Last updated: March 13, 2026
What is the Drug Associated with NDC 68180-0280?
The NDC 68180-0280 corresponds to Rintatolimod, a synthetic double-stranded RNA molecule developed as an immunomodulator. It primarily targets chronic fatigue syndrome (CFS) and other immune-related conditions.
Current Market Status
Market Overview
- Indication: Approved in the US for the treatment of Chronic Fatigue Syndrome.
- Regulatory Status: Marketed as Ampligen by Hemispherx Biopharma (as of 2022). Approval gained in 1997 through FDA’s accelerated process for CFS.
- Pipeline: Limited; Rintatolimod remains the main marketed molecule under this NDC.
- Competitive Landscape: Few direct competitors; potential rivals include other immunotherapies and experimental treatments for CFS and related conditions.
Sales Performance
| Year |
Estimated US Sales |
Global Sales (Estimate) |
Key Factors |
| 2021 |
$10 million |
$15 million |
Limited FDA-approved patient population, slow adoption |
| 2022 |
$12 million |
$17 million |
Slight growth due to expanded awareness |
Market Challenges
- Limited FDA approval: Only approved for CFS under accelerated pathways; not broadly accepted.
- Pricing constraints: Pricing based on rare disease status, typically high per treatment course.
- Patient access: Restricted due to intravenous administration requiring medical supervision.
Price Projections
Current Pricing
- Average wholesale price (AWP): Approximately $30,000 per treatment course (based on 2022 data).
- Per-dose cost: $1,000–$2,000, depending on dosing and patient factors.
Future Price Trends
| Year |
Price Trend |
Rationale |
| 2023-2025 |
Stable to slight increase (~2%) |
Patent exclusivity maintains pricing power; regulatory constraints limit competition. |
| 2026-2030 |
Potential increase (~5%) annually |
Entry of biosimilars or alternative immunotherapies may exert downward pressure, but limited by demand growth. |
Market Impact Factors
- Regulatory developments: Any expanded approval for additional indications could boost pricing.
- Manufacturing costs: Stable, given synthetic nature; no significant margin pressures expected.
- Reimbursement policies: Payer adoption remains cautious; high out-of-pocket costs can restrict access, potentially limiting revenue growth.
Policy and Reimbursement
- Limited insurance coverage due to the rarity of the condition and FDA approval status.
- Privately insured patients are more likely to access treatment.
- Medicare and Medicaid coverage remain inconsistent, impacting volume.
Competitive Outlook
| Drug / Candidate |
Indication |
Approval Status |
Market Positioning |
Price Range |
| Ampligen (Rintatolimod) |
CFS |
Approved (FDA accelerated) |
First-mover in CFS |
~$30,000 per course |
| Other immunomodulators |
CFS and related conditions |
Experimental |
Not yet approved |
Varies; generally lower |
Investment and Development Outlook
- New clinical trials are unlikely without expanding indications or improved delivery methods.
- Competitive landscape is sparse but could evolve with advances in the immunotherapy segment.
- Pricing could face pressure if new entrants or biosimilars emerge or if regulatory hurdles change.
Summary
NDC 68180-0280 is associated with Rintatolimod, an immunomodulatory drug targeting a niche market for CFS treatment. Current sales are constrained by regulatory status and limited demand, with prices around $30,000 per treatment. Future revenues depend on regulatory developments, potential new indications, and competitive dynamics involving biosimilars.
Key Takeaways
- The drug remains a niche option with limited growth potential under current conditions.
- Pricing stability is expected in the near term; moderate increases are possible with expanded approval.
- Market entry of competitors or biosimilars could reduce pricing and revenue.
- Reimbursement remains uncertain, restricting broader patient access.
- Long-term projections hinge on regulatory and clinical developments beyond the existing landscape.
FAQs
1. Is Rintatolimod approved for indications beyond CFS?
No, currently approved solely for CFS under FDA's accelerated approval pathway.
2. What factors could lead to price increases?
Expanded indications, improved delivery methods, or regulatory approval for broader patient populations.
3. How does the market compare to similar immunomodulators?
Limited competition; most immunomodulators serve different indications with variable pricing, making Rintatolimod's niche pricing relatively stable.
4. What are the prospects for biosimilar entry?
Low; synthetic RNA molecules face manufacturing and regulatory hurdles that slow biosimilar development.
5. How might reimbursement policies affect long-term sales?
Restrictive reimbursement may limit patient access and sales growth, especially if coverage remains limited.
References
[1] FDA. (2022). FDA Approved Drugs Database.
[2] Hemispherx Biopharma. (2022). Ampligen Product Information.
[3] Market Research Future. (2022). Immunotherapy Market Analysis.
[4] IQVIA. (2022). Quarterly Prescription Data.
[5] U.S. Patent and Trademark Office. (2022). Patent Data for Rintatolimod.
