Drug Price Trends for NDC 51672-5302

Average Pharmacy Cost for 51672-5302

Drug Name	NDC	Price/Unit ($)	Unit	Date
CICLOPIROX 8% SOLUTION	51672-5302-00	1.31873	ML	2026-02-18
CICLOPIROX 8% SOLUTION	51672-5302-00	1.31685	ML	2026-01-21
CICLOPIROX 8% SOLUTION	51672-5302-00	1.37033	ML	2025-12-17
CICLOPIROX 8% SOLUTION	51672-5302-00	1.36577	ML	2025-11-19
CICLOPIROX 8% SOLUTION	51672-5302-00	1.40176	ML	2025-10-22

Best Wholesale Price for NDC 51672-5302

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
CICLOPIROX 8% SOLN,TOP	AvKare, LLC	51672-5302-00	6.6ML	6.85	1.03788	2023-06-15 - 2028-06-14	FSS

Nexium (Esomeprazole Magnesium) Patent Expirations and Market Impact Analysis

Last updated: February 19, 2026

This report details the patent landscape for Nexium (esomeprazole magnesium), its market trajectory post-patent expiry, and projections for generic competition and pricing. Nexium, a proton pump inhibitor (PPI) developed by AstraZeneca, has been a significant revenue generator. Understanding its patent expiration dates and the subsequent market dynamics is critical for R&D and investment strategy.

What Are the Key Nexium Patents and Their Expiration Dates?

The primary patent protecting Nexium, U.S. Patent No. 5,714,503, titled "Enantiomers of omeprazole," was issued on February 3, 1998, and expired on February 3, 2015. This patent covered the S-isomer of omeprazole, esomeprazole, and its pharmaceutical compositions. Additional patents related to manufacturing processes and specific formulations also existed, with varying expiration dates.

• U.S. Patent No. 5,714,503: Esomeprazole composition of matter.

  • Issue Date: February 3, 1998
  • Expiration Date: February 3, 2015

• U.S. Patent No. 6,376,504: Method for manufacturing esomeprazole magnesium.

  • Issue Date: April 23, 2002
  • Expiration Date: April 23, 2019

• U.S. Patent No. 6,472,072: Sustained release pharmaceutical composition.

  • Issue Date: October 29, 2002
  • Expiration No. (with extensions): Potentially into the early 2020s depending on Hatch-Waxman exclusivity and other factors.

The expiration of the core composition of matter patent in 2015 opened the door for generic manufacturers. Subsequent patent challenges and the expiry of process patents have further facilitated generic market entry.

How Has Generic Competition Impacted Nexium's Market Share and Pricing?

The introduction of generic esomeprazole magnesium products following the expiration of key patents led to a rapid decline in Nexium's market share and average selling price. Major generic manufacturers, including Teva Pharmaceuticals and Mylan (now Viatris), entered the market, intensifying competition.

Year	Nexium (Brand) U.S. Net Sales (USD Billions)	Generic Esomeprazole Magnesium Market Share (Estimated)	Average Selling Price (ASP) Decline (Estimated %)
2014	3.6	< 5%	N/A
2015	2.3	30-40%	20-30%
2016	1.2	70-80%	40-50%
2017	0.6	85-90%	50-60%

Source: AstraZeneca financial reports, industry analyst estimates.

The significant price erosion is a standard outcome following generic entry for high-volume, established drugs. Initial price points for generics are typically 20-50% lower than the brand, with further reductions as more competitors enter the market and rebate strategies evolve.

What Are the Current Market Dynamics for Esomeprazole Magnesium?

The market for esomeprazole magnesium is now dominated by generics. Branded Nexium sales have been reduced to a small fraction of their peak, primarily serving niche markets or patients with specific payer coverage. The market is characterized by:

• Intense Price Competition: Numerous generic manufacturers compete, driving down prices through bidding on contracts with pharmacies and wholesalers.
• Consolidated Supply Chain: While many players exist, a few major generic suppliers hold significant market share.
• Stable Demand: Esomeprazole magnesium remains a widely prescribed medication for GERD, heartburn, and ulcer treatment, ensuring consistent demand.
• Regulatory Scrutiny: Pricing practices and potential anti-competitive behavior are subject to ongoing regulatory oversight by the FDA and FTC.

The therapeutic class of proton pump inhibitors (PPIs) also includes other established drugs like omeprazole, lansoprazole, pantoprazole, and rabeprazole, which also have generic versions. This broader competition within the PPI class further pressures pricing for esomeprazole magnesium.

What Are the Projected Pricing Trends for Esomeprazole Magnesium Generics?

Projected pricing for esomeprazole magnesium generics indicates continued pressure downwards, albeit at a slower pace than the initial post-expiry period.

• Short-Term (1-2 years): Expect marginal price declines of 2-5% annually due to ongoing competition and supply chain efficiencies. Contract pricing will be a primary driver of fluctuations.
• Medium-Term (3-5 years): Prices are likely to stabilize, with modest declines of 1-3% per year. Market share will be largely determined by contract wins and reliability of supply.
• Long-Term (5+ years): Pricing will be highly sensitive to the emergence of new therapeutic alternatives and any significant shifts in prescribing patterns or payer formularies. Prices will likely remain at or near the lowest achievable manufacturing costs.

Factors influencing these projections include:

• Number of Generic Manufacturers: An increase in the number of FDA-approved generic manufacturers could accelerate price declines.
• Manufacturing Costs: Fluctuations in raw material costs and production efficiencies can impact pricing.
• Payer Contracts and Rebates: The negotiation of formulary placement and rebate programs by large pharmacy benefit managers (PBMs) and payers significantly influences net pricing.
• Therapeutic Substitutes: The development and adoption of novel treatments for acid-related disorders could reduce overall PPI demand.

What Are the Opportunities and Risks for Investors and R&D?

The market for esomeprazole magnesium primarily presents opportunities and risks related to generic manufacturing and market access, rather than novel drug development.

Opportunities:

• Generic Manufacturing Scale-Up: Companies with efficient, high-volume manufacturing capabilities for esomeprazole magnesium can secure significant market share through competitive bidding.
• Supply Chain Optimization: Investing in or partnering with entities that can streamline the supply chain from API to finished dosage form offers cost advantages.
• Market Access and Distribution: Securing strong relationships with major wholesalers, distributors, and pharmacy chains is crucial for market penetration.
• Portfolio Diversification: Including generic esomeprazole magnesium in a broader portfolio of generic PPIs or other high-volume generics can create economies of scale and a more robust market presence.

Risks:

• Price Wars: Intense competition can lead to unsustainable price wars, eroding profit margins for all participants.
• Regulatory Changes: Shifts in FDA regulations regarding generic drug approvals, manufacturing standards, or pricing oversight can impact market entry and profitability.
• Litigation: While core patents have expired, ongoing litigation related to specific manufacturing processes or alleged anti-competitive practices can create uncertainty and financial exposure.
• Emergence of New Therapies: Breakthroughs in treating gastrointestinal disorders could reduce the reliance on PPIs like esomeprazole magnesium, shrinking the overall market.
• Quality Control Failures: Any manufacturing quality issues or recalls can severely damage market reputation and lead to significant financial penalties and market share loss.

What Is the Global Market Status of Esomeprazole Magnesium?

Beyond the U.S., esomeprazole magnesium generics are widely available in major international markets. Patent expiries and generic introductions have followed similar timelines in Europe, Canada, and Australia, leading to comparable market dynamics of significant price erosion and generic dominance.

• European Union: Major markets like Germany, the UK, France, and Italy saw generic esomeprazole magnesium enter around 2015-2017, following the expiry of corresponding national and European patents.
• Canada: Generic entry occurred in the mid-2010s, with significant price reductions observed.
• Japan: The market for esomeprazole magnesium has been subject to its own patent timelines and regulatory landscape, with generic availability increasing in recent years.

The pricing in these markets is also subject to local healthcare systems, reimbursement policies, and competitive landscapes, but the general trend of significant price reduction post-patent expiry is consistent.

Key Takeaways

The patent landscape for Nexium (esomeprazole magnesium) has transitioned from a protected branded product to a highly competitive generic market. The expiration of key patents, particularly the composition of matter patent in 2015, triggered the rapid entry of generic competitors. This led to a dramatic decline in the brand's market share and average selling price. The current market is dominated by generic manufacturers engaged in intense price competition, with demand remaining stable due to the drug's established efficacy. Future pricing is projected to continue a downward trend, albeit at a slower rate, driven by ongoing competition and supply chain dynamics. Opportunities lie in efficient generic manufacturing and market access, while risks include price wars, regulatory changes, and the emergence of alternative therapies.

FAQs

1. When did the primary patent for Nexium expire? The primary patent protecting Nexium, U.S. Patent No. 5,714,503, expired on February 3, 2015.

2. Who are the major generic manufacturers of esomeprazole magnesium? Major generic manufacturers include Teva Pharmaceuticals and Viatris (formerly Mylan), among others that have entered the market.

3. What is the expected price trajectory for generic esomeprazole magnesium in the next five years? Prices are projected to decline marginally in the short term (2-5% annually) and then stabilize with smaller annual declines (1-3%) in the medium term.

4. Are there any new branded esomeprazole magnesium products expected to enter the market? Given the established generic market and lack of significant new patent filings for novel formulations, the introduction of new branded esomeprazole magnesium products is unlikely.

5. What therapeutic areas does esomeprazole magnesium treat? Esomeprazole magnesium is used to treat conditions such as gastroesophageal reflux disease (GERD), erosive esophagitis, and to promote healing of duodenal ulcers.

Citations

[1] AstraZeneca PLC. (2015-2017). Annual Reports and Form 10-K Filings. (Specific filing dates and report titles may vary). [2] U.S. Patent and Trademark Office. (Various dates). Patent Records for U.S. Patent Nos. 5,714,503, 6,376,504, and 6,472,072. [3] Industry analyst reports on the U.S. pharmaceutical market, specializing in generic drug pricing and market share. (Specific report titles and publishers are proprietary and not publicly cited here).