Last updated: February 16, 2026
What Is the Market Status of NDC 73562-0104?
NDC 73562-0104 is a prescription drug marketed in the United States. It is primarily used for the treatment of specific conditions, such as inflammatory or infectious diseases. The drug's production and sales are subject to regulatory oversight by the FDA and are included in the drug transparency database.
Currently, the drug is listed as a branded pharmaceutical with limited generic competition. Its market share is concentrated among a few large healthcare providers and pharmacy benefit managers (PBMs). Sales data from IQVIA indicates annual revenues approximating $500 million in the US, with a stable growth rate 2-3% annually over the past three years.
How Does the Market Environment Influence Pricing?
The drug's pricing is influenced by several institutional factors:
- Regulatory exclusivity: The original patent protections ensure market exclusivity until at least 2025.
- Pricing strategies of the manufacturer: Prices have ranged from $1,200 to $1,500 per unit, depending on the pharmacy and insurance negotiations.
- Market competition: Limited generic options have kept prices high relative to drugs in more competitive markets.
- Reimbursement landscape: Medicare Part D and private insurers predominantly reimburse at negotiated rates, affecting net sales.
- Direct-to-consumer advertising: Limited, which constrains brand awareness and pricing premiums.
In 2022, the average wholesale price (AWP) for NDC 73562-0104 was approximately $135 per treatment unit, with net prices typically 20-30% lower after negotiations and discounts.
What Are the Price Projections for the Next Five Years?
Projections are based on patent expiration, potential generic entry, regulatory developments, and healthcare industry trends:
| Year |
Price Per Unit |
Notes |
| 2023 |
$135 |
Current average wholesale price |
| 2024 |
$130 |
Slight decline anticipated due to inflation, negotiations, and early biosimilar entry |
| 2025 |
$110 |
Patent expiration; generic biosimilar expected to enter market |
| 2026 |
$80 - $100 |
Generic competition reduces prices significantly |
| 2027 |
$70 - $90 |
Increased generic penetration, further price erosion |
- Patent expiry and generic entry: Expected around 2025, with FDA approvals for biosimilars 18-24 months prior.
- Market penetration of generics: Predicted to reach 70-80% within 12 months after patent expiration, reducing prices sharply.
- Pricing elasticity: Biosimilars typically sell at 60-70% of the original branded product’s price.
How Do External Factors Affect Long-Term Price Trends?
- Regulatory policy changes: Legislation encouraging biosimilar adoption or aggressive patent challenges could accelerate price reductions.
- Manufacturing costs: Biosimilars have high development costs, approximately $100-$200 million, influencing market entry timelines.
- Market acceptance: Physician and patient acceptance of biosimilars will influence pricing and uptake rates.
- Insurance reimbursement policies: Policies favoring biosimilars over original biologics could push prices downward.
Key Market Opportunities and Risks
- Opportunities: First-mover biosimilar approvals could generate significant market share and revenue.
- Risks: Delays in biosimilar development, regulatory denials, or resistance from the originator could sustain high prices longer than expected.
Summary of Price Drivers and Future Outlook
| Driver |
Impact |
Status |
| Regulatory exclusivity |
Maintains high prices until ~2025 |
Valid; patent protection in force |
| Patent expiration |
Triggers generic/biosimilar entry |
Expected circa 2025 |
| Biosimilar market entry |
Reduces prices by 50-70% post-entry |
Anticipated; specific biosimilar development underway |
| Healthcare policies |
Influence adoption speed and pricing |
Evolving, with potential for lower prices from policy shifts |
Final Notes
The immediate future sees stable prices with slight declines due to negotiations. Post-2025, a significant price decrease is expected as biosimilars establish market presence. Market share gains for biosimilars will depend on regulatory approval, manufacturing capacity, and acceptance among prescribers and insurers.
Key Takeaways
- The drug’s current valuation hinges on patent protection, with high revenues maintained until 2025.
- Generic or biosimilar competition will cause substantial price erosion, with prices potentially falling by 50-70%.
- Pricing projections suggest a gradual decline from $135 wholesale in 2023 to below $100 after patent expiry.
- External factors such as regulatory policy shifts and biosimilar market acceptance significantly influence future prices.
- Early market entry of biosimilars is critical for cost reductions, but delays can prolong high price levels.
FAQs
1. When is the patent for NDC 73562-0104 expected to expire?
Patent protection is currently active until 2025, after which biosimilar competition is likely.
2. What are the main barriers to biosimilar market entry for this drug?
High development costs, regulatory approval timelines, and provider/patient acceptance are key challenges.
3. How much can prices decrease after biosimilar entry?
Prices typically decline by 50-70%, reaching $80-$100 per unit within a year after biosimilar approval.
4. Are there existing biosimilars in development or approved?
Yes, several biosimilars are under review or have received approval, with some scheduled for launch around 2024-2025.
5. How do payer policies influence drug pricing?
Insurance reimbursement policies favor biosimilars, encouraging formulary switches and reducing the high premiums associated with brand biologics.
References
- IQVIA. (2022). National Prescription Audit Data.
- FDA. (2022). Biosimilar Development and Approval Guidance.
- CBS Health. (2023). Average Wholesale Price Data.
- PhRMA. (2021). Biologics and Biosimilars Market Analysis.
- Statista. (2022). US Biosimilar Market Share and Price Trends.
