Last updated: February 21, 2026
What Is NDC 49884-0111?
NDC 49884-0111 is the identifier for Invossa, an investigational gene therapy for cartilage regeneration, primarily targeted at patients with osteoarthritis. It is developed by Kolon TissueGene. The product remains in clinical trial phases and has not yet received FDA approval for commercial sale.
Current Market Position
- Indication: Osteoarthritis treatment, especially knee joint cartilage restoration
- Phase: Clinical trials, specifically Phase 3 as of 2022
- Clinical Trial Status: Pending FDA approval, potential approval expected within the next 12-24 months, depending on trial outcomes
- Regulatory Status: Not yet approved; submitted New Drug Application (NDA) or Biologics License Application (BLA) in progress or anticipated
Market Size and Demand Drivers
| Category |
Data Points |
| Osteoarthritis prevalence |
~32.5 million US adults affected (CDC, 2018) |
| Knee osteoarthritis |
Approx. 12 million cases in US (Arthritis Foundation, 2020) |
| Unmet needs |
Limited regenerative options; high demand for effective cartilage repair |
| Current treatments |
NSAIDs, corticosteroids, physical therapy, and total knee replacements |
Competitive Landscape
| Competitor |
Product/Approach |
Approval Status |
Market Share (Estimated) |
| Genzyme (Sanofi) |
Carticel (Autologous chondrocyte implantation) |
Approved for specific uses |
Small, niche market |
| Zimmer Biomet |
DeNovo NT Graft |
Approved |
Growing rapidly, niche |
| Novartis (future) |
GRAIL (Gene therapy candidates) |
Early research phase |
Limited data, high potential |
Invossa's unique positioning as a regenerative gene therapy distinguishes it from existing cartilage repair options by potentially offering longer-lasting results and less invasive procedures.
Regulatory and Reimbursement Outlook
- FDA Status: Pending approval based on Phase 3 data. Potential approval within 12-24 months if trials succeed.
- Pricing Strategy: Gene therapies are expected to command high prices; comparable treatments range from $30,000 to over $100,000 per course.
- Reimbursement: Payer reimbursement will depend on demonstrated cost-effectiveness, safety, and long-term benefits shown during clinical trials.
Price Projections
| Scenario |
Approximate Price Range |
Key Assumptions |
| Base Case |
$50,000 - $70,000 |
Pending FDA approval, high demand, competitive differentiation |
| Optimistic Case |
$80,000 - $100,000 |
Proven superior long-term benefits, favorable reimbursement policies |
| Pessimistic Case |
$30,000 - $50,000 |
Delayed approval, safety concerns, less market penetration |
Notes:
- Prices are comparable to other gene and regenerative therapies such as Zolgensma and Luxturna.
- The final price point will depend on manufacturing costs, clinical trial outcomes, competitive dynamics, and payer negotiations.
Market Entry Considerations
- Clinical trial outcomes are critical. Successful demonstration of safety and efficacy can accelerate regulatory approval.
- Strategic partnerships with payers can facilitate reimbursement.
- The competitive pipeline includes other regenerative and cell-based therapies, but Invossa's gene therapy approach has the potential for differentiation.
Timeline Overview
| Milestone |
Estimated Date |
Significance |
| Completion of Phase 3 Trials |
2023-2024 |
Key data submission for FDA review |
| FDA Submission |
Q2 2024 |
Regulatory decision-making |
| Potential Market Launch |
2025-2026 |
First entry into the commercial market |
Risks and Challenges
- Clinical trial safety issues pose a risk to approval.
- Manufacturing complexity and costs could impact pricing and reimbursement negotiations.
- Competitive landscape dynamics may influence market share and pricing.
Key Takeaways
- NDC 49884-0111 (Invossa) is in late-stage clinical development for osteoarthritis cartilage regeneration.
- Market potential is significant, driven by a large unmet need in knee osteoarthritis.
- Price projections suggest a range between $30,000 to over $100,000, based on approval timing and clinical success.
- Successful commercialization depends on regulatory approval, reimbursement strategies, and competitive positioning.
- A delayed approval or safety issues could reduce market opportunities and pricing potential.
FAQs
1. When might Invossa be commercially available?
Potentially by 2025-2026, depending on the pace and results of ongoing clinical trials and FDA review.
2. How does Invossa compare to existing osteoarthritis treatments?
It aims to offer longer-lasting cartilage regeneration, potentially reducing the need for repeated procedures or joint replacements.
3. What are the main risks to market success?
Clinical failure, safety concerns, manufacturing costs, and reimbursement barriers.
4. What is the expected price range for Invossa if approved?
Between $30,000 and $100,000 per course, with variations based on clinical and market dynamics.
5. How does Invossa's approach differ from competitors?
It is a gene therapy designed for cartilage regeneration, unlike existing cell therapy options, which rely on autologous tissue implants.
References
- Centers for Disease Control and Prevention. (2018). Osteoarthritis data.
- Arthritis Foundation. (2020). Osteoarthritis statistics.
- FDA. (2022). Drug development and approval processes.
- MarketWatch. (2023). Gene therapy pricing overview.
- IQVIA. (2022). Regenerative medicine market trends.
[1] CDC. (2018). Osteoarthritis data.
[2] Arthritis Foundation. (2020). Osteoarthritis statistics.
[3] FDA. (2022). Drug approval process insights.
[4] MarketWatch. (2023). Gene therapy pricing analysis.
[5] IQVIA. (2022). Market trends in regenerative medicine.
