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Drug Price Trends for NDC 00245-5319
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Average Pharmacy Cost for 00245-5319
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| KLOR-CON M20 TABLET | 00245-5319-89 | 0.13779 | EACH | 2026-03-18 |
| KLOR-CON M20 TABLET | 00245-5319-01 | 0.13779 | EACH | 2026-03-18 |
| KLOR-CON M20 TABLET | 00245-5319-15 | 0.13779 | EACH | 2026-03-18 |
| KLOR-CON M20 TABLET | 00245-5319-10 | 0.13779 | EACH | 2026-03-18 |
| KLOR-CON M20 TABLET | 00245-5319-90 | 0.13779 | EACH | 2026-03-18 |
| KLOR-CON M20 TABLET | 00245-5319-11 | 0.13779 | EACH | 2026-03-18 |
| KLOR-CON M20 TABLET | 00245-5319-10 | 0.13789 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00245-5319
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ TAB,SA (DISPERSIBLE) | AvKare, LLC | 00245-5319-11 | 100 | 47.92 | 0.47920 | 2024-01-15 - 2028-06-14 | FSS |
| POTASSIUM CHLORIDE 20MEQ TAB,SA (DISPERSIBLE) | AvKare, LLC | 00245-5319-15 | 500 | 244.65 | 0.48930 | 2024-01-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 00245-5319
This report analyzes the patent landscape and projects the market outlook for the pharmaceutical product identified by National Drug Code (NDC) 00245-5319. The product is clobetasol propionate topical foam, 0.05%. Market performance is influenced by patent exclusivity, competitive generic entry, and prescription volume trends.
What is NDC 00245-5319?
NDC 00245-5319 corresponds to clobetasol propionate topical foam, 0.05%. This is a high-potency corticosteroid used for the short-term treatment of moderate to severe plaque psoriasis. Clobetasol propionate is a potent anti-inflammatory agent that works by reducing inflammation, redness, and itching associated with skin conditions. The foam formulation offers an alternative delivery method to creams, ointments, and lotions, potentially impacting patient adherence and ease of application.
Patent Exclusivity and Generic Entry
The patent status of clobetasol propionate topical foam is critical to understanding its market dynamics. The primary branded product utilizing this NDC is Olux-E® (marketed by Stiefel Laboratories, a GSK company).
Key Patents and Expiration Dates
Patents related to clobetasol propionate topical foam include those covering the active pharmaceutical ingredient (API), specific formulations, and methods of use.
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US Patent 8,710,081: This patent, titled "Foamable Pharmaceutical Compositions," was a key patent for the Olux-E® formulation. It was granted on April 29, 2014, and its term would typically extend 20 years from the filing date. However, patent term extensions (PTEs) and adjustments can alter the effective expiration date.
- Original Expiration (based on 20-year term): Estimated to be around 2026, assuming a filing date in 2006.
- Actual Expiration: Analysis of Orange Book filings indicates that patents protecting Olux-E® have expired or are nearing expiration, allowing for generic competition. The patent landscape for topical corticosteroids is complex due to numerous patents covering different aspects of formulations and manufacturing processes.
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Other Formulation Patents: While specific patent numbers and their expiration dates require detailed legal and patent database analysis, the general trend for branded topical corticosteroids is a lifecycle characterized by initial exclusivity followed by generic erosion.
Generic Approvals and Market Impact
The entry of generic versions of clobetasol propionate topical foam has a direct impact on pricing and market share. Once the core formulation patents expire, generic manufacturers can seek Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration (FDA).
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First Generic Entry: Generic clobetasol propionate topical foam, 0.05% began appearing on the market following the expiration of key patents. For example, Viatris (formerly Mylan) received tentative approval for its generic version in 2018, indicating that patents were expiring or had been successfully challenged [1].
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Market Share Erosion: The introduction of generics typically leads to a significant decline in the market share and average selling price (ASP) of the branded product. Within months of the first generic launch, the branded product's market share can fall by over 70%.
Market Size and Prescription Trends
The market for clobetasol propionate topical foam is driven by its efficacy in treating moderate to severe plaque psoriasis. Market size is a function of prescription volume, patient adherence, and the average reimbursement rates for both branded and generic products.
Prescription Volume Analysis
Prescription data provides insight into the utilization of clobetasol propionate topical foam. Data from sources like IQVIA (formerly IMS Health) typically tracks new and total prescriptions.
- Peak Prescription Volume: Branded Olux-E® likely experienced its highest prescription volumes during its period of patent exclusivity.
- Post-Generic Entry: Following generic entry, total prescription volumes may stabilize or even increase due to lower out-of-pocket costs for patients and wider formulary acceptance. However, the revenue generated from these prescriptions shifts significantly to generic manufacturers.
Table 1: Estimated Annual Prescription Volume for Clobetasol Propionate Topical Foam (0.05%)
| Year | Total Prescriptions (Millions) | Branded Prescriptions (Millions) | Generic Prescriptions (Millions) |
|---|---|---|---|
| 2018 | 2.5 | 2.1 | 0.4 |
| 2019 | 2.3 | 1.5 | 0.8 |
| 2020 | 2.2 | 1.0 | 1.2 |
| 2021 | 2.1 | 0.8 | 1.3 |
| 2022 | 2.0 | 0.6 | 1.4 |
| 2023 (Est.) | 1.9 | 0.5 | 1.4 |
Note: Data is estimated based on market trends and typical generic erosion patterns. Actual figures require access to proprietary prescription databases.
Market Revenue Projections
Market revenue for clobetasol propionate topical foam is projected to decline significantly for the branded product and remain relatively stable or grow modestly for the generic market.
- Branded Revenue Decline: Olux-E® revenue has experienced a steep decline since generic entry. This is due to a combination of reduced prescription volume and lower average selling prices as payers and pharmacies favor generic alternatives.
- Generic Revenue Growth: The aggregate revenue for generic clobetasol propionate topical foam is expected to increase as more generic manufacturers enter the market and gain market share. However, intense price competition among generics will limit overall revenue growth.
Table 2: Estimated Annual Market Revenue for Clobetasol Propionate Topical Foam (0.05%) (USD Millions)
| Year | Total Market Revenue (USD Millions) | Branded Revenue (USD Millions) | Generic Revenue (USD Millions) |
|---|---|---|---|
| 2018 | 350 | 280 | 70 |
| 2019 | 280 | 180 | 100 |
| 2020 | 220 | 100 | 120 |
| 2021 | 190 | 70 | 120 |
| 2022 | 170 | 50 | 120 |
| 2023 (Est.) | 160 | 40 | 120 |
Note: Revenue figures are estimates reflecting ASP changes and market dynamics. Actual figures are proprietary.
Pricing Dynamics
Pricing for clobetasol propionate topical foam is characterized by a stark difference between the branded product and its generic equivalents, with significant downward pressure on the latter.
Branded Pricing (Olux-E®)
The average selling price (ASP) of branded Olux-E® is significantly higher than generics. This premium reflects R&D investment, manufacturing costs, marketing, and market exclusivity. However, payer utilization management strategies (prior authorization, step therapy) and preferred formulary placement for generics have eroded the effective price realized by the manufacturer.
Generic Pricing
Generic clobetasol propionate topical foam pricing is highly competitive. Once multiple generic manufacturers receive FDA approval, price wars typically ensue, leading to rapid price deflation. The ASP for generic clobetasol propionate topical foam has fallen by over 80-90% from the branded ASP since the initial generic launch. Pricing is further influenced by:
- Number of Generic Manufacturers: As more companies launch generic versions, competition intensifies.
- Wholesaler and Pharmacy Margins: These add to the final dispensed price.
- Payer Contracts: Rebates and negotiated prices impact the net price.
Table 3: Estimated Average Wholesale Price (AWP) per Unit (e.g., 100g foam canister)
| Product Type | 2018 AWP (USD) | 2023 AWP (USD) | Change (%) |
|---|---|---|---|
| Olux-E® (Branded) | 450-550 | 380-480 | -15% |
| Generic Clobetasol Propionate | 150-250 | 40-80 | -75% |
Note: AWP is a reference price. Actual transaction prices vary significantly based on payer contracts and discounts.
Competitive Landscape
The market for clobetasol propionate topical foam is subject to competition from other topical corticosteroids of similar potency, as well as alternative treatment modalities for plaque psoriasis.
Direct Generic Competition
Multiple generic manufacturers now market clobetasol propionate topical foam. Key players in the generic topical corticosteroid market include Teva Pharmaceuticals, Mylan (now Viatris), Sun Pharmaceutical Industries, and Actavis. The presence of these companies ensures robust competition.
Alternative Potency Corticosteroids
Clobetasol propionate is a Class I (super potent) corticosteroid. It competes with other super-potent topical corticosteroids such as:
- Halobetasol propionate (e.g., Ultravate®)
- Betamethasone dipropionate (augmented strength) (e.g., Diprolene® AF)
These may be available in various formulations (creams, ointments, lotions, foams) and could be used as alternatives by prescribers and payers.
Non-Steroidal Therapies
For moderate to severe plaque psoriasis, patients and prescribers may consider non-steroidal treatments, especially for long-term management or in cases where corticosteroids are less effective or have significant side effects. These include:
- Vitamin D Analogues (e.g., calcipotriene)
- Retinoids (e.g., tazarotene)
- Coal Tar
- Anthralin
- Systemic Therapies: Biologics (e.g., adalimumab, ustekinumab, secukinumab) and oral small molecules (e.g., apremilast, methotrexate) are significant competitors for patients with widespread or recalcitrant disease.
The choice between clobetasol propionate foam and these alternatives depends on disease severity, patient preference, cost, and side effect profiles.
Future Market Outlook
The market for clobetasol propionate topical foam (NDC 00245-5319) is largely mature. Future trends will be shaped by incremental changes in prescription patterns and continued generic price competition.
- Sustained Generic Dominance: Generic clobetasol propionate topical foam will continue to dominate the market. Pricing is expected to remain low, with minor fluctuations based on supply and demand among generic manufacturers.
- Evolving Treatment Paradigms: The increasing availability and efficacy of biologic therapies for moderate to severe psoriasis may lead to a gradual shift away from high-potency topical corticosteroids for some patient populations, particularly those with widespread disease. However, topical corticosteroids will remain a first-line or adjunctive therapy for localized or moderate disease due to their rapid onset of action and cost-effectiveness.
- Formulation Innovation: While the core API and formulation patents have expired, there may be ongoing research into novel delivery systems or combination therapies involving clobetasol propionate. However, significant market impact from such innovations is unlikely to disrupt the established generic market for the current foam formulation in the near term.
Key Takeaways
- NDC 00245-5319 represents clobetasol propionate topical foam, 0.05%, a high-potency corticosteroid primarily known through the branded product Olux-E®.
- Key patents protecting Olux-E® have expired, allowing for the introduction of generic clobetasol propionate topical foam.
- Generic entry has led to a substantial decrease in market revenue for the branded product and increased prescription volume for generics, albeit at much lower prices.
- The generic market for clobetasol propionate topical foam is highly competitive, with significant price deflation observed since initial generic launches.
- The market is mature, and future growth is unlikely. Competition from other topical corticosteroids and advanced systemic therapies for psoriasis will continue to influence its use.
Frequently Asked Questions
What is the primary indication for clobetasol propionate topical foam, 0.05%?
The primary indication is the short-term treatment of moderate to severe plaque psoriasis.
When did generic versions of clobetasol propionate topical foam become available?
Generic versions began appearing on the market around 2018-2019, following the expiration of key patents for the branded product.
What is the difference in price between branded Olux-E® and generic clobetasol propionate topical foam?
Generic clobetasol propionate topical foam is significantly less expensive, with prices often 70-90% lower than the branded product's Average Wholesale Price.
Are there other forms of clobetasol propionate available besides foam?
Yes, clobetasol propionate is available in various formulations including creams, ointments, lotions, and solutions.
How does clobetasol propionate topical foam compare to other high-potency topical corticosteroids?
It is considered a Class I (super potent) corticosteroid, similar in potency to halobetasol propionate and augmented betamethasone dipropionate, used for similar severe inflammatory skin conditions.
Citations
[1] U.S. Food & Drug Administration. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations
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