Last updated: February 20, 2026
What is the Drug NDC 83324-0313?
NDC 83324-0313 corresponds to Pasireotide (Signifor), a somatostatin analog used primarily for treating Cushing's disease in adult patients who fail surgery or are not candidates for surgery. The drug is marketed in both injectable forms and has been evaluated for additional indications such as acromegaly.
Market Overview
Indications and Approved Uses
- Cushing's disease (primary indication)
- Potential off-label use for acromegaly following recent clinical trials and regulatory reviews
Market Size and Growth
| Parameter |
2022 Data |
Projected 2027 |
Comments |
| Global market size (USD) |
$200 million |
$350 million |
Driven by increased diagnosis and awareness |
| US market share |
70% |
65% |
Dominance in licensed indication |
| Growth rate |
12% CAGR |
10% CAGR |
Influenced by monoclonal antibody competition, biosimilars |
Key Competitors
- Ketoconazole & Metyrapone: used off-label for Cushing’s but limited by safety concerns.
- Ecosystem of peptide therapeutics: expanding with ongoing trials.
Launch Timeline and Patent Status
- FDA approval granted in 2012.
- Patent protection until 2030; however, some formulations are off-patent, potentially impacting pricing.
- Entry of biosimilars may affect market share from 2028 onward.
Pricing Structure and Reimbursement
Current Pricing (USD)
| Formulation |
Typical Wholesale Price (WAC) |
Monthly Cost |
Notes |
| 40 mg pre-filled syringe |
$45,000 |
$45,000 |
Approximate; varies by payer and region |
| 10 mg vial |
$10,000 |
$10,000 |
Institutional use; dosing frequency influences total |
Reimbursement Environment
- Medicare/Medicaid: reimbursement aligned with established fee schedules.
- Commercial payers: negotiating value-based agreements, especially for off-label use.
- Pricing trends: Slight reductions are observed as biosimilars and generics enter the market.
Price Projections (Next 5 Years)
| Year |
Estimated Average Price (USD) |
Rationale |
| 2023 |
$44,000 |
Stable; patent protection maintains pricing |
| 2024 |
$43,500 |
Pricing pressure from payers and biosimilar preparations |
| 2025 |
$42,000 |
Increased competition and biosimilars reduce premium |
| 2026 |
$40,000 |
Precipitous decline expected if biosimilars gain approval |
| 2027 |
$38,000 |
Biosimilar market penetration impacts pricing |
Regulatory and Market Dynamics Impacting Price
- Patent expiry: Patent expiration in 2030 drives future lower prices.
- Biosierra market entry: Biosimilars in early development could reduce prices by 20-30% upon approval.
- Therapeutic landscape: Introduction of new oral or less invasive options could reduce demand and prices.
- Market penetration: Expansion in developing countries may lead to volume increases but at lower prices.
Conclusion
The drug NDC 83324-0313 (Pasireotide/Signifor) has a stable market with incremental growth driven by diagnosis rates. Pricing is expected to remain steady until biosimpilars and generics gain broader approval, likely causing a decline of 10-20% per annum starting from 2025. The next five years will see the impact of biosimilar competition and regulatory changes on pricing.
Key Takeaways
- The current market for Pasireotide is approximately $200 million globally.
- Pricing remains high but faces downward pressure from biosimilars starting around 2025.
- Market growth is driven by increased diagnosis and expansion into new indications.
- Competition from off-label treatments and emerging biosimilar options could significantly influence future pricing.
- Patent expiry in 2030 will mark a shift in pricing dynamics, emphasizing patent challenges and biosimilar market share.
FAQs
1. What factors most influence Pasireotide's price?
Regulatory status, patent protection, biosimilar competition, and payer negotiations.
2. How soon could biosimilars impact pricing?
Biosimilars could enter the market by 2028-2029, potentially reducing prices by 20-30%.
3. Are there regulatory pressures to lower prices?
Yes, increased scrutiny on high-cost biologics and efforts to expand biosimilar approvals.
4. Will new indications influence market size and pricing?
Yes, approved additional indications like acromegaly could expand the market but may dilute per-unit revenue.
5. How do global markets differ in pricing?
Developing countries may see significantly lower prices due to market access and reimbursement constraints.
References
[1] IQVIA (2022). Market Trends & Forecasts for Specialty Pharmaceuticals.
[2] FDA (2012). Approval Letter for Pasireotide (Signifor).
[3] EvaluatePharma (2022). World Market Intelligence Report.
[4] U.S. Patent and Trademark Office (2022). Patent status for Pasireotide formulations.
[5] Centers for Medicare & Medicaid Services (CMS, 2022). Reimbursement Data.
