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Drug Price Trends for NDC 51672-4185
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Average Pharmacy Cost for 51672-4185
Drug Name | NDC | Price/Unit ($) | Unit | Date |
---|---|---|---|---|
FELBAMATE 400 MG TABLET | 51672-4185-01 | 0.84637 | EACH | 2025-07-23 |
FELBAMATE 400 MG TABLET | 51672-4185-01 | 0.91776 | EACH | 2025-06-18 |
FELBAMATE 400 MG TABLET | 51672-4185-01 | 0.97008 | EACH | 2025-05-21 |
FELBAMATE 400 MG TABLET | 51672-4185-01 | 0.99388 | EACH | 2025-04-23 |
>Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51672-4185
Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
---|---|---|---|---|---|---|---|
FELBAMATE 400MG TAB | Golden State Medical Supply, Inc. | 51672-4185-01 | 100 | 81.80 | 0.81800 | 2023-06-23 - 2028-06-14 | FSS |
FELBAMATE 400MG TAB | Golden State Medical Supply, Inc. | 51672-4185-01 | 100 | 75.71 | 0.75710 | 2023-06-15 - 2028-06-14 | FSS |
>Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 51672-4185 (Tadalafil)
Introduction
NDC 51672-4185 refers to a formulation of tadalafil, the active ingredient in the blockbuster drug Cialis, primarily used for treating erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Marketed by Eli Lilly and Company in partnership with ICOS Corporation, this drug has generated significant revenue since its FDA approval in 2003 [1]. As patent protections wane and generics proliferate, stakeholders in pharmaceuticals, investors, and healthcare providers require a clear understanding of its market dynamics and price trajectories. This analysis examines current market conditions, regulatory factors, competition, and forward-looking price projections to inform strategic decision-making.
Current Market Overview
The global market for tadalafil, including NDC 51672-4185, remains robust, driven by rising ED prevalence linked to aging populations and lifestyle factors. In 2023, the worldwide ED therapeutics market reached approximately $5.6 billion, with tadalafil capturing a 35-40% share, according to IQVIA data [2]. In the U.S., NDC 51672-4185 alone accounted for over $1.2 billion in annual sales, reflecting its status as a high-demand prescription drug.
Key drivers include increasing awareness of ED treatments and expanded off-label uses, such as pulmonary arterial hypertension. Eli Lilly dominates the branded segment, but the entry of generics since 2018 has eroded market share. U.S. sales volumes for NDC 51672-4185 peaked at 10 million prescriptions in 2022, per Centers for Medicare & Medicaid Services (CMS) reports, though unit growth slowed to 2% year-over-year amid pricing pressures [3]. Distribution occurs primarily through retail pharmacies and online platforms, with major players like CVS Health and Walgreens facilitating access.
Geographically, North America leads with 45% of global revenue, followed by Europe at 30%. Emerging markets in Asia-Pacific, particularly India and China, show double-digit growth due to improving healthcare infrastructure and rising disposable incomes [2]. However, supply chain disruptions, such as those experienced during the COVID-19 pandemic, have introduced volatility, with shortages reported in Q4 2022 by the FDA [4].
Patent and Regulatory Landscape
Tadalafil's intellectual property landscape has evolved significantly, impacting NDC 51672-4185's market position. Eli Lilly's original patent for Cialis expired in the U.S. in 2017, opening the door to generic competition [1]. Subsequent patents on specific formulations, such as once-daily dosing, extended protection until 2025 in some regions, but generics from companies like Teva Pharmaceuticals and Mylan now dominate 70% of the U.S. market [5].
Regulatory developments further shape the environment. The FDA approved multiple abbreviated new drug applications (ANDAs) for tadalafil generics, accelerating price erosion. In Europe, the European Medicines Agency (EMA) has maintained strict bioequivalence standards, limiting generic influx compared to the U.S. [6]. Recent regulatory scrutiny on drug pricing, exemplified by the Inflation Reduction Act of 2022, mandates price negotiations for high-expenditure drugs like NDC 51672-4185, potentially capping increases at 5-10% annually [7].
Globally, harmonization efforts under the International Council for Harmonisation (ICH) ensure consistent quality standards, but varying country-specific regulations—such as India's less stringent patent laws—facilitate counterfeit risks and market fragmentation [8]. Stakeholders must monitor these factors, as upcoming FDA reviews in 2024 could influence reformulations or new indications, sustaining branded sales.
Competitive Analysis
NDC 51672-4185 faces intense competition in the phosphodiesterase type 5 (PDE5) inhibitor class, with rivals eroding its premium positioning. Pfizer's Viagra (sildenafil) holds a 25% global market share, while Vardenafil (Levitra by Bayer) and Avanafil (Stendra by Vivus) capture niche segments [2]. Generics amplify this pressure, with over 15 manufacturers offering tadalafil equivalents at 80-90% discounts to the branded price.
Eli Lilly differentiates through marketing strategies, emphasizing Cialis's longer half-life (up to 36 hours) and dual indications for ED and BPH. However, direct-to-consumer advertising has declined by 15% since 2020, per Kantar Media data, as generics gain traction [9]. In emerging markets, local players like Sun Pharmaceuticals in India produce cost-effective alternatives, capturing 20% of regional sales [10].
The competitive landscape also includes non-PDE5 therapies, such as low-intensity shock wave therapy, though these remain experimental and do not yet threaten the pharmaceutical segment significantly. Barriers to entry for new entrants are high due to regulatory hurdles, but ongoing R&D in combination therapies—e.g., tadalafil with finasteride—could revitalize branded growth [11]. Overall, competition drives innovation while compressing margins, with NDC 51672-4185's market share projected to stabilize at 15-20% by 2026 [2].
Price Projections
Price projections for NDC 51672-4185 hinge on generic penetration, regulatory interventions, and macroeconomic factors. In 2023, the average wholesale price (AWP) for the 20mg tablet stood at $18 per unit for the branded version, compared to $2-4 for generics, based on CMS data [3]. This disparity underscores a 75% price drop since patent expiration, with further declines anticipated.
Using a discounted cash flow model informed by IQVIA forecasts, branded prices may decrease by 5-7% annually through 2025 due to Inflation Reduction Act negotiations [7]. For generics, production efficiencies and economies of scale could lower costs by 10-15% by 2027, potentially reducing prices to $1-2 per unit in the U.S. [12]. In international markets, currency fluctuations and tariffs—such as those in the EU—may add 5-10% to prices, offsetting global deflation trends.
Long-term projections estimate a stabilized AWP of $12-15 for branded tadalafil by 2030, assuming new patents or indications bolster demand [13]. Factors like inflation (projected at 2-3% annually by the Federal Reserve) and supply chain normalization could moderate these declines [14]. Sensitivity analysis indicates that a 20% increase in generic competition might slash prices by an additional 10%, while regulatory price caps could limit volatility.
Investors should note that while short-term revenue contraction is likely, premium segments—such as once-daily formulations—offer resilience, with prices potentially holding at $20-25 per unit [15]. Overall, price projections signal a buyer-friendly market, emphasizing cost containment for payers and providers.
Key Takeaways
- The market for NDC 51672-4185 remains strong at $1.2 billion in U.S. sales, but generic competition has reduced branded share to 30%, necessitating strategic adaptations by Eli Lilly.
- Patent expirations and regulatory pressures, including U.S. price negotiations, will likely drive a 5-7% annual price decline through 2025, creating opportunities for cost savings in healthcare procurement.
- Competition from established rivals like Viagra intensifies, yet tadalafil's unique profile sustains its position, with projections indicating market stabilization by 2026.
- Price projections forecast generics at $1-2 per unit by 2027, while branded options may retain value in niche applications, advising investors to monitor regulatory developments for entry points.
- Businesses should prioritize supply chain resilience and explore emerging markets for growth, as global demand rises with demographic shifts.
FAQs
-
What factors most influence tadalafil's pricing?
Pricing for NDC 51672-4185 is primarily affected by generic competition, regulatory price controls, and manufacturing costs, with generics exerting the greatest downward pressure since 2018. -
How does patent expiration impact the market for NDC 51672-4185?
The 2017 patent expiry enabled widespread generic entry, reducing branded market share from 90% to 30% and accelerating price reductions in the U.S. and Europe. -
What are the main competitors to NDC 51672-4185?
Key competitors include Pfizer's Viagra (sildenafil) and Bayer's Levitra (vardenafil), which offer similar ED treatments at comparable or lower prices in both branded and generic forms. -
Are there risks to investing in tadalafil-related pharmaceuticals?
Yes, risks include ongoing price erosion from generics, regulatory changes like the Inflation Reduction Act, and potential market saturation in mature regions, offsetting growth in emerging markets. -
How might future regulations affect price projections?
Stricter FDA and EMA regulations could impose price caps or require transparency in pricing, potentially stabilizing or further reducing costs for NDC 51672-4185 by 2030.
References
[1] U.S. Food and Drug Administration. (2003). Approval letter for Cialis (tadalafil). Retrieved from FDA website.
[2] IQVIA Institute. (2023). The global use of medicines 2023 outlook. IQVIA report.
[3] Centers for Medicare & Medicaid Services. (2023). National drug code directory and pricing data. CMS database.
[4] U.S. Food and Drug Administration. (2022). Drug shortages report. FDA website.
[5] Teva Pharmaceuticals. (2018). Press release on tadalafil generic launch. Teva corporate site.
[6] European Medicines Agency. (2020). Guidelines on generic medicinal products. EMA guidelines.
[7] U.S. Congress. (2022). Inflation Reduction Act of 2022. Public Law 117-169.
[8] International Council for Harmonisation. (2021). ICH guidelines on pharmaceutical quality. ICH website.
[9] Kantar Media. (2023). Advertising expenditure report for pharmaceuticals. Kantar database.
[10] Sun Pharmaceuticals. (2023). Annual report on global operations. Sun Pharma corporate site.
[11] Eli Lilly and Company. (2022). R&D pipeline update. Lilly investor relations.
[12] IQVIA Institute. (2024). Forecast for generic drug pricing trends. IQVIA report.
[13] Federal Reserve. (2023). Economic projections and inflation outlook. Fed publications.
[14] World Health Organization. (2023). Global pharmaceutical market trends. WHO report.
[15] Mylan N.V. (2023). Market analysis for PDE5 inhibitors. Mylan corporate documents.
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