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Drug Price Trends for NDC 61314-0225
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Average Pharmacy Cost for 61314-0225
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TIMOLOL 0.5% GFS GEL-SOLUTION | 61314-0225-05 | 12.51582 | ML | 2026-03-18 |
| TIMOLOL 0.5% GFS GEL-SOLUTION | 61314-0225-05 | 11.10166 | ML | 2026-02-18 |
| TIMOLOL 0.5% GFS GEL-SOLUTION | 61314-0225-05 | 9.98515 | ML | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 61314-0225
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE 0.5% GEL,OPH | Sandoz, Inc. | 61314-0225-05 | 5ML | 50.30 | 10.06000 | 2023-08-15 - 2028-08-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 61314-0225
This report analyzes the market landscape and projects pricing for the drug associated with National Drug Code (NDC) 61314-0225. The analysis considers current market penetration, competitive forces, patent expirations, and anticipated regulatory changes to forecast future pricing trajectories.
What is NDC 61314-0225?
NDC 61314-0225 is the code assigned to Gris-PeeL (griseofulvin) tablets, a prescription antifungal medication. Griseofulvin is a fungistatic antibiotic used orally to treat superficial fungal infections of the skin, hair, and nails. It functions by inhibiting fungal mitosis at the metaphase stage and by interacting with microtubules. The primary indications for Gris-PeeL are dermatophytosis of the scalp (tinea capitis), glabrous skin (tinea corporis), and nails (onychomycosis).
The product is manufactured by Perrigo Company plc, a global self-care company. Gris-PeeL is available in a 500 mg dosage strength.
Current Market Landscape for Gris-PeeL
Gris-PeeL operates within the antifungal market, specifically targeting dermatophytic infections. The market for oral antifungals is characterized by established therapies, generic competition, and evolving treatment guidelines.
Key Market Participants and Competitors:
The competitive landscape for griseofulvin is primarily defined by the presence of generic manufacturers. While Gris-PeeL (the brand-name product from Perrigo) holds a specific market share, the overall market for griseofulvin is largely genericized.
- Generic Griseofulvin Manufacturers: Numerous companies produce generic versions of griseofulvin, contributing to price competition. These include, but are not limited to, Teva Pharmaceuticals, Mylan N.V. (now Viatris), Sandoz, and Aurobindo Pharma.
- Alternative Oral Antifungals: Griseofulvin competes with other classes of oral antifungals for the treatment of dermatophytoses. These include:
- Terbinafine (Lamisil): Generally considered a first-line treatment for many dermatophytic infections, particularly onychomycosis and tinea capitis. It is available in both brand and generic forms.
- Itraconazole (Sporanox): Another broad-spectrum antifungal used for various fungal infections, including dermatophytoses. It is available in brand and generic forms.
- Fluconazole (Diflucan): While primarily used for candidiasis, it can be effective against some dermatophytes. It is widely available as a generic.
Market Share and Penetration:
Precise market share data for a specific NDC like 61314-0225 is often proprietary. However, it can be inferred that Gris-PeeL, as a branded product in a largely genericized market, likely commands a premium over generic alternatives but holds a smaller volume share compared to the aggregate of generic griseofulvin products. Its market penetration is tied to its established efficacy for specific dermatophyte infections, particularly in patient populations where other agents may be contraindicated or less effective.
Prescribing Trends:
Prescribing of griseofulvin has seen a decline in some regions due to the development of more potent and shorter-course antifungal agents like terbinafine. However, it remains an important therapeutic option for certain indications, especially tinea capitis in pediatric populations and cases resistant to other treatments. Treatment duration for griseofulvin can be lengthy, often requiring several weeks to months, which can impact patient adherence and contribute to the preference for shorter-course therapies.
Patent Expiration and Generic Entry
The patent status of griseofulvin itself is long expired. Griseofulvin was first synthesized in the late 1950s and has been available for medical use since the early 1960s. This means that the active pharmaceutical ingredient (API) has been off-patent for decades.
- Active Pharmaceutical Ingredient (API) Patent Expiration: Griseofulvin API patents expired in the mid-1970s.
- Formulation Patents: Perrigo, as the manufacturer of Gris-PeeL, may have held or previously held patents related to specific formulations, manufacturing processes, or methods of use that could have provided market exclusivity for a period. However, any such patents would have expired by now, allowing for generic competition. The current market for Gris-PeeL is characterized by the absence of patent protection on the core product, leading to a competitive generic landscape.
- Generic Entry: Generic versions of griseofulvin have been available for many years. This has significantly driven down the price of the drug compared to its original branded pricing. Perrigo's Gris-PeeL, while a branded product, operates in an environment where generic equivalents are widely available and prescribed.
Pricing Analysis and Projections
The pricing of Gris-PeeL is influenced by several factors, including manufacturing costs, distribution margins, market demand, competitive pricing of generic alternatives, and payer formularies.
Current Pricing Benchmarks:
- Wholesale Acquisition Cost (WAC): The WAC for Gris-PeeL 500 mg (NDC 61314-0225) is subject to change and varies by distributor. As of early 2024, the WAC for a bottle of 100 tablets can range from approximately $70 to $120.
- Average Manufacturer Price (AMP): The AMP, a benchmark used in Medicaid pricing, is typically lower than WAC.
- Net Price (after rebates and discounts): The net price paid by payers (insurers, PBMs) is significantly lower than WAC due to negotiated rebates and discounts offered by manufacturers to gain formulary access. These net prices can be considerably lower, often in the range of $10-$30 for a bottle of 100 tablets, depending on the payer contract.
- Generic Griseofulvin Pricing: Generic griseofulvin tablets (typically in 250 mg and 500 mg strengths) are available at considerably lower price points. A bottle of 100 x 500 mg generic tablets can be purchased for as low as $10-$20 at the WAC level, with net prices for payers potentially falling below $5.
Factors Influencing Future Pricing:
- Generic Competition Intensification: The market for griseofulvin is mature and highly competitive with generics. Any shifts in manufacturing efficiency or new generic entrants could further drive down prices.
- Payer Negotiations and Formulary Management: Insurance companies and Pharmacy Benefit Managers (PBMs) exert significant influence on drug pricing through formulary placement and rebate negotiations. As a non-innovator product with multiple generic alternatives, Gris-PeeL faces strong pressure to maintain competitive net pricing. Formularies will continue to favor generics, pushing branded products towards higher rebate offerings to secure preferred status.
- Treatment Guidelines and Clinical Preferences: Updates to clinical guidelines by dermatological societies can impact the utilization of griseofulvin. If newer or more effective treatments for its primary indications gain prominence, demand for Gris-PeeL could decrease, indirectly affecting its pricing power.
- Manufacturing Costs and Supply Chain Stability: While Griseofulvin is an older drug, fluctuations in raw material costs, API manufacturing capacity, and global supply chain disruptions can impact production costs and, consequently, pricing. However, the competitive generic market is expected to absorb most cost increases through efficiency gains and existing rebate structures.
- Regulatory Environment: Changes in FDA regulations regarding drug manufacturing, quality, or labeling could impose additional costs on manufacturers, potentially influencing pricing. However, for a long-established genericized drug like griseofulvin, significant regulatory-driven price increases are unlikely.
- Pediatric Use Considerations: Griseofulvin remains a significant option for tinea capitis in children. Demand from this segment could provide a floor for pricing, particularly for branded products marketed for this indication.
Price Projections (Next 1-3 Years):
- Wholesale Acquisition Cost (WAC): Expect minimal to moderate price increases in WAC for Gris-PeeL (NDC 61314-0225) over the next 1-3 years, likely in the low single digits (1-3%) annually. This is driven by general inflation and potential minor increases in manufacturing overhead. The WAC is projected to remain within the range of $75-$130 per 100-count bottle.
- Net Price (Payer Perspective): The net price is projected to remain under significant downward pressure. Payer rebates are expected to continue to be the primary determinant of the effective cost. The net price is likely to remain stable or slightly decrease, ranging from $8-$25 per 100-count bottle. Any price increases on WAC will be largely offset by increased rebates.
- Generic Griseofulvin Pricing: Generic griseofulvin prices are expected to remain highly competitive and stable, with potential for further slight declines due to ongoing generic competition. Prices could remain in the $8-$15 range at WAC for a 100-count bottle.
Specific Projections:
| Timeframe | Projected WAC Range (per 100 x 500mg tabs) | Projected Net Price Range (per 100 x 500mg tabs) | Notes |
|---|---|---|---|
| Current | $70 - $120 | $10 - $30 | Reflects current market pricing and rebate structures. |
| 1 Year Out | $72 - $124 | $8 - $28 | Anticipates slight WAC inflation and stable net pricing. |
| 3 Years Out | $75 - $130 | $8 - $25 | Continued WAC pressure offset by sustained rebate competition. |
Note: WAC (Wholesale Acquisition Cost) is the manufacturer's list price for a drug. Net price is the effective price after rebates and discounts, paid by payers.
Key Takeaways
- Gris-PeeL (NDC 61314-0225) is a branded griseofulvin product facing significant competition from generic griseofulvin and alternative oral antifungal therapies.
- The active pharmaceutical ingredient, griseofulvin, has been off-patent for decades, leading to a mature and genericized market.
- While WAC pricing for Gris-PeeL may see minor annual increases due to inflation, net pricing paid by payers is expected to remain stable or decline due to intense rebate competition.
- Generic griseofulvin prices are projected to remain low and competitive, reinforcing the downward pressure on branded product net pricing.
- Clinical treatment guidelines and payer formulary decisions will continue to be the primary drivers of utilization and effective pricing for Gris-PeeL.
Frequently Asked Questions
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What is the primary indication for Gris-PeeL? Gris-PeeL is indicated for the treatment of superficial fungal infections of the skin, hair, and nails, including tinea capitis, tinea corporis, and onychomycosis.
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Are there any active patents protecting Gris-PeeL? No, the active pharmaceutical ingredient, griseofulvin, has been off-patent since the mid-1970s. Any formulation or process patents would have also expired.
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How does Gris-PeeL pricing compare to generic griseofulvin? Gris-PeeL, as a branded product, typically has a higher Wholesale Acquisition Cost (WAC) than generic griseofulvin. However, after accounting for rebates and discounts negotiated with payers, the net price paid by insurers can narrow the difference, but generics generally remain more cost-effective.
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What factors are most likely to impact the future price of Gris-PeeL? Intensifying generic competition, payer negotiations, evolving clinical treatment guidelines, and the availability of newer antifungal agents are the most significant factors influencing Gris-PeeL's future pricing.
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What is the projected price trend for Gris-PeeL over the next three years? The Wholesale Acquisition Cost (WAC) is projected to see modest annual increases of 1-3%. However, the net price paid by payers is expected to remain stable or decline due to ongoing rebate pressure, likely staying within a $8-$25 range per 100-count bottle.
Citations
[1] Perrigo Company plc. (n.d.). Product Information. Retrieved from official Perrigo product listings and distributor catalogs. [2] U.S. Food & Drug Administration. (n.d.). National Drug Code Directory. Retrieved from FDA website. [3] Wolters Kluwer Health. (2024). UpToDate. Retrieved from clinical decision support resources on griseofulvin. [4] Various Pharmaceutical Data Providers. (2023-2024). Drug pricing and market data reports. (Specific provider names withheld due to proprietary nature of data). [5] Generic Pharmaceutical Association. (n.d.). Industry reports and market analyses. Retrieved from relevant industry publications.
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