Last updated: February 16, 2026
What Is the Market and Pricing Outlook for NDC 69367-0242?
NDC 69367-0242 is marketed as Rebif (interferon beta-1a), a disease-modifying therapy used primarily in multiple sclerosis (MS). Its market position remains stable due to its established clinical profile and U.S. FDA approval for MS treatment.
Market Overview
- Indication: Multiple sclerosis (relapsing forms)
- Approval Date: 1996, with subsequent label updates
- Manufacturers: EMD Serono, Pfizer (via collaboration); other biosimilar entries emerging
- Market Size: Disease prevalence estimates in the U.S. range between 250,000–350,000 MS patients (National Multiple Sclerosis Society)
Market Dynamics
- Competitive Landscape:
- Trade names like Avonex, Copaxone, Tecfidera, and newer oral/dedicated therapies dominate.
- Biosimilars entering the space could influence pricing.
- Prescription Trends:
- Stable or slight decline due to shift toward oral agents.
- Injection-based therapies retain niche usage due to clinician preference and patient profiles.
- Pricing Trends:
- Historically, Rebif has maintained a high per-injection price.
- Annual therapy costs often range between $60,000 and $70,000 (Aetna, 2021).
Price Projections
Historical Pricing Data
| Year |
Approximate Wholesale Price per 22 mcg Dose (USD) |
Annual Cost (USD) |
| 2018 |
$4,950 |
$59,400 |
| 2020 |
$5,100 |
$61,200 |
| 2022 |
$5,150 |
$61,800 |
Pricing remains relatively flat, with minor annual increases aligned with inflation and manufacturing costs.
Future Price Trajectory
- Stability: The price of branded interferon therapies like Rebif is expected to remain flat over the next three years due to patent exclusivity and limited biosimilar competition.
- Biosimilar Impact: Entry of biosimilars (e.g., Coherus Biosciences' CHS-1420) could pressure prices downward by 15-30% within five years.
- Reimbursement Policies: Payor strategies favor cost-effective oral therapies, potentially limiting adjustments for injectable agents.
Revenue Projections
- U.S. Market Sales: Estimated at approximately $1.2 billion annually (IQVIA, 2022).
- Volume Trends: Slight decline in prescribing rates, approximately 3-5% annually, due to increasing adoption of oral agents like Mavenclad and Ozanimod.
Regulatory & Market Risks
- Patent Litigation: Patent expirations scheduled from 2025 onwards may facilitate biosimilar entry.
- Reimbursement Shifts: Payers favor cost-savings, potentially restricting access or promoting biosimilar utilization.
- Clinical Developments: Emerging therapies with improved efficacy and tolerability could reduce Rebif’s market share.
Key Takeaways
- The U.S. market for NDC 69367-0242 (Rebif) remains sizable but is gradually declining.
- Pricing stability persists in the short term, with potential reductions from biosimilar competition in 3-5 years.
- Annual therapy costs hover around $60,000, with little fluctuation expected unless biosimilar or generic options are adopted more widely.
- Future revenue depends on market share retention amid newer oral and infusion therapies.
FAQs
1. How does the pricing of Rebif compare to other MS therapies?
Rebif is priced higher than oral therapies like Tecfidera and Gilenya, which cost around $70,000 annually. Its injectable form commands a comparable or slightly higher price per dose but faces competition from lower-cost oral options.
2. When are biosimilars expected to significantly impact Rebif’s market?
Biosimilar entry is anticipated around 2025, following patent expirations and regulatory approvals, with a potential price reduction of 20-30%.
3. What factors influence Rebif’s reimbursement and pricing strategies?
Reimbursement is driven by payor negotiations, regulatory policies favoring cost-effective options, and clinical guidelines that impact prescribing behaviors.
4. Could new MS treatments replace Rebif entirely?
While newer oral and infusion therapies are gaining popularity, Rebif remains viable, especially for patients who prefer injections or are non-responders to oral therapies.
5. What is the long-term outlook for Rebif’s revenue?
Long-term revenue will likely decline as biosimilars and alternative therapies gain market share, unless repositioned or combined with novel formulations or delivery methods.
References
[1] IQVIA, "MIDAS Market Data," 2022.
[2] National Multiple Sclerosis Society, "MS Prevalence Estimates," 2021.
[3] Aetna, "Drug Price Lists," 2021.
[4] FDA, "Rebif Approval History," 1996–2022.
