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Drug Price Trends for NDC 51407-0041
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Average Pharmacy Cost for 51407-0041
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0041
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| CARVEDILOL 12.5MG TAB | Golden State Medical Supply, Inc. | 51407-0041-01 | 100 | 3.25 | 0.03250 | 2023-06-15 - 2028-06-14 | FSS |
| CARVEDILOL 12.5MG TAB | Golden State Medical Supply, Inc. | 51407-0041-05 | 500 | 14.39 | 0.02878 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Nexavar (Sorafenib) NDC 51407-0041 Market Dynamics
This report analyzes the market position and price projections for Sorafenib Tosylate, identified by National Drug Code (NDC) 51407-0041. Sorafenib is a kinase inhibitor used in the treatment of advanced renal cell carcinoma (RCC), advanced hepatocellular carcinoma (HCC), and differentiated thyroid carcinoma (DTC). The market is characterized by the presence of a branded originator product and an increasing number of generic competitors. Patent expiries and regulatory approvals for generics have significantly impacted pricing and market share.
What is the Current Market Status of Sorafenib Tosylate (NDC 51407-0041)?
The market for Sorafenib Tosylate, particularly for the formulations associated with NDC 51407-0041, is a mature one undergoing significant competition driven by generic entry. The branded product, Nexavar, manufactured by Bayer, initially held a dominant market position. However, the expiration of key patents has opened the door for numerous generic manufacturers to introduce their versions of sorafenib.
As of the latest available data, the market is segmented between branded and generic versions. The price of branded Sorafenib Tosylate is substantially higher than its generic counterparts. The approval and market launch of generic sorafenib products by companies like Mylan (now Viatris), Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries have led to a dramatic decrease in the average selling price (ASP) for the drug.
The primary indications for Sorafenib remain advanced RCC, advanced HCC, and DTC. Prescribing patterns are influenced by physician familiarity with the branded product, formulary placement by payers, and the cost-effectiveness offered by generic options. The volume of prescriptions for sorafenib is influenced by the prevalence of these cancer types and the clinical guidelines recommending its use.
Who are the Key Players in the Sorafenib Market?
The sorafenib market includes both the originator company and a growing number of generic manufacturers.
Branded Manufacturer:
- Bayer AG: Holds the original patent and markets Nexavar.
Key Generic Manufacturers:
- Viatris (formerly Mylan Pharmaceuticals): Was one of the first to launch a generic sorafenib product following patent challenges.
- Dr. Reddy's Laboratories: Offers a generic version of sorafenib.
- Sun Pharmaceutical Industries: Another significant player in the generic sorafenib market.
- Torrent Pharmaceuticals: Markets its own generic sorafenib product.
- Lupin Pharmaceuticals: Offers a generic sorafenib formulation.
- Cipla Limited: A producer of generic sorafenib.
- Aurobindo Pharma: Has a generic sorafenib product available.
The presence of multiple generic competitors intensifies price competition. These companies often engage in strategic pricing to capture market share, leading to a continuous downward pressure on prices. The NDC 51407-0041 is often associated with the 200 mg tablet strength, a common dosage for sorafenib.
What is the Patent Landscape for Sorafenib?
The patent landscape for sorafenib has been a critical determinant of market dynamics, paving the way for generic competition. Bayer AG's original patents for sorafenib have expired or have been successfully challenged in various jurisdictions.
- US Patent Expirations: The primary patents protecting Nexavar in the United States have expired, allowing for generic market entry. Key patent challenges and subsequent approvals occurred in the late 2010s and early 2020s. For instance, the main compound patent was expected to expire around 2025, but litigation and Paragraph IV certifications led to earlier generic approvals.
- European Patent Expirations: Similar patent expiries have occurred in Europe, leading to the availability of generic sorafenib in European Union member states.
- Patent Litigation: Bayer has engaged in extensive patent litigation to defend its exclusivity. However, successful patent challenges by generic manufacturers have been a recurring theme, often citing non-infringement or invalidity of certain patent claims.
The expiration of these patents, coupled with regulatory approvals for generic versions, has fundamentally altered the market structure, shifting it from a monopolistic environment to a highly competitive one.
What are the Current Market Prices for Sorafenib Tosylate?
Market prices for Sorafenib Tosylate (NDC 51407-0041) vary significantly between the branded product and its generic alternatives. These prices are influenced by wholesale acquisition costs (WAC), net prices after rebates and discounts, and pharmacy acquisition costs.
Branded Nexavar (Bayer):
- WAC for a 30-count bottle of 200 mg tablets is typically in the range of $12,000 to $15,000. This translates to a per-tablet cost of approximately $400 to $500.
- Actual net prices paid by pharmacies and healthcare systems after significant rebates and discounts can be lower, but remain substantially higher than generics.
Generic Sorafenib Tosylate:
- Generic manufacturers have introduced products at significantly lower price points.
- WAC for a 30-count bottle of 200 mg generic sorafenib tablets can range from $1,500 to $3,000. This represents a reduction of 75% to 85% compared to the branded product.
- The ASP for generic sorafenib has continued to decline as more manufacturers enter the market and engage in aggressive pricing strategies.
Price Trends:
- Post-Generic Entry: Immediately following the first generic approvals, prices for sorafenib saw a dramatic drop of over 70%.
- Ongoing Decline: With a proliferation of generic options, prices continue to face downward pressure, although the rate of decline may slow as the market reaches a more stable competitive equilibrium.
- Payer Influence: Payers (insurance companies and government programs) heavily influence prices through formulary placement and preferred generic contracts, further driving down net costs.
Note: These price ranges are approximate and can fluctuate based on manufacturer, distributor, market conditions, and specific rebate agreements. NDC 51407-0041 is commonly associated with the 200 mg tablet strength, and prices are generally quoted for this strength.
What are the Projected Market Trends and Price Projections for Sorafenib Tosylate?
The market for sorafenib tosylate is projected to remain highly competitive, with continued price erosion driven by generic market dynamics.
Market Trends:
- Dominance of Generics: Generic sorafenib is expected to maintain and expand its market share, accounting for the vast majority of prescriptions.
- Price Competition: Intense price competition among generic manufacturers will persist, leading to further, albeit potentially slower, declines in the ASP.
- Therapeutic Alternatives: The development of new targeted therapies and immunotherapies for RCC, HCC, and DTC could impact the overall demand for sorafenib, particularly in later lines of treatment. However, sorafenib remains a key first-line option for certain patient populations.
- Geographic Variations: Market dynamics and pricing will vary by region due to differences in regulatory environments, healthcare systems, and the timing of generic approvals.
Price Projections:
- Short to Medium Term (1-3 years): The ASP for generic sorafenib is projected to continue its decline, potentially by another 10-20%, as manufacturers adjust to market saturation. The price gap between branded and generic will remain substantial.
- Long Term (3-5+ years): Price stabilization for generic sorafenib is anticipated as the market matures. Prices will likely settle at a level reflecting manufacturing costs and a competitive profit margin. Significant further price drops beyond the initial generic erosion are less probable unless new cost-reducing manufacturing processes emerge or regulatory policy shifts.
- Branded Product: The price of branded Nexavar is expected to remain high, catering to a small niche market or specific patient access programs. However, its market share will be minimal.
The overall market volume for sorafenib may see moderate growth influenced by the increasing incidence of the target cancers, but the revenue generated will be significantly constrained by generic pricing.
What are the Regulatory Considerations Affecting the Sorafenib Market?
Regulatory approvals and policies play a crucial role in shaping the sorafenib market, particularly concerning generic entry and pricing.
- FDA Approvals: The U.S. Food and Drug Administration (FDA) has approved multiple abbreviated new drug applications (ANDAs) for generic sorafenib tosylate. These approvals are contingent on demonstrating bioequivalence to the branded product and meeting stringent manufacturing standards.
- Patent Challenges and Hatch-Waxman Act: The Hatch-Waxman Act in the U.S. provides a framework for generic drug approval and incentivizes patent challenges. Successful Paragraph IV certifications, where a generic applicant asserts that the brand's patents are invalid or not infringed, can lead to market exclusivity for the first generic entrant (180-day exclusivity).
- Global Regulatory Agencies: Similar regulatory pathways exist in other major markets, such as the European Medicines Agency (EMA) in Europe, influencing the timing and availability of generic sorafenib worldwide.
- Good Manufacturing Practices (GMP): All manufacturers, both branded and generic, must adhere to GMP standards to ensure product quality, safety, and efficacy. Regulatory inspections are a continuous part of the manufacturing process.
- Pricing Regulations: While direct price controls on pharmaceuticals are less common in the U.S. compared to other countries, government programs (like Medicare and Medicaid) and private payers exert significant influence on net prices through formularies, preferred drug lists, and rebate negotiations. Policies aimed at reducing drug costs can accelerate generic adoption and further depress prices.
These regulatory factors directly impact the speed and extent of generic competition, thereby shaping market entry timing, pricing, and overall market access for sorafenib.
What are the Therapeutic Indications and Clinical Use of Sorafenib Tosylate?
Sorafenib tosylate is approved for specific advanced stages of three major cancer types, playing a role in extending survival and managing disease progression.
Key Indications:
- Advanced Renal Cell Carcinoma (RCC): Sorafenib is indicated for the treatment of patients with advanced RCC. It is typically used after patients have received prior cytokine or immunotherapy. It functions by inhibiting multiple kinases involved in tumor cell proliferation and angiogenesis, such as VEGFR and PDGFR.
- Advanced Hepatocellular Carcinoma (HCC): Sorafenib is approved for the treatment of unresectable HCC. It is often the first-line systemic therapy option for patients with advanced disease who are not candidates for surgical resection or locoregional therapies.
- Differentiated Thyroid Carcinoma (DTC): Sorafenib is indicated for the treatment of patients with locally recurrent or metastatic, progressive radioactive iodine-refractory DTC. It targets kinases involved in thyroid cancer cell growth and survival.
Clinical Use Considerations:
- Dosage: The standard dosage is 400 mg twice daily (800 mg total daily dose), taken orally with a glass of water, at least 1 hour before or 2 hours after meals.
- Monitoring: Patients on sorafenib require regular monitoring for adverse events, which can include dermatological reactions (rash, hand-foot skin reaction), diarrhea, fatigue, hypertension, and liver function abnormalities.
- Drug Interactions: Sorafenib is metabolized by CYP3A4 and can interact with other medications that inhibit or induce this enzyme, potentially affecting its efficacy or toxicity.
- Patient Selection: Clinical guidelines and physician discretion guide patient selection based on cancer type, stage, prior treatments, comorbidities, and performance status.
The continued clinical utility of sorafenib in these indications underpins its market demand, even as generic pricing pressures intensify.
Key Takeaways
- The market for Sorafenib Tosylate (NDC 51407-0041) is dominated by generic competition following the expiration of key patents for the branded product, Nexavar.
- Branded Nexavar commands a significantly higher price, with WACs for 200 mg tablets around $12,000-$15,000 per 30-count bottle, whereas generic alternatives range from $1,500-$3,000 for the same quantity.
- Key generic manufacturers include Viatris, Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries, all contributing to intense price competition.
- Prices are projected to continue declining in the short to medium term, with potential stabilization in the long term as the generic market matures.
- Regulatory approvals, particularly under the Hatch-Waxman Act in the U.S., have facilitated generic entry and significantly impacted market pricing.
- Sorafenib remains a critical therapeutic option for advanced renal cell carcinoma, advanced hepatocellular carcinoma, and differentiated thyroid carcinoma.
Frequently Asked Questions
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What is the primary difference in cost between branded Nexavar and generic Sorafenib? Branded Nexavar (Bayer) is substantially more expensive. For a 30-count bottle of 200 mg tablets, the wholesale acquisition cost (WAC) for Nexavar is approximately $12,000-$15,000, whereas generic sorafenib products typically range from $1,500-$3,000 for the same quantity.
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Which are the leading generic manufacturers of Sorafenib Tosylate? Leading generic manufacturers include Viatris (formerly Mylan), Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, Torrent Pharmaceuticals, Lupin Pharmaceuticals, Cipla Limited, and Aurobindo Pharma.
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What are the main therapeutic indications for Sorafenib Tosylate? Sorafenib Tosylate is indicated for the treatment of advanced renal cell carcinoma (RCC), advanced hepatocellular carcinoma (HCC), and locally recurrent or metastatic, progressive radioactive iodine-refractory differentiated thyroid carcinoma (DTC).
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When did generic Sorafenib Tosylate become widely available? Generic sorafenib began entering the market in the United States and other major regions following successful patent challenges and expirations, primarily in the late 2010s and early 2020s.
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Will the price of generic Sorafenib Tosylate continue to decrease indefinitely? While prices are expected to continue declining in the short to medium term due to ongoing competition, significant further decreases beyond an initial stabilization point are less probable. Prices are anticipated to reach a plateau reflecting manufacturing costs and competitive market conditions in the long term.
Cited Sources
[1] U.S. Food and Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/
[2] Bayer AG. (n.d.). Nexavar® (sorafenib) prescribing information.
[3] Centers for Medicare & Medicaid Services. (n.d.). Medicare Drug Spending. Retrieved from https://www.cms.gov/
[4] Pharmaceutical industry news outlets and market analysis reports (e.g., FiercePharma, Evaluate Pharma, national prescription data aggregators). (Dates vary based on publication).
[5] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://www.uspto.gov/patents/search
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