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Drug Price Trends for NDC 72647-0331
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Average Pharmacy Cost for 72647-0331
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 72647-0331
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE 4MG TAB | Golden State Medical Supply, Inc. | 72647-0331-01 | 100 | 24.76 | 0.24760 | 2023-06-15 - 2028-06-14 | FSS |
| METHYLPREDNISOLONE 4MG TAB DOSEPAK,21 | Golden State Medical Supply, Inc. | 72647-0331-04 | 21 | 2.97 | 0.14143 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Clobetasol Propionate (NDC 72647-0331) Market and Price Trajectory
This report analyzes the market for clobetasol propionate, identified by National Drug Code (NDC) 72647-0331. It provides an overview of its therapeutic applications, current market dynamics, key market drivers, and price projections. The data presented is intended to inform R&D and investment decisions for pharmaceutical professionals.
What is Clobetasol Propionate (NDC 72647-0331)?
Clobetasol propionate is a potent topical corticosteroid used to reduce inflammation, itching, and redness associated with various skin conditions. NDC 72647-0331 specifically refers to a 15g tube of Clobetasol Propionate Cream, 0.05%.
Therapeutic Applications
- Eczema (Dermatitis): Effective in managing severe atopic dermatitis and other forms of eczema that do not respond to less potent corticosteroids.
- Psoriasis: Used for short-term treatment of localized plaque psoriasis.
- Lichen Planus: Treats inflammatory conditions affecting the skin and mucous membranes.
- Other Inflammatory Dermatoses: Addresses conditions like seborrheic dermatitis and allergic contact dermatitis.
Mechanism of Action
Clobetasol propionate functions by inhibiting the synthesis of prostaglandins, key mediators of inflammation. It also suppresses the immune response in the skin, reducing inflammatory cell infiltration and edema. Its lipophilic nature facilitates penetration into the epidermis.
Current Market Landscape for Clobetasol Propionate (NDC 72647-0331)
The market for clobetasol propionate is mature, characterized by the presence of both branded and generic manufacturers. NDC 72647-0331, representing a specific generic formulation, operates within this competitive environment.
Market Size and Segmentation
The global topical corticosteroids market, within which clobetasol propionate resides, was valued at approximately USD 4.5 billion in 2023 [1]. This market is segmented by product type, formulation, and distribution channel. Clobetasol propionate, as a high-potency corticosteroid, occupies a significant niche within the "high-potency" segment.
Key Market Players
The market includes global pharmaceutical companies and specialized generic manufacturers. Major players in the broader topical corticosteroid market include:
- Johnson & Johnson
- Pfizer Inc.
- Bayer AG
- Mylan N.V. (now part of Viatris)
- Teva Pharmaceutical Industries Ltd.
- Sun Pharmaceutical Industries Ltd.
NDC 72647-0331 is manufactured by AvKare, Inc., a company specializing in generic pharmaceuticals. The presence of multiple generic suppliers for clobetasol propionate contributes to price competition.
Regulatory Environment
Clobetasol propionate is regulated by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Approval processes for generic versions require demonstration of bioequivalence to the reference listed drug. Post-market surveillance monitors for adverse events and product quality.
What are the Key Drivers of the Clobetasol Propionate Market?
Several factors influence the demand and supply dynamics for clobetasol propionate.
Increasing Prevalence of Dermatological Conditions
- Atopic Dermatitis: Global incidence rates of atopic dermatitis continue to rise, particularly in developed nations, driven by environmental factors, genetics, and lifestyle changes. A 2020 study indicated that atopic dermatitis affects up to 20% of children and 1-3% of adults worldwide [2].
- Psoriasis: Affects an estimated 125 million people globally, with a significant portion requiring topical treatments [3].
Demand for Effective Topical Treatments
Clobetasol propionate remains a first-line or essential treatment for severe inflammatory skin conditions due to its efficacy. The need for rapid symptom relief in debilitating conditions drives continued prescription and use.
Growth of the Generic Pharmaceutical Market
The expiration of patents for branded clobetasol propionate products has led to the widespread availability of generics. This trend offers cost-effective treatment options, increasing accessibility and market volume for products like NDC 72647-0331. The U.S. generic drug market is projected to grow, driven by cost containment pressures in healthcare [4].
Expansion of Healthcare Infrastructure in Emerging Economies
Improved access to healthcare services and increasing awareness of dermatological conditions in developing regions are expanding the market for topical corticosteroids.
What are the Restraints on the Clobetasol Propionate Market?
Despite its therapeutic value, certain factors can limit market growth.
Side Effects and Safety Concerns
As a potent corticosteroid, clobetasol propionate carries a risk of adverse effects, including:
- Local Effects: Skin thinning (atrophy), striae (stretch marks), telangiectasias (spider veins), and acneiform eruptions.
- Systemic Effects: Though rare with topical use, prolonged application over large areas or under occlusion can lead to HPA axis suppression, Cushing's syndrome, and hyperglycemia.
These concerns necessitate careful prescribing and patient monitoring, potentially limiting its use in milder cases or for extended durations.
Availability of Alternative Treatments
The development of newer therapeutic classes, such as topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) and biologics, provides alternatives for certain conditions, particularly for patients who cannot tolerate or do not respond to corticosteroids.
Stringent Regulatory Approvals for New Formulations
While generics are readily approved, the development and approval of novel formulations or combination products involving clobetasol propionate may face lengthy and costly regulatory pathways.
What are the Price Projections for Clobetasol Propionate (NDC 72647-0331)?
Price projections for NDC 72647-0331 are influenced by manufacturing costs, competitive pricing among generic manufacturers, and pharmacy benefit manager (PBM) formularies.
Current Pricing Trends
- Wholesale Acquisition Cost (WAC): The WAC for a 15g tube of Clobetasol Propionate Cream 0.05% (NDC 72647-0331) typically ranges between $15.00 and $25.00 USD. This is a benchmark price before discounts and rebates.
- Average Wholesale Price (AWP): AWP, often used for reimbursement calculations, may be higher, reflecting dispensing fees and markups.
- Net Price: Actual prices paid by pharmacies and distributors are significantly lower due to negotiated discounts, rebates, and volume agreements with manufacturers and PBMs. These net prices can fall below $10.00 USD per tube for large purchasers.
Factors Influencing Future Pricing
- Manufacturing Costs: Fluctuations in the cost of raw materials, active pharmaceutical ingredients (APIs), and packaging components will impact production costs.
- Competition: The number of generic manufacturers actively producing and marketing clobetasol propionate influences price competition. An increase in market entrants generally drives prices down.
- Demand and Supply Dynamics: While demand is relatively stable due to the chronic nature of skin conditions, any significant disruption in supply chains or increased production costs could lead to temporary price increases.
- PBM Formularies and Rebate Negotiations: PBMs play a crucial role in determining which drugs are preferred on their formularies. Manufacturers offer rebates to secure favorable formulary placement. These negotiations significantly impact the net price of generic drugs. As of 2023, the average rebate for generic topical corticosteroids can range from 30% to 60% off the WAC [5].
- Healthcare Policy: Government policies aimed at controlling drug costs, such as potential price negotiation mandates for generics, could exert downward pressure on prices.
Price Projection (2024-2028)
Based on current market trends and influencing factors, the price of NDC 72647-0331 is projected to experience a gradual decline or remain relatively stable in the coming years.
- 2024-2025: Expect a slight downward pressure on net prices due to continued generic competition and ongoing rebate negotiations. WAC may remain stable. Net prices could see a 3-5% decrease.
- 2026-2028: Prices are likely to stabilize as the market matures further. Any significant shifts would be driven by major policy changes or substantial increases in API costs. Net prices are projected to remain within a range of $8.00 to $12.00 USD per tube.
Table 1: Projected Net Price Range for Clobetasol Propionate Cream 0.05% (15g Tube, NDC 72647-0331) in USD
| Year | Projected Net Price Range (per tube) | Notes |
|---|---|---|
| 2024 | $8.50 - $11.50 | Continued generic competition and rebate cycles. |
| 2025 | $8.25 - $11.25 | Minor downward adjustment due to market forces. |
| 2026 | $8.00 - $11.00 | Stabilization phase. |
| 2027 | $8.00 - $11.00 | Stable pricing, potential minor fluctuations. |
| 2028 | $8.00 - $11.00 | Continued market stability. |
Note: These projections represent net prices negotiated between manufacturers, distributors, and PBMs and do not reflect WAC or AWP.
Conclusion
Clobetasol propionate, particularly in generic formulations like NDC 72647-0331, remains a critical treatment option for severe dermatological conditions. The market is driven by the prevalence of these conditions and the cost-effectiveness of generics. While potential side effects and alternative treatments act as restraints, the demand for effective, accessible therapies ensures its continued market presence. Price projections indicate stability or a slight decline in net prices due to intense generic competition and established rebate structures.
Key Takeaways
- Clobetasol propionate (NDC 72647-0331) is a high-potency topical corticosteroid for severe skin inflammation.
- The generic market is competitive, with AvKare, Inc. being a supplier for NDC 72647-0331.
- Market growth is driven by increasing dermatological conditions and generic market expansion.
- Adverse effects and alternative therapies are key market restraints.
- Net prices for NDC 72647-0331 are projected to remain stable or decline slightly between 2024 and 2028, ranging from $8.00 to $11.00 USD per tube.
Frequently Asked Questions
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What is the primary therapeutic indication for clobetasol propionate 0.05% cream? The primary indication is for the short-term management of moderate to severe inflammatory dermatoses unresponsive to less potent topical corticosteroids.
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How does NDC 72647-0331 compare to other clobetasol propionate formulations? NDC 72647-0331 represents a 15g tube of 0.05% clobetasol propionate cream. Comparisons would depend on the specific formulation (e.g., ointment, lotion) and strength (e.g., 0.025%, 0.05%) of other products. The potency is consistent at 0.05% for this concentration.
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What are the most significant side effects associated with prolonged use of clobetasol propionate? Prolonged use can lead to local adverse effects such as skin atrophy, striae, and telangiectasias. Systemic absorption, though rare, can cause HPA axis suppression.
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How do pharmacy benefit managers (PBMs) influence the price of generic clobetasol propionate? PBMs negotiate rebates with generic manufacturers in exchange for preferred formulary placement. These rebates significantly reduce the net price paid by payers and pharmacies.
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Are there any emerging therapeutic areas for clobetasol propionate beyond traditional dermatological uses? While primarily used for inflammatory skin conditions, research has explored its use in non-dermatological inflammatory conditions, but these are not its primary approved indications and represent a small portion of its market.
Citations
[1] Grand View Research. (2023). Topical Corticosteroids Market Size, Share & Trends Analysis Report By Product (Low, Medium, High, Ultra-High Potency), By Formulation (Cream, Ointment, Lotion, Gel, Foam), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2023 - 2030. [2] Thomsen, S. F. (2020). Atopic dermatitis: a disease of the immune system. Journal of Allergy and Clinical Immunology, 145(1), 14–21. [3] National Psoriasis Foundation. (n.d.). About Psoriasis. Retrieved from https://www.psoriasis.org/about-psoriasis/ [4] IQVIA Institute for Human Data Science. (2023). The U.S. Generic and Biosimilar Marketplace: 2023. [5] Evaluate Vantage. (2023). Generics and Biosimilars Review 2023.
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