Drug Price Trends for NDC 50228-0429

Average Pharmacy Cost for 50228-0429

Drug Name	NDC	Price/Unit ($)	Unit	Date
DROXIDOPA 100 MG CAPSULE	50228-0429-90	0.64272	EACH	2026-03-18
DROXIDOPA 100 MG CAPSULE	50228-0429-90	0.67350	EACH	2026-02-18
DROXIDOPA 100 MG CAPSULE	50228-0429-90	0.72301	EACH	2026-01-21
DROXIDOPA 100 MG CAPSULE	50228-0429-90	0.78385	EACH	2025-12-17
DROXIDOPA 100 MG CAPSULE	50228-0429-90	0.84042	EACH	2025-11-19
DROXIDOPA 100 MG CAPSULE	50228-0429-90	0.89134	EACH	2025-10-22
DROXIDOPA 100 MG CAPSULE	50228-0429-90	0.92519	EACH	2025-09-17

Best Wholesale Price for NDC 50228-0429

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

Nexium (Esomeprazole Magnesium) Patent Expiry and Market Landscape

Last updated: February 17, 2026

Nexium, the proton pump inhibitor (PPI) esomeprazole magnesium, is facing significant market shifts due to patent expiries. This analysis details its patent status, the emergence of generics, and projected market performance.

What is the Current Patent Status of Nexium?

Nexium (esomeprazole magnesium) has undergone multiple patent expiries, leading to widespread generic competition. The primary patents protecting the drug have expired, allowing for the introduction of numerous generic versions.

• US Patent No. 5,691,377: This key patent, related to the preparation of esomeprazole, expired on July 1, 2015 [1].
• US Patent No. 6,825,217: This patent, concerning a specific polymorphic form of esomeprazole magnesium, expired on October 28, 2021 [1].
• US Patent No. 7,790,742: This patent, related to methods of treating gastroesophageal reflux disease (GERD) with esomeprazole, expired on July 16, 2024 [1].

These expirations have cleared the path for multiple manufacturers to produce and market generic esomeprazole magnesium.

Who Are the Key Manufacturers of Generic Esomeprazole Magnesium?

Following the patent expiries, a significant number of pharmaceutical companies have entered the esomeprazole magnesium market with generic offerings. This has intensified competition and driven down prices.

Key manufacturers include:

• Aurobindo Pharma: Offers a generic version of esomeprazole magnesium.
• Dr. Reddy's Laboratories: Produces and distributes generic esomeprazole magnesium.
• Teva Pharmaceutical Industries: A major player in the generic drug market, Teva offers esomeprazole magnesium.
• Mylan N.V. (now Viatris): Has a generic version of the drug available.
• Sun Pharmaceutical Industries: Offers esomeprazole magnesium as part of its generic portfolio.
• Alembic Pharmaceuticals: Is also a manufacturer of generic esomeprazole magnesium.
• Amneal Pharmaceuticals: Markets its own generic version.

The presence of these and other manufacturers signifies a highly competitive generic landscape.

What is the Market Share of Branded Nexium vs. Generics?

Since the primary patent expiries, the market share for branded Nexium has drastically declined, with generic versions now dominating.

• Pre-Generic Entry (circa 2014): Branded Nexium held near-monopoly status, generating substantial revenue.
• Post-Generic Entry (2015 onwards): Market share for branded Nexium has eroded significantly, estimated to be below 10% of the total esomeprazole magnesium market in the US. Generic versions collectively account for over 90% of prescriptions and sales [2].

This shift is typical for branded drugs once their exclusivity periods end.

How Have Prices for Esomeprazole Magnesium Changed?

The introduction of generic competition has led to a dramatic decrease in the average selling price (ASP) of esomeprazole magnesium.

• Branded Nexium (Pre-2015): Prices for branded Nexium were substantial, reflecting its market exclusivity and R&D investment. For instance, a 30-count bottle of 40mg Nexium capsules could cost upwards of $250-$300 [3].
• Generic Esomeprazole Magnesium (Post-2015): The ASP has fallen by an estimated 80-90% since the advent of generics. A comparable 30-count bottle of 40mg generic esomeprazole magnesium can now be purchased for between $10 and $30, depending on the manufacturer, dosage form, and pharmacy [4].

This price deflation is a direct consequence of increased supply and competition.

What Are the Projected Market Trends for Esomeprazole Magnesium?

The market for esomeprazole magnesium is expected to remain stable in terms of volume but will likely continue to be characterized by low pricing due to entrenched generic competition.

• Volume: The demand for PPIs, including esomeprazole, is generally stable due to the chronic nature of conditions like GERD and peptic ulcers. The volume of esomeprazole magnesium prescribed is unlikely to see significant fluctuations in the near to medium term.
• Pricing: Prices are expected to remain depressed. Intense competition among numerous generic manufacturers will prevent significant price increases. Any upward pressure might be localized to specific SKUs or formulations where supply is temporarily constrained, but this is not expected to be a market-wide trend.
• Market Value: While volume remains stable, the overall market value for esomeprazole magnesium will continue to be significantly lower than during the branded era. The market value is projected to be in the range of several hundred million dollars annually in the US, a fraction of its peak revenue.
• Competition: New generic entrants are unlikely, given the mature nature of the market. However, consolidation among existing generic players could occur, potentially leading to minor price adjustments.

The market has fully transitioned to a generics-dominated model.

What Are the Potential Implications for R&D and Investment?

For R&D and investment, the esomeprazole magnesium market presents limited opportunities for new entrants or significant growth, primarily due to its commoditized generic status.

• R&D: There is minimal incentive for R&D into new formulations or delivery methods of esomeprazole magnesium itself, as the market is saturated with low-cost generics. Any R&D efforts would likely focus on next-generation acid suppressants or drugs for conditions that are refractory to PPIs.
• Investment:
  • Generic Manufacturers: Investment in companies that are efficient, low-cost producers of generic esomeprazole magnesium may yield steady, albeit modest, returns based on volume.
  • Branded Nexium (AstraZeneca): The originator company, AstraZeneca, has largely transitioned its focus to newer pipeline drugs and has minimal ongoing revenue from Nexium in key markets.
  • New Market Entrants: Entry into the esomeprazole magnesium market by new companies is not advisable due to extreme price pressure and established competition.
  • Mergers and Acquisitions: Opportunities might exist for larger generic players to acquire smaller competitors to gain market share or achieve economies of scale, but this is driven by cost optimization rather than market expansion.

The focus for investment is on operational efficiency and market share defense within the generic space.

What Are the Regulatory Considerations for Esomeprazole Magnesium?

Regulatory considerations for esomeprazole magnesium primarily revolve around maintaining compliance for generic drug manufacturing and marketing.

• FDA Approval Process: Generic manufacturers must obtain Abbreviated New Drug Applications (ANDAs) from the U.S. Food and Drug Administration (FDA). This requires demonstrating bioequivalence to the reference listed drug, Nexium [5].
• Manufacturing Standards: Facilities producing generic esomeprazole magnesium must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy [5].
• Labeling and Packaging: Generic products must have labeling that is substantially the same as the reference listed drug, with necessary modifications to reflect the generic manufacturer [5].
• Post-Market Surveillance: Like all pharmaceuticals, generic esomeprazole magnesium is subject to post-market surveillance and pharmacovigilance requirements to monitor for adverse events.
• Intellectual Property: While primary patents have expired, vigilance is required regarding any potential secondary patents (e.g., related to specific manufacturing processes, impurities, or novel formulations) that could still be in force or be litigated.

Navigating these regulatory pathways is standard for generic pharmaceutical operations.

Key Takeaways

• Nexium (esomeprazole magnesium) has experienced its key patent expiries, leading to widespread generic availability.
• The market is now dominated by numerous generic manufacturers, including Aurobindo, Dr. Reddy's, Teva, and Viatris.
• Branded Nexium's market share has fallen below 10%, with generics holding over 90%.
• Prices for esomeprazole magnesium have decreased by 80-90% since generic entry, with a 30-count bottle costing $10-$30.
• The market volume is stable, but market value remains low due to price competition.
• R&D and investment opportunities are minimal for new esomeprazole magnesium products; focus is on cost efficiency for generic players.
• Regulatory compliance, including FDA approval via ANDAs and adherence to cGMP, is critical for generic manufacturers.

Frequently Asked Questions

1. Will branded Nexium ever regain significant market share? No, branded Nexium will not regain significant market share. The market has transitioned to generics, and the price differential is too large for branded products to compete effectively in this therapeutic class.

2. Are there any remaining patents that could block generic competition for Nexium? While the primary patents have expired, secondary patents related to specific formulations or manufacturing processes could exist. However, these are unlikely to prevent the broad availability of generic esomeprazole magnesium, as evidenced by the multitude of current generic products. Litigation around such patents is a possibility but has not impeded market entry to date.

3. What is the typical dosage of generic esomeprazole magnesium prescribed? Common dosages for generic esomeprazole magnesium are 20 mg and 40 mg, administered once daily. The specific dosage depends on the patient's condition, such as the severity of GERD or the presence of erosive esophagitis.

4. Can a patient switch between different generic brands of esomeprazole magnesium without issue? Generally, yes. Generic drugs are required to be bioequivalent to the reference drug. Patients can typically switch between different generic brands of esomeprazole magnesium without experiencing a difference in efficacy or safety, provided they are the same strength and dosage form.

5. What are the primary therapeutic uses for esomeprazole magnesium? Esomeprazole magnesium is primarily used to treat conditions caused by excess stomach acid. These include gastroesophageal reflux disease (GERD), erosive esophagitis, Zollinger-Ellison syndrome, and as part of combination therapy for the eradication of Helicobacter pylori infection.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] IQVIA National Sales Perspectives (NSP) data (Proprietary market data, access requires subscription). [3] GoodRx. (n.d.). Nexium Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/nexium (Data reflects historical pricing trends). [4] Cost Plus Drugs by Mark Cuban. (n.d.). Esomeprazole Magnesium 20mg Tablet. Retrieved from https://costplusdrugs.com/ (Example of current generic pricing). [5] U.S. Food and Drug Administration. (n.d.). Generics. Retrieved from https://www.fda.gov/drugs/generic-drugs