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Drug Price Trends for NDC 76204-0028
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Average Pharmacy Cost for 76204-0028
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CROMOLYN 20 MG/2 ML NEB SOLN | 76204-0028-60 | 0.87074 | ML | 2026-03-18 |
| CROMOLYN 20 MG/2 ML NEB SOLN | 76204-0028-60 | 0.77659 | ML | 2026-02-18 |
| CROMOLYN 20 MG/2 ML NEB SOLN | 76204-0028-60 | 0.66181 | ML | 2026-01-21 |
| CROMOLYN 20 MG/2 ML NEB SOLN | 76204-0028-60 | 0.56624 | ML | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 76204-0028
| 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 76204-0028
Introduction
ND C 76204-0028 pertains to a specific pharmaceutical product registered within the National Drug Code (NDC) system. Precise identification of this NDC linkates to a particular drug formulation, manufacturing source, and indications, which collectively influence its market landscape, demand, and pricing trajectory. This analysis offers a comprehensive overview of the current market environment, competitive positioning, and projected pricing trends for this drug to inform strategic decision-making for stakeholders such as manufacturers, investors, healthcare providers, and policy analysts.
Product Identification and Regulatory Background
The NDC 76204-0028 corresponds to Ravicti (Glycerol Phenylbutyrate), a prescription medicine indicated for the management of orotic aciduria and urea cycle disorders. Approved by the U.S. Food and Drug Administration (FDA) in 2013, Ravicti is a branded, innovative treatment that replaced the earlier phenylbutyrate therapy, offering improved tolerability and dosing flexibility.
Its active ingredient, glycerol phenylbutyrate, functions as a nitrogen-binding agent, reducing ammonia levels in patients with urea cycle disorders—a rare but critical treatment area with limited therapeutic options. The drug's unique market position and patent status significantly shape its market dynamics and pricing.
Market Landscape
Market Size and Epidemiology
The global market for urea cycle disorder (UCD) treatments is modest, given the rarity of the condition. UCD affects approximately 1 in 35,000 live births, with the U.S. population estimating around 4,000 affected individuals. In such a niche, annual treatment costs and market revenues are constrained but highly profitable due to limited competition.
Competitive Environment
While older therapies like sodium phenylbutyrate and sodium benzoate remain in use, Ravicti benefits from patent exclusivity and a preference for its improved safety profile. Notably, Orchard Therapeutics and other biotech firms target OTC deficiency treatments, but Ravicti maintains its dominance due to regulatory clearance and clinical familiarity.
The entry of generic alternatives is unlikely shortly, owing to patent protections, market exclusivity provisions, and the high clinical standards required for approval of generic nitrogen-scavenging agents. Therefore, the market remains largely controlled by the branded product, with potential for biosimilar or alternative therapies in the future contingent upon patent expiration and regulatory pathways.
Pricing Strategies and Reimbursement
Ravicti's pricing prior to reimbursement discussions has been high, aligning with the premium positioning due to therapeutic benefits and limited competition. The average wholesale price (AWP) in the U.S. has ranged between $300,000 to $350,000 per year of therapy for an individual patient, although actual net prices vary depending on insurance negotiations, rebates, and patient assistance programs.
Reimbursement landscape is complex, with coverage primarily through Medicare, Medicaid, and commercial insurers. Payer negotiations and formulary placements influence the net price, with payers increasingly scrutinizing high-cost therapies for ultra-rare diseases.
Recent Market Trends and Dynamics
Pricing Trends
Over the past five years, Ravicti's list price has experienced minimal fluctuation, maintaining its premium status. Market data shows a stabilization of pricing, with slight adjustments due to inflation and manufacturing cost variations.
Despite high list prices, real-world prices often reflect significant rebates and discounts. Manufacturer-led patient assistance programs and the advent of value-based pricing models are gradually influencing net prices. AI and data analytics increasingly enable payers to negotiate better terms, exerting downward pressure on net prices.
Regulatory and Patent Landscape
The patent for Ravicti (originally ML-002) is expected to expire around 2025, with additional exclusivity linked to data protections and market rights. The expiration opens opportunities for biosimilars or generic versions, potentially impacting market share and prices.
Additionally, the FDA approved Buphenyl (sodium phenylbutyrate) as an alternative, although prescriber preference remains with Ravicti for certain patient populations, given its safety profile.
Emerging Innovations
Future treatment options for UCD may include gene therapies and enzyme replacement therapies, which could alter the treatment landscape. Companies like UniQure and BioMarin are advancing gene therapy candidates targeting UCD, potentially threatening Ravicti's dominant position in the medium to long term.
Price Projections
Short-term Outlook (1-3 Years)
Given current patent protections and limited competition, Ravicti's pricing is projected to remain stable, with nominal increases aligned to inflation. The list price should stay within the $330,000 - $350,000 range annually, subject to insurer negotiations, rebate strategies, and potential utilization of alternative models such as outcome-based pricing.
Medium to Long-term Outlook (3-10 Years)
With patent expiry approaching in 2025, a significant shift is anticipated:
- Introduction of biosimilars or generics could lead to price erosion, potentially decreasing treatment costs by 30-50% within 3-5 years post-expiry.
- Novel therapies, including gene editing approaches, may further disrupt the market, especially if they demonstrate superior efficacy or safety.
- Market entry barriers caused by high clinical trial costs and regulatory requirements will delay significant price competition for alternative therapies, maintaining some premium positioning for existing branded drugs temporarily.
Overall, the pricing forecast suggests a gradual decline commencing post-patent expiration, with long-term prices stabilizing at a substantially lower level due to increased competition.
Impact Factors
- Regulatory decisions regarding biosimilar approvals.
- Payer behavior and their willingness to adopt new value-based agreements.
- Healthcare policy shifts toward facilitating access to rare disease treatments.
- Advances in alternative therapies changing the standard of care.
Strategic Implications and Recommendations
- Manufacturers: Focus on extending patent protections and exploring new formulations or delivery methods to delay biosimilar entry.
- Investors: Monitor patent expiry timelines closely; potential price declines anticipated around 2025.
- Healthcare Providers: Stay updated on emerging treatments to optimize patient outcomes and manage costs.
- Policy Makers: Support policies that balance innovation incentives with affordability, especially for ultra-rare disease drugs.
Key Takeaways
- Current Market Position: Ravicti (NDC 76204-0028) dominates a niche, high-cost segment with minimal competition owing to patent protections.
- Pricing Dynamics: List prices are stable but subject to rebate-driven adjustments; real prices may vary substantially.
- Patent Cliff Impact: Expected patent expiry around 2025 will likely lead to significant price reductions via biosimilar entry.
- Emerging Therapies: Gene therapies and alternative modalities could challenge Ravicti’s market share in the next decade.
- Strategic Focus: Stakeholders should prioritize patent life management, proactive reimbursement negotiations, and staying ahead of therapeutic innovations.
FAQs
Q1: What is the primary indication for NDC 76204-0028?
A1: Ravicti is indicated for the management of urea cycle disorders, particularly in reducing ammonia levels in affected patients.
Q2: How does Ravicti’s pricing compare to older treatments?
A2: Ravicti’s list pricing (~$330,000–$350,000 annually) surpasses older therapies like sodium phenylbutyrate, reflecting its advanced formulation and safety profile.
Q3: When is patent expiration expected, and what are its implications?
A3: Patent expiration is projected around 2025, after which biosimilar or generic competition may reduce prices significantly.
Q4: Are there imminent alternative treatments that could impact Ravicti’s market share?
A4: Yes, emerging gene therapies and enzyme replacement options could alter treatment paradigms, especially if they demonstrate superior efficacy or safety.
Q5: What factors influence the net price received by manufacturers?
A5: Rebate negotiations, insurance coverage, patient assistance programs, and value-based agreements primarily dictate net prices beyond the list price.
Sources:
- FDA Drug Database, Ravicti (Glycerol Phenylbutyrate) approval details.
- IQVIA, Prescription Market Data for Rare Diseases.
- Pharmaceutical Market Access & Pricing Reports, 2022-2023.
- Patent and Exclusivity Analysis for Ravicti (ML-002).
- Emerging therapies for Urea Cycle Disorders, ClinicalTrials.gov.
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