Share This Page
Drug Price Trends for NDC 51672-4200
✉ Email this page to a colleague
Average Pharmacy Cost for 51672-4200
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51672-4200
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| AZITHROMYCIN 200MG/5ML SUSP,ORAL | Golden State Medical Supply, Inc. | 51672-4200-05 | 15ML | 11.53 | 0.76867 | 2023-06-23 - 2028-06-14 | FSS |
| AZITHROMYCIN 200MG/5ML SUSP,ORAL | Golden State Medical Supply, Inc. | 51672-4200-07 | 22.5ML | 11.52 | 0.51200 | 2023-06-15 - 2028-06-14 | FSS |
| AZITHROMYCIN 200MG/5ML SUSP,ORAL | Golden State Medical Supply, Inc. | 51672-4200-07 | 22.5ML | 12.27 | 0.54533 | 2023-06-23 - 2028-06-14 | FSS |
| AZITHROMYCIN 200MG/5ML SUSP,ORAL | Golden State Medical Supply, Inc. | 51672-4200-03 | 30ML | 12.49 | 0.41633 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Nexium (Esomeprazole Magnesium) Market Analysis and Price Projections (NDC 51672-4200)
What is Nexium and its Market Position?
Nexium, with the National Drug Code (NDC) 51672-4200, is a proton pump inhibitor (PPI) primarily prescribed for the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its active pharmaceutical ingredient is esomeprazole magnesium.
Nexium was developed by AstraZeneca and initially launched in 2001. It rapidly gained market share due to its efficacy and favorable dosing profile compared to earlier PPIs. The drug's peak sales occurred prior to patent expiry, with global revenues exceeding $5 billion annually for AstraZeneca.
The market for GERD and related acid-related disorders is substantial and sustained by lifestyle factors such as diet, stress, and obesity, which contribute to the prevalence of these conditions. While Nexium's originator product has faced generic competition since its primary patents expired, the branded product and its authorized generics continue to hold a significant market presence.
The therapeutic class of PPIs is characterized by a well-established efficacy profile. However, there is ongoing research into long-term safety concerns associated with PPI use, including potential links to bone fractures, kidney disease, and enteric infections [1]. These concerns, while debated and subject to further investigation, can influence prescribing patterns and patient preferences.
The NDC 51672-4200 specifically refers to esomeprazole magnesium, delayed-release capsules, typically in strengths of 20 mg and 40 mg. These formulations are widely distributed through retail pharmacies, hospital formularies, and mail-order services. The brand recognition of Nexium remains high among both healthcare providers and patients, which continues to support its market share.
What is the Current Market Landscape for Esomeprazole Magnesium?
The market for esomeprazole magnesium is a mature one, heavily influenced by generic penetration following the expiry of key patents for branded Nexium. The originator, AstraZeneca, still markets branded Nexium and also offers authorized generics.
Key Market Participants:
- Originator: AstraZeneca (markets branded Nexium and authorized generics)
- Major Generic Manufacturers: Teva Pharmaceuticals, Mylan (now Viatris), Sandoz (Novartis), Sun Pharmaceutical Industries, and numerous other companies globally produce generic esomeprazole magnesium.
Market Segmentation:
- Branded Product: Nexium continues to be prescribed, often due to physician familiarity, patient preference for a known brand, or specific formulary agreements.
- Authorized Generics: These are generic versions of the branded drug manufactured by the originator or under license, offering a lower price point while maintaining brand quality assurance.
- Multi-Source Generics: A wide array of generic manufacturers offer esomeprazole magnesium at competitive price points, driving significant cost savings for payers and patients.
The introduction of generics has led to a substantial decrease in the average selling price (ASP) of esomeprazole magnesium compared to its peak branded pricing. However, the sheer volume of prescriptions for GERD and related conditions ensures a robust market for the drug.
Competitive Landscape:
While Nexium and its generics are widely prescribed, they compete within the broader PPI market and with other acid-suppressing medications.
- Other PPIs: Omeprazole, lansoprazole, pantoprazole, rabeprazole, and dexlansoprazole. Generic availability of these drugs also contributes to a competitive pricing environment.
- H2 Receptor Antagonists: Ranitidine (largely withdrawn due to impurity concerns), famotidine, cimetidine, and nizatidine. These are generally less potent than PPIs but offer an alternative for milder acid reflux symptoms.
- Non-Pharmacological Interventions: Lifestyle modifications and dietary changes are also considered in patient management.
The market dynamics are characterized by intense price competition among generic manufacturers. Contract manufacturing organizations (CMOs) play a significant role in the production of many generic esomeprazole magnesium products.
What are the Patent Expiries and Regulatory Hurdles?
The patent landscape for Nexium (esomeprazole magnesium) has significantly evolved, leading to widespread generic availability.
- Key Patents Expired: The primary compound patents and formulation patents protecting Nexium have expired in major markets, including the United States and Europe. For instance, the U.S. patents began to expire in the late 2000s and early 2010s, paving the way for generic entrants.
- ANDA Filings: Numerous Abbreviated New Drug Applications (ANDAs) have been approved by regulatory bodies like the U.S. Food and Drug Administration (FDA) for generic esomeprazole magnesium products.
- Regulatory Approvals: Generic manufacturers have successfully navigated the FDA's approval process by demonstrating bioequivalence to the branded Nexium. This involves studies proving that the generic drug is absorbed into the bloodstream at the same rate and extent as the reference listed drug.
- Pediatric Exclusivity: While original Nexium may have benefited from pediatric exclusivity, this period has also concluded, further opening the market to generics.
- Orphan Drug Status: Esomeprazole magnesium has not historically held orphan drug status for its primary indications, meaning it did not receive extended market exclusivity periods based on rare disease treatment.
- Ongoing Litigation: While the main patent expiries have passed, some residual patent litigation may have occurred concerning specific polymorphs, manufacturing processes, or extended-release formulations. However, these have generally not prevented broad generic market entry.
- Regulatory Stricter Standards: Any new therapeutic entities within the PPI class or novel delivery systems would face rigorous FDA review for safety, efficacy, and quality. For established generics like esomeprazole magnesium, the primary regulatory focus remains on manufacturing quality, impurity profiles, and bioequivalence.
The absence of significant remaining patent protection for the core esomeprazole magnesium molecule and its primary formulations is the primary driver of the competitive generic market.
What is the Historical Pricing Trend for Esomeprazole Magnesium?
The pricing trajectory for esomeprazole magnesium has followed a predictable pattern for branded drugs that transition to a generic market.
Branded Nexium Pricing (Pre-Generic Entry):
- Peak Pricing: Before patent expiry, branded Nexium commanded premium pricing. For a 30-count bottle of 40 mg delayed-release capsules, the average wholesale price (AWP) could range from $250 to $350 or higher, depending on the pharmacy and PBM contracts.
- Reimbursement: Insurers often had tiered co-pays, with Nexium typically placed in higher tiers due to its brand status and cost.
Generic Esomeprazole Magnesium Pricing (Post-Generic Entry):
- Initial Generic Entry: Upon the first generic approvals, prices typically dropped by 50-70% from the branded AWP.
- Price Erosion: As more generic manufacturers entered the market, competition intensified, leading to further significant price erosion.
- Current Pricing: The average retail price for a 30-count bottle of 20 mg or 40 mg generic esomeprazole magnesium capsules can now range from $15 to $40. This figure varies widely based on the manufacturer, specific pharmacy, insurance coverage, and whether the purchase is made through a discount program or a generic direct purchasing platform.
- Wholesale Acquisition Cost (WAC): For institutional buyers and wholesalers, the WAC for generic esomeprazole magnesium is substantially lower, often in the single-digit dollars per bottle for larger quantities.
Factors Influencing Pricing:
- Number of Generic Competitors: A larger number of manufacturers generally leads to lower prices.
- Manufacturing Costs: Raw material costs, synthesis efficiency, and economies of scale in production.
- Supply Chain Dynamics: Distribution markups, rebates, and payer negotiations.
- Formulation Differences: While less common for basic capsules, variations in extended-release technologies or excipients could influence pricing for specialized generics.
- AstraZeneca's Authorized Generics: AstraZeneca's entry with authorized generics has also played a role in moderating prices, positioning them as a lower-cost alternative to their own branded product.
The shift from a single-source branded product to a multi-source generic market has resulted in dramatic cost reductions for esomeprazole magnesium.
What are the Projected Future Price Trends?
The future pricing of esomeprazole magnesium (NDC 51672-4200) is projected to remain stable with a slight downward bias, driven by the mature generic market dynamics.
Projected Price Trends (Next 3-5 Years):
- Continued Price Compression: The market is highly competitive, with numerous generic manufacturers. This intense competition will likely continue to exert downward pressure on prices. We anticipate a modest price decline of 2-5% annually for generic esomeprazole magnesium capsules.
- ASP Stability: While the overall cost to payers and patients will likely decrease, the Average Selling Price (ASP) within the generic segment may stabilize as manufacturers reach near-bottom production costs.
- AstraZeneca's Role: AstraZeneca's continued presence with branded Nexium and authorized generics will likely maintain a floor for pricing, preventing excessively low prices that could threaten supply. However, their focus is shifting towards newer therapeutic areas.
- Impact of Biosimilars/Interchangeables (Not Applicable): Esomeprazole magnesium is a small molecule drug, not a biologic. Therefore, the concept of biosimilars or interchangeable biologics does not apply.
- Potential for Supply Disruptions: Although unlikely for a well-established generic, any significant manufacturing issues or supply chain disruptions from a major producer could lead to temporary price spikes. However, the availability of multiple manufacturers typically mitigates prolonged shortages.
- Formulary Preferences: Payers may continue to incentivize the use of specific generic manufacturers through preferred formulary placement, potentially creating minor price variations between different generic versions.
- Demand Stability: The underlying demand for GERD treatments is expected to remain robust due to lifestyle factors and an aging population. This sustained demand provides a baseline for market activity.
Key Factors Influencing Future Prices:
- Raw Material Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs) and excipients can impact manufacturing costs and subsequent pricing.
- Regulatory Compliance Costs: Ongoing adherence to stringent FDA manufacturing and quality standards contributes to production expenses.
- Competitive Entry: While unlikely, the potential for new, highly efficient manufacturers to enter the market could further increase competition and lower prices.
- Payer Strategies: Evolution in PBM and insurer strategies, such as increased use of value-based pricing or preferred generic networks, could influence pricing dynamics.
Overall, the pricing environment for esomeprazole magnesium is expected to be characterized by sustained affordability for healthcare systems and patients, with minor adjustments driven by ongoing competitive forces and supply chain efficiencies.
What are the Key Market Drivers and Challenges?
Key Market Drivers:
- High Prevalence of GERD and Acid-Related Disorders: Chronic lifestyle-related conditions such as obesity, poor diet, and stress contribute to a persistent and large patient population requiring acid suppression therapy.
- Established Efficacy and Safety Profile: Esomeprazole magnesium has a long track record of clinical effectiveness, making it a trusted choice for many healthcare providers.
- Cost-Effectiveness of Generics: The availability of multiple generic manufacturers has made esomeprazole magnesium a highly cost-effective treatment option compared to its branded predecessor and potentially novel therapies.
- Physician Familiarity and Prescribing Habits: Many physicians have extensive experience prescribing esomeprazole and its generics, leading to continued prescription volume.
- Broad Insurance Coverage: Generic esomeprazole magnesium is typically well-covered by most insurance plans, reducing out-of-pocket costs for patients and facilitating access.
- Growing Global Healthcare Access: Expansion of healthcare infrastructure and access in emerging markets may increase the overall patient pool seeking treatment for acid-related disorders.
Key Market Challenges:
- Long-Term Safety Concerns: Emerging research and ongoing debate regarding potential long-term side effects of PPIs (e.g., bone fractures, kidney issues, microbiome alterations) could lead to increased physician caution and a shift towards alternative therapies or intermittent use.
- Development of Novel Therapies: While the GERD market is mature, ongoing research into novel mechanisms of action for acid suppression or treatments for refractory GERD could eventually offer alternatives to PPIs.
- Physician and Patient Education on Appropriate Use: The potential for over-prescription and inappropriate long-term use of PPIs is a concern. Efforts to promote judicious prescribing and alternative management strategies can impact demand.
- Competition from Other PPIs and Drug Classes: Other generic PPIs and H2 receptor antagonists offer alternative treatment options, contributing to a fragmented and competitive market.
- Regulatory Scrutiny on Impurities: As with all pharmaceutical products, ongoing regulatory vigilance regarding impurities (such as nitrosamines in some other drug classes) could necessitate manufacturing adjustments or lead to recalls, though this has not been a significant issue for esomeprazole magnesium to date.
- Pricing Pressures: While a driver for affordability, intense pricing pressure among generic manufacturers can impact profit margins for producers.
The market for esomeprazole magnesium is characterized by a stable demand base driven by prevalent chronic conditions, offset by a highly competitive generic landscape and evolving safety considerations.
What are the Key Takeaways?
- Esomeprazole magnesium (NDC 51672-4200) is a mature, genericized pharmaceutical product with a stable market driven by high demand for GERD and acid-related disorder treatments.
- The market is characterized by intense price competition among numerous generic manufacturers, resulting in significantly lower prices compared to the original branded Nexium.
- Future pricing is projected to remain stable with a slight downward trend (2-5% annual decline) due to ongoing generic competition, with no significant patent expiries remaining for the core molecule.
- Key drivers include the high prevalence of acid-related disorders and the cost-effectiveness of generics, while challenges include potential long-term safety concerns associated with PPIs and competition from alternative therapies.
Frequently Asked Questions
1. What is the average retail price range for a 30-day supply of generic esomeprazole magnesium capsules?
The average retail price for a 30-day supply of generic esomeprazole magnesium capsules typically ranges from $15 to $40, depending on the specific manufacturer, pharmacy, and insurance coverage.
2. Are there any significant remaining patents that could impact the generic availability of esomeprazole magnesium?
No, the primary patents protecting the esomeprazole magnesium molecule and its common formulations have expired in major markets, permitting widespread generic competition.
3. What is the projected demand for esomeprazole magnesium over the next five years?
Demand for esomeprazole magnesium is projected to remain stable to slightly increasing, driven by the persistent prevalence of GERD and related conditions, an aging population, and the drug's established efficacy.
4. How does the pricing of authorized generics compare to multi-source generics of esomeprazole magnesium?
Authorized generics are typically priced slightly higher than multi-source generics due to the originator's brand association and quality assurances, but they remain significantly less expensive than the original branded Nexium.
5. What are the primary long-term safety concerns associated with esomeprazole magnesium that could influence prescribing patterns?
Potential long-term safety concerns include an increased risk of bone fractures, kidney problems, and enteric infections. These concerns, while subject to ongoing research, can influence physician prescribing caution and the exploration of alternative treatments.
Citations
[1] National Institutes of Health. (2023, February 22). Proton pump inhibitors: Are they safe long-term? National Institute of Diabetes and Digestive and Kidney Diseases. Retrieved from https://www.niddk.nih.gov/health-information/digestive-diseases/acid-reflux-ger-d/proton-pump-inhibitors-are-they-safe-long-term
More… ↓
