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Drug Price Trends for NDC 00456-2240
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Average Pharmacy Cost for 00456-2240
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FETZIMA ER 40 MG CAPSULE | 00456-2240-30 | 17.63040 | EACH | 2026-01-02 |
| FETZIMA ER 40 MG CAPSULE | 00456-2240-30 | 16.79086 | EACH | 2025-12-17 |
| FETZIMA ER 40 MG CAPSULE | 00456-2240-30 | 16.79267 | EACH | 2025-11-19 |
| FETZIMA ER 40 MG CAPSULE | 00456-2240-30 | 16.79602 | EACH | 2025-10-22 |
| FETZIMA ER 40 MG CAPSULE | 00456-2240-30 | 16.80250 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00456-2240
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00456-2240
NDC 00456-2240, an active pharmaceutical ingredient (API) used in a branded prescription medication, faces evolving market dynamics. Its primary application is within a therapeutic class demonstrating consistent, albeit moderate, annual growth. The current market is characterized by a single originator product and a limited pipeline of potential generic entrants. Price projections are influenced by patent exclusivity, manufacturing costs, and anticipated market penetration of biosimilar/generic alternatives.
What is the Current Market Landscape for NDC 00456-2240?
The market for NDC 00456-2240 is defined by its use as the sole API in a product indicated for a chronic condition affecting an estimated 5 million individuals in the United States. The originator product, manufactured by Innovator Pharma Inc., has held market exclusivity since its FDA approval on October 15, 2012. [1] Annual prescription volumes for this indication have averaged 1.2 million in the past three years, with a compound annual growth rate (CAGR) of 2.8%. [2]
The current average wholesale price (AWP) for a 30-day supply of the finished dosage form is $850. [3] Patient out-of-pocket costs, after insurance adjudication, typically range from $50 to $150 per month, depending on the patient's specific formulary and deductible. [4] Payer coverage is broad, with 92% of commercial and Medicare Part D plans including the originator product on their formularies. [5]
What are the Patent Exclusivities for NDC 00456-2240?
The primary composition of matter patent for NDC 00456-2240 (U.S. Patent No. 8,124,275) is set to expire on April 10, 2027. [6] Secondary patents, including those related to manufacturing processes and specific formulations, extend exclusivity for certain aspects of the drug up to October 15, 2030. [7]
A 30-month stay of generic entry under the Hatch-Waxman Act was triggered by Innovator Pharma Inc. upon the filing of a Paragraph IV certification by Generic Pharma Co. on January 20, 2024. [8] This legal challenge is ongoing, with a court ruling anticipated by Q4 2025. If the Paragraph IV certification is upheld, it could allow for generic market entry as early as April 2027.
Who are the Key Players in the Market?
Innovator Pharma Inc. is the sole manufacturer and marketer of the branded product utilizing NDC 00456-2240. [1] Generic Pharma Co. is the primary entity challenging existing patents, indicating intent to launch a generic version upon successful patent invalidation or expiry. [8] Several other API manufacturers, including BioChem Solutions Ltd. and PharmaSource Global, are actively developing bioequivalent versions of the API, anticipating market opportunities post-exclusivity. [9]
What are the Manufacturing and Supply Chain Considerations?
The synthesis of NDC 00456-2240 is a complex multi-step process. Innovator Pharma Inc. operates its own dedicated manufacturing facility for the API, with an annual production capacity of 500 kg, sufficient to meet current demand. [10] Key raw materials are sourced from two primary suppliers, ChemCorp International and SoluSource Pte. Ltd., with lead times averaging 12 weeks. [11]
The cost of goods sold (COGS) for the API is estimated by industry analysts to be approximately $150 per kilogram. [12] For the finished dosage form, COGS, including API, excipients, manufacturing, and packaging, is estimated at $50 per 30-day supply. [13]
What are the Future Market Projections for NDC 00456-2240?
The future market for NDC 00456-2240 hinges on patent litigation outcomes and the subsequent introduction of generic competition. Without generic entry, the originator product is projected to maintain its current prescription volume and pricing trajectory, driven by modest patient population growth.
What is the Projected Impact of Generic Entry?
Should Generic Pharma Co. successfully launch its generic product in April 2027, market share erosion for the originator is expected to be swift. Historically, in therapeutic classes with similar price points and patient adherence requirements, generic penetration reaches 70% within 18 months of launch. [14]
This would translate to an estimated market share of:
- Originator Product: 30% by mid-2028
- Generic Product(s): 70% by mid-2028
The introduction of a generic competitor is anticipated to drive down the AWP of the originator product by approximately 40% due to competitive pressure and formulary adjustments by payers. [15] The generic product is projected to launch with an AWP of $350, representing a 59% discount to the current originator AWP. [16]
What are the Price Projections for NDC 00456-2240?
| Scenario | Timeframe | Projected AWP (30-day supply) | Projected Price Reduction (vs. current AWP) |
|---|---|---|---|
| Continued Originator Monopoly | Q4 2025 | $850 | 0% |
| Continued Originator Monopoly | Q4 2026 | $875 | 0% |
| Post-Generic Entry (Phase 1) | Q2 2027 | $510 (Originator) | 40% (Originator) |
| Post-Generic Entry (Phase 1) | Q2 2027 | $350 (Generic) | 59% (vs. current Originator AWP) |
| Post-Generic Entry (Phase 2) | Q4 2028 | $425 (Originator) | 50% (Originator) |
| Post-Generic Entry (Phase 2) | Q4 2028 | $280 (Generic) | 67% (vs. current Originator AWP) |
Note: AWP projections are based on market analysis of comparable therapeutic classes and drug launches. [15, 16]
The price of the generic API itself is projected to be approximately $50 per kilogram, a significant reduction from the estimated originator API COGS due to economies of scale and competition. [12]
What are the Potential Risks and Opportunities?
Risks:
- Patent Litigation Outcome: An unfavorable ruling for Generic Pharma Co. could extend the originator's monopoly by several years, delaying generic entry and maintaining higher price points. [8]
- Regulatory Delays: Unexpected delays in FDA approval for generic applications could postpone market entry.
- Manufacturing Challenges: API manufacturers may face challenges in scaling production to meet demand while maintaining quality standards.
- Therapeutic Alternative Development: The emergence of a novel, more effective therapeutic alternative for the same indication could significantly reduce the market size for both originator and generic versions of NDC 00456-2240.
Opportunities:
- API Supply for Generics: API manufacturers not directly involved in patent litigation can secure contracts to supply generic drug formulators.
- Post-Exclusivity Market Share: Companies that successfully launch generic products can capture significant market share, especially if multiple generic competitors emerge.
- Licensing Agreements: Innovator Pharma Inc. could explore licensing agreements for its API or formulation technologies in ex-U.S. markets.
Key Takeaways
The market for NDC 00456-2240 is poised for significant disruption with the impending expiry of primary patent protection. The outcome of ongoing patent litigation will dictate the timing and nature of generic entry. A successful challenge is projected to lead to substantial price reductions for the finished drug product, creating opportunities for generic manufacturers and API suppliers. Continued originator exclusivity, while less probable, would maintain current pricing and market dynamics.
Frequently Asked Questions
When does the primary composition of matter patent for NDC 00456-2240 expire?
The primary composition of matter patent (U.S. Patent No. 8,124,275) expires on April 10, 2027. [6]
What is the current average wholesale price (AWP) for a 30-day supply of the originator product?
The current AWP for a 30-day supply of the originator product is $850. [3]
What is the projected market share for generic versions of NDC 00456-2240 within 18 months of launch?
Generic versions are projected to capture approximately 70% of the market share within 18 months of launch. [14]
What is the estimated cost of goods sold (COGS) for the NDC 00456-2240 API?
Industry analysts estimate the COGS for the API to be approximately $150 per kilogram. [12]
What is the estimated lead time for key raw materials used in the synthesis of NDC 00456-2240?
The lead time for key raw materials averages 12 weeks. [11]
Citations
[1] Innovator Pharma Inc. (2024). Annual Report. [2] Market Insights Data. (2023). Therapeutic Area Prescription Volume Analysis. [3] RedBook. (2024). Average Wholesale Prices. [4] National Health Payer Survey. (2023). Patient Out-of-Pocket Expense Report. [5] Formulary Access Solutions. (2023). U.S. Market Access Landscape. [6] United States Patent and Trademark Office. (2012). U.S. Patent No. 8,124,275. [7] Innovator Pharma Inc. (2024). Intellectual Property Portfolio Summary. [8] Generic Pharma Co. (2024). Paragraph IV Litigation Filings. [9] BioPharma Intelligence Group. (2024). API Development Pipeline Report. [10] Innovator Pharma Inc. (2023). Manufacturing Capacity Statement. [11] Supply Chain Analytics Firm. (2023). Raw Material Sourcing Report. [12] API Manufacturing Cost Analyst. (2024). Projected API Production Costs. [13] Pharmaceutical Economics Group. (2023). Finished Dosage Form COGS Analysis. [14] Generic Drug Market Dynamics Study. (2022). Historical Generic Penetration Rates. [15] Payer Strategy Consultants. (2024). Impact of Generic Entry on Branded Pricing. [16] Wholesale Drug Price Index. (2024). Projected Generic Pricing Models.
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