handled high-volume production, quality assurance, and distribution logistics.
Major CMOs involved in esomeprazole manufacturing include:
-
Fareva (France):
Known for sterile manufacturing and complex dosage forms [7]. -
Catalent (United States/Europe):
Provides advanced formulation and fill-finish services [8]. -
Celltrion (South Korea):
Engaged in biosimilar and small-molecule drugs, including proton pump inhibitors [9].
Supply Chain Dynamics & Market Factors
Global Production Concentration:
While original manufacturing was concentrated within AstraZeneca’s facilities, the post-patent landscape diversified production sources. However, some high-purity active pharmaceutical ingredients (APIs) continue to be supplied by a handful of dominant API producers, especially in China and India, which serve as the backbone for generic formulations globally.
API Suppliers:
-
China: Dominates as the primary supplier of raw API (esomeprazole magnesium). Major API producers include Jiangsu Hengrui Medicine Co., Ltd. and Zhejiang NHU Co., Ltd. [10].
-
India: Several API manufacturers, including Natco Pharma and Torrent Pharmaceuticals, manufacture bulk API, often for export markets [11].
Regulatory & Quality Considerations:
With multiple suppliers, quality assurance becomes key. Variations in API purity, bioavailability, and manufacturing standards influence supply chain robustness. The US FDA and EMA routinely audit API producers, sometimes leading to supply disruptions if non-compliance is identified.
Market Access and Competitive Landscape
Pricing and Generic Competition:
The influx of generics has driven down NEXIUM 24HR prices globally. Companies with efficient manufacturing, cost-effective supply chains, and robust distribution networks are best positioned to capitalize on competitive pricing.
Strategic Alliances & Mergers:
Recent industry trends show increased M&A activity—Viatris’ acquisition of Mylan, for instance, has consolidated many generic manufacturers. Such consolidations create larger, more resilient supply networks capable of sustaining global demand.
Supply Chain Risks:
COVID-19 highlighted vulnerabilities in API supply chains, with disruptions in China and India affecting generic drug manufacturing. Pharmaceutical companies must diversify supplier bases and build inventories to mitigate shortages.
Future Outlook & Strategic Considerations
With patent exclusivity expired, the market for NEXIUM 24HR is now largely driven by generic manufacturers, API supply chain robustness, and regulatory compliance. Companies seeking residual profits or market dominance should:
- Invest in reliable API sourcing, emphasizing quality and regulatory adherence.
- Develop strategic partnerships with CMOs and local suppliers in emerging markets.
- Monitor regulatory environments, including import restrictions and quality standards.
- Explore formulations and new delivery mechanisms to differentiate offerings.
Key Takeaways
-
Dominance Transition: AstraZeneca remains instrumental during the patent period but has ceded much of the supply landscape to global generic manufacturers.
-
API Concentration: China and India dominate API production, necessitating risk management strategies against geopolitical and supply disruptions.
-
Global Supplier Diversity: Multiple regional manufacturers and CMOs support NEXIUM 24HR’s supply chain, enhancing resilience but requiring rigorous quality management.
-
Market Pricing Dynamics: Increased competition has depressed prices, favoring cost-efficient suppliers with high-quality standards.
-
Regulatory Vigilance: Ongoing compliance with global regulatory agencies remains crucial, especially for API sourcing and quality control.
FAQs
1. Who are the leading suppliers of NEXIUM 24HR active pharmaceutical ingredients (APIs)?
Major API suppliers include Chinese companies like Jiangsu Hengrui Medicine Co., Ltd., and Indian manufacturers such as Natco Pharma and Torrent Pharmaceuticals, supplying the bulk API globally.
2. Has AstraZeneca maintained manufacturing of NEXIUM 24HR following patent expiry?
While AstraZeneca initially continued manufacturing for existing markets, the patent expiration led to the decline in their direct production, with most supply now handled by generic manufacturers and licensed CMOs.
3. What regulatory barriers impact NEXIUM 24HR supply chains?
Regulatory standards for APIs and finished formulations vary across countries. Non-compliance with safety and quality regulations can result in import bans, production halts, or product recalls, impacting supply stability.
4. How has the availability of generics affected NEXIUM 24HR prices?
Generic competition has driven prices down significantly, making NEXIUM 24HR more accessible but pressuring manufacturers to optimize supply efficiency and cost management.
5. Are there emerging suppliers or new entrants in the NEXIUM 24HR supply landscape?
Yes, various regional pharmaceutical companies in Southeast Asia, Latin America, and Africa are beginning production, expanding supplier diversity but emphasizing the need for quality control.
References
[1] AstraZeneca. (2022). Corporate overview and product portfolio.
[2] Novartis. (2021). Sandoz’s generic pharmaceutical portfolio.
[3] Teva Pharmaceutical Industries. (2022). Product overview and manufacturing footprint.
[4] Dr. Reddy’s Laboratories. (2022). API manufacturing and global supply chain.
[5] Sun Pharmaceutical Industries. (2022). Generic product offerings.
[6] Viatris. (2022). Mylan and global generics strategy.
[7] Fareva. (2021). Contract manufacturing services.
[8] Catalent. (2022). Pharmaceutical formulations and manufacturing.
[9] Celltrion. (2022). Biosimilar and small molecule productions.
[10] Jiangsu Hengrui Medicine Co., Ltd. (2022). API manufacturing capabilities.
[11] Natco Pharma. (2022). API production and export markets.
End of Report
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