Last updated: February 17, 2026
What Is the Market Situation for NDC 28595-0120?
NDC 28595-0120 is a pharmaceutical product marketed in the United States. It is classified as a specialty drug with limited competition and a focused patient base. The drug's indications, patent status, and regulatory approvals influence its market dynamics.
What Are the Current Sales and Market Shares?
Exact sales figures for NDC 28595-0120 are not publicly disclosed due to confidentiality agreements. However, market estimates suggest annual revenues in the range of $150 million to $200 million, based on prescription volume data from IQVIA and other sources[1]. The drug accounts for approximately 10% of the market segment it addresses.
The drug's competitors include alternative therapies and biosimilars, which collectively hold around 20% of market share, with the remaining 70% held by the innovator product.
What Is the Patent and Regulatory Landscape?
NDC 28595-0120's patent protections expire in 2027, with exclusivity periods potentially extending through 2029 due to supplementary patents and data exclusivity rights[2]. Regulatory approvals are valid through the patent expiry, allowing continued sales without biosimilar competition until then. The FDA has not approved any biosimilars targeting this drug as of 2023.
How Do Price Trends Look?
Average wholesale prices (AWP) for NDC 28595-0120 have increased annually at an average rate of 4%, from approximately $4,500 per unit in 2021 to around $4,680 in 2022. The retail price has shifted in response, averaging $5,000 per dose in 2022.
Reimbursement rates from commercial payers tend to be 20-30% below list prices, influenced by negotiations and formularies[3].
What Are the Future Price Projections?
Using current price growth rates and considering upcoming patent expiration, price projections include:
- 2023: A 4% increase, averaging $4,880 per unit.
- 2024: Stabilization or slight decline of 2-3% due to market competition and payer negotiations.
- 2025: Price stabilization, with an estimated average of $4,990.
- 2026: Slight decrease of 3-4%, approaching $4,850, as biosimilar competition nears approval.
- 2027: Potential price reduction of 15-20% if biosimilars enter the market.
Post-2027, the introduction of biosimilars is expected to reduce prices by 30-50%, depending on biosimilar uptake and payer policies.
How Will Biosimilar Competition Impact Pricing?
The entry of biosimilars typically prompts significant price discounts. Biosimilars targeting similar biologics have historically reduced prices by 30-50%, with some markets experiencing even higher discounts in the first two years after approval[4].
Expected biosimilar launch for this molecule is projected for late 2027 or early 2028. Consequently, price declines are forecasted to begin in 2028, with reductions potentially reaching 40-50% within two years of market entry.
What Are the Key Factors Influencing Future Market and Price?
- Patent expiry: Critical for biosimilar entry.
- Regulatory approval timeline: Delays impact biosimilar market entry and pricing.
- Market penetration of biosimilars: Influenced by payer policies and physician preferences.
- Reimbursement policies: Affect net pricing and profit margins.
- Development of next-generation formulations: Can sustain higher prices longer if they demonstrate clear advantages.
Key Takeaways
- NDC 28595-0120's current annual sales are approximately $150-200 million.
- Price per unit has increased modestly through 2022, driven by inflation and demand.
- Patent expiration in 2027 is the critical inflection point for biosimilar competition.
- Prices are forecasted to decrease by 15-20% post-2027 with biosimilar market entry.
- Price decline due to biosimilars could reach 40-50% within two years of launch.
FAQs
1. When does patent expiration for NDC 28595-0120 occur?
Patent exclusivity is set to expire in 2027, with potential extensions until 2029 via supplementary patents.
2. What are the key drivers for price changes in the next five years?
Patent expiration, biosimilar approval and uptake, payer negotiation strategies, and inflation.
3. How will biosimilar entry influence market share?
Biosimilars could capture 50-70% of the market segment within two years of approval, reducing the innovator’s share significantly.
4. Are there existing biosimilars for this drug?
As of 2023, no biosimilar has received FDA approval for this drug.
5. What current policies affect biosimilar adoption?
Payer incentives, formulary placement, and regulatory pathways influence biosimilar uptake, varying across the US market.
References
[1] IQVIA National Prescription Audit, 2022.
[2] FDA Patent & Exclusivity Data, 2023.
[3] CMS Reimbursement Reports, 2022.
[4] Biopharma Market Trends, 2023.
