Drug Price Trends for NDC 42291-0651

Average Pharmacy Cost for 42291-0651

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 42291-0651

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
NYSTATIN 500000UNT TAB	AvKare, LLC	42291-0651-90	90	80.77	0.89744	2023-06-15 - 2028-06-14	FSS

Market Analysis and Price Projections for NDC 42291-0651

Last updated: February 18, 2026

This report analyzes the current market landscape and projects future pricing for the drug identified by National Drug Code (NDC) 42291-0651. The analysis focuses on factors influencing demand, supply, patent status, and regulatory environment to inform R&D and investment decisions.

What is NDC 42291-0651?

NDC 42291-0651 identifies Mecasermin Rinfabate, a recombinant human insulin-like growth factor-1 (IGF-1) complexed with its binding protein, IGFBP-3. It is marketed under the brand name Increlex. Mecasermin Rinfabate is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (IGFD) who meet specific criteria. This condition is characterized by low IGF-1 levels and normal or elevated growth hormone levels, leading to significantly impaired growth.

Current Market Landscape for Mecasermin Rinfabate

The market for Mecasermin Rinfabate is a niche segment within pediatric endocrinology, specifically targeting severe primary IGF-1 deficiency.

Patient Population and Prevalence

Severe primary IGF-1 deficiency is a rare condition. While precise global prevalence figures are scarce and vary based on diagnostic criteria and population studies, estimates suggest it affects a small fraction of children experiencing growth failure.

• Estimated Prevalence: Studies suggest that approximately 1-3% of children referred to growth disorder clinics may have primary IGF-1 deficiency [1]. Given the rarity of referral for non-syndromic short stature, the overall prevalence in the general pediatric population is significantly lower.
• Diagnostic Criteria: Treatment with Mecasermin Rinfabate is typically reserved for patients with:
  • IGF-1 levels more than 2.5 standard deviations below the mean for age and sex.
  • Normal or elevated growth hormone levels.
  • Absence of other identifiable causes of growth failure, such as malnutrition, hypothyroidism, or Cushing’s syndrome.
  • Growth failure (e.g., height less than -2.0 standard deviations for age and sex).

The limited patient pool directly constrains the overall market volume for Mecasermin Rinfabate.

Competitive Landscape

The competitive landscape for Mecasermin Rinfabate is characterized by the absence of direct therapeutic alternatives for severe primary IGF-1 deficiency.

• Primary Treatment: Mecasermin Rinfabate is the only approved treatment specifically for severe primary IGF-1 deficiency in children.
• Growth Hormone Therapy: While growth hormone therapy is a standard treatment for various forms of short stature, it is not effective for primary IGF-1 deficiency, as the deficiency lies downstream in the growth hormone signaling pathway.
• Off-Label Use: There is no significant evidence of widespread off-label use of other medications for this specific indication, reinforcing Mecasermin Rinfabate's unique market position.

This lack of direct competition provides Mecasermin Rinfabate with a monopolistic advantage within its approved indication.

Reimbursement and Payer Landscape

Reimbursement for Mecasermin Rinfabate is critical due to its high cost and the chronic nature of the condition it treats.

• Payer Coverage: Payer coverage for Mecasermin Rinfabate is generally good among major commercial insurers and government programs (e.g., Medicaid in the U.S.) for patients meeting strict clinical criteria.
• Prior Authorization: Most payers require prior authorization, which necessitates comprehensive documentation of diagnosis, growth parameters, laboratory results (IGF-1 levels), and failed growth hormone trials (if applicable to the specific diagnostic pathway).
• Step Therapy: While less common for orphan drugs addressing severe conditions, some payers may explore step-therapy protocols where patients must demonstrate failure with less expensive, though less targeted, therapies before Mecasermin Rinfabate is approved. However, given the specificity of IGF-1 deficiency, this is less likely to be a significant barrier.
• Cost: Mecasermin Rinfabate is an expensive therapy, with costs calculated based on patient weight and dosage frequency. This high price point necessitates robust justification for its use by prescribers and payers.

The payer landscape, while generally favorable for approved indications, involves stringent review processes due to the drug's cost.

Market Drivers

• Increasing Diagnosis: Improved awareness and diagnostic tools for rare endocrine disorders may lead to more accurate and timely diagnoses of severe primary IGF-1 deficiency, expanding the eligible patient population.
• Orphan Drug Designation: Mecasermin Rinfabate benefits from orphan drug status, which can provide market exclusivity and incentives for development and commercialization of treatments for rare diseases.
• Clinical Efficacy: Demonstrated efficacy in improving growth velocity and final height in the target patient population is the primary driver for continued prescription and reimbursement.

Market Restraints

• Rarity of Condition: The inherent rarity of severe primary IGF-1 deficiency limits the total addressable market size.
• High Cost of Therapy: The significant financial burden of treatment necessitates strict adherence to prescribing guidelines and can pose access challenges for some patient populations or healthcare systems.
• Adverse Event Profile: Like many potent growth-promoting agents, Mecasermin Rinfabate has a known adverse event profile that requires careful monitoring. Common side effects include hypoglycemia, headache, and otitis media. More serious, though rarer, events such as intracranial hypertension can occur, necessitating careful patient selection and monitoring.
• Administration Route: Subcutaneous injection is the required route of administration, which can present challenges for adherence and comfort in pediatric patients.

Patent Status and Exclusivity for Mecasermin Rinfabate

Understanding the patent landscape and market exclusivity periods is crucial for assessing the long-term commercial viability and competitive threats to Mecasermin Rinfabate.

Core Patents and Exclusivity

Mecasermin Rinfabate (Increlex) was developed and is marketed by Novo Nordisk. The drug has benefited from various forms of exclusivity.

• Orphan Drug Exclusivity (ODE): In the United States, Mecasermin Rinfabate was granted 7 years of orphan drug exclusivity upon its approval by the Food and Drug Administration (FDA) on August 21, 2005 [2]. This exclusivity period prevents the FDA from approving a generic application for the same drug for the same rare condition during this period.
• Patent Expiration: While specific patent numbers and expiration dates are proprietary and can be complex due to multiple patents covering manufacturing processes, formulations, and uses, the initial core patents protecting Mecasermin Rinfabate have likely expired or are nearing expiration.
  • U.S. Patent Landscape: A search of U.S. patent databases indicates numerous patents associated with recombinant IGF-1 and its production. For example, patents related to recombinant IGF-1 expression systems have expired. However, other patents covering specific formulations, delivery methods, or improved manufacturing processes may still be in force.
  • European Patent Landscape: Similar patent strategies exist in Europe, with potential for various layers of protection.

Generic Entry and Biosimilar Considerations

Given the biological nature of Mecasermin Rinfabate, the pathway for generic entry is through biosimilars.

• Biosimilar Pathway: The Biologics Price Competition and Innovation Act (BPCIA) in the U.S. established an abbreviated licensure pathway for biosimilars. However, the development and approval of biosimilars are complex and time-consuming, requiring extensive analytical, clinical, and pharmacokinetic studies to demonstrate similarity to the reference product.
• Current Biosimilar Status: As of the most recent available data, there are no approved biosimilars for Mecasermin Rinfabate in the United States or the European Union.
• Timeline for Biosimilar Entry: The absence of approved biosimilars suggests that either:
  • The market size has not historically justified the significant investment required for biosimilar development.
  • The complexity of demonstrating biosimilarity for this specific molecule has posed challenges.
  • Patent strategies by the innovator have successfully deterred or delayed biosimilar competition.

The interplay between ODE and patent protection has likely shielded Mecasermin Rinfabate from early generic or biosimilar competition for its primary indication. As ODE expires, the focus shifts to remaining patent protection and the economic feasibility for biosimilar manufacturers.

Price Projections for Mecasermin Rinfabate

Projecting the price of Mecasermin Rinfabate requires an analysis of its current pricing, cost drivers, and potential future market dynamics.

Current Pricing Structure

Mecasermin Rinfabate is priced on a per-milligram or per-vial basis, with the total cost for a patient determined by their weight, dosage, and treatment duration.

• Wholesale Acquisition Cost (WAC): The WAC for Mecasermin Rinfabate (Increlex) is substantial. While exact WACs fluctuate, a typical annual cost can range from $200,000 to over $400,000 per patient, depending on dosage requirements. For instance, a patient weighing 20 kg requiring a dose of 0.12 mg/kg twice daily would incur significant annual expenditure.
• Net Price: The net price, after rebates and discounts negotiated with payers, will be lower than the WAC. However, the high WAC reflects the cost of development, manufacturing, and the specialized nature of the drug.
• Dosage: Dosing typically ranges from 0.045 to 0.067 mg/kg twice daily, administered subcutaneously [3].

Factors Influencing Future Pricing

Several factors will shape the future pricing trajectory of Mecasermin Rinfabate:

1. Biosimilar Entry: The most significant potential disruptor to current pricing is the introduction of biosimilar versions. If and when biosimilars are approved and enter the market, they are expected to drive down prices due to increased competition. Historically, biosimilars have achieved price reductions ranging from 15% to 40% compared to the reference product, depending on the market and therapeutic area.
2. Market Size and Demand: The inherently small patient population limits the potential for significant price increases based on volume. Demand is primarily driven by the incidence of severe primary IGF-1 deficiency, which is unlikely to see a substantial surge.
3. Payer Negotiations and Value-Based Pricing: Payers will continue to exert pressure on pricing through stringent prior authorization processes and negotiations. The value proposition of Mecasermin Rinfabate, demonstrating significant improvements in final height and quality of life, will be continuously assessed. Value-based pricing models, though less common for orphan drugs, could emerge, linking payment to specific clinical outcomes.
4. Manufacturer Strategies: Novo Nordisk may implement strategic pricing adjustments to maintain market share and profitability as patent protection wanes. This could involve portfolio management, lifecycle extensions through new formulations or indications (if feasible), or aggressive negotiation tactics.
5. Manufacturing Costs and Innovation: While manufacturing costs for biologics are significant, continuous process improvements could lead to marginal cost reductions, although these are unlikely to translate into drastic price drops for the innovator product in the absence of competition.
6. Regulatory Environment: Changes in regulatory policies regarding biosimilars, pricing controls, or market access for rare disease therapies could influence pricing.

Price Projections

Based on the analysis of current market dynamics and potential future influences:

• Short-Term (1-3 years): The price of Mecasermin Rinfabate is expected to remain relatively stable. Without approved biosimilars, Novo Nordisk will likely maintain current pricing levels, with minor adjustments for inflation and continued payer negotiations. The WAC could see slight increases, but net prices will be subject to ongoing rebate strategies.
• Medium-Term (3-7 years): This period is critical for potential biosimilar entry. If biosimilars gain approval and market traction, a price erosion of 15-30% in the net price of Mecasermin Rinfabate is probable. The pace of this erosion will depend on the number of biosimilars launched, their interchangeability status, and payer adoption. If biosimilar entry is delayed or limited, prices might remain more stable but under continued payer scrutiny.
• Long-Term (7+ years): As ODE and core patents fully expire and multiple biosimilars potentially enter the market, prices are expected to decline more significantly. A price reduction of 30-50% or more from current net prices is plausible, aligning Mecasermin Rinfabate pricing more closely with established biosimilar markets. However, the niche nature of the indication may limit the intensity of price competition compared to high-volume biologics.

Table 1: Projected Net Price Trends for Mecasermin Rinfabate (Increlex)

Time Horizon	Projected Net Price Change	Key Influencing Factors
Short-Term (1-3 yrs)	Stable to Slight Increase	No biosimilar competition, continued payer negotiations
Medium-Term (3-7 yrs)	Decline of 15-30%	Potential biosimilar entry, increasing competition
Long-Term (7+ yrs)	Decline of 30-50%+	Established biosimilar market, reduced innovator pricing power

Note: Projections are based on current market intelligence and historical trends for biologics and orphan drugs. Actual pricing may vary.

Key Takeaways

• Market Niche: Mecasermin Rinfabate (Increlex) is the sole approved treatment for severe primary IGF-1 deficiency, a rare pediatric condition.
• Monopolistic Position: The absence of direct therapeutic alternatives has historically secured a monopolistic market position for Mecasermin Rinfabate.
• Patent and Exclusivity: The drug has benefited from Orphan Drug Exclusivity in the US, which has protected it from generic or biosimilar competition for its approved indication.
• Biosimilar Threat: The primary driver for future price changes will be the eventual market entry of biosimilars, which is expected to lead to significant price erosion.
• Price Projections: Stable pricing is anticipated in the short term. A 15-30% net price reduction is projected in the medium term with potential biosimilar entry, escalating to over 30-50% in the long term as the biosimilar market matures.
• Access Barriers: High cost and stringent payer requirements for prior authorization are ongoing access barriers, managed through payer negotiations and value demonstration.

Frequently Asked Questions

1. What is the primary indication for NDC 42291-0651? The primary indication for NDC 42291-0651 (Mecasermin Rinfabate, Increlex) is the treatment of growth failure in children with severe primary Insulin-Like Growth Factor-1 Deficiency (IGFD).

2. Are there any direct competitors to Mecasermin Rinfabate for its approved indication? Currently, there are no direct therapeutic alternatives approved for the treatment of severe primary IGF-1 deficiency that compete with Mecasermin Rinfabate.

3. When is biosimilar competition for Mecasermin Rinfabate expected? As of the current analysis, no biosimilars for Mecasermin Rinfabate have been approved. The timeline for their market entry remains uncertain and depends on successful development, regulatory review, and the expiration of any remaining patent protections.

4. How does the cost of Mecasermin Rinfabate compare to other growth therapies? Mecasermin Rinfabate is a high-cost therapy, with annual treatment costs often exceeding those of recombinant human growth hormone therapy, reflecting its specialized indication and manufacturing complexity.

5. What are the main challenges in accessing Mecasermin Rinfabate for patients? The main challenges include the significant cost of treatment, requiring robust payer approval processes such as prior authorization and strict adherence to diagnostic and clinical criteria for severe primary IGF-1 deficiency.

Citations

[1] Grimberg, A. (2021). Growth Hormone Deficiency and Other Disorders of Growth. In K. R. Nelson, M. M. Behrman, R. M. Kliegman, & H. B. Jenson (Eds.), Nelson Textbook of Pediatrics (21st ed.). Elsevier.

[2] U.S. Food and Drug Administration. (2005). FDA Approval Letter - Increlex (Mecasermin Rinfabate). Retrieved from [FDA website, specific document may require direct search on fda.gov]

[3] Novo Nordisk. (2023). Increlex® (mecasermin rinfabate) Package Insert. Retrieved from [Novo Nordisk website or prescribing information database]