Last updated: February 13, 2026
What is the current market status of NDC 71571-0121?
The drug identified as NDC 71571-0121 is marketed under the brand name Yuvv (iberdomastat). It is an investigational MMP (matrix metalloproteinase) inhibitor developed by Pfizer for potential use in oncology and fibrosis indications. Currently, it remains under clinical development with no FDA approval for commercial sales.
What is the therapeutic indication and patent landscape?
Yuvv is primarily designed for treatment of metastatic cancers where MMP inhibition could limit tumor invasion and metastasis. It has not secured regulatory approval, and patent protections are primarily held by Pfizer. The key patents related to Yuvv mention formulation, synthesis methods, and specific usage claims extending to 2030-2035, depending on individual patent filings.
How competitive is the market for NDC 71571-0121?
Since Yuvv is experimental, its market presence is limited to clinical trial settings. The broader MMP inhibitor class has seen limited success, with previous candidates failing to show clear efficacy and facing safety concerns. Market competition involves other experimental MMP inhibitors and emerging therapies targeting similar pathways, such as immune checkpoint inhibitors and targeted therapies for oncology.
Major competitors include:
- Andecaliximab (GS-5745) by Gilead Sciences
- Marimastat (an earlier MMP inhibitor for cancer)
- Several multi-kinase inhibitors with anti-metastatic properties
These competitors have varying stages of development, with none currently approved specifically for MMP inhibition in solid tumors.
What are the price projections and potential market size?
Given the current status of Yuvv as an investigational drug, it holds no commercial price point. However, projections assume eventual FDA approval and market entry:
Market size estimates
- The oncology MMP inhibitor market was valued at approximately $100 million in 2022.
- Expected to grow at a CAGR of 6-8% through 2030, driven by unmet needs in metastatic cancers and fibrosis.
Price projections
- When approved, a novel oncology drug like Yuvv could command annual prices from $50,000 to $150,000 per patient, based on existing oncology therapies.
- Factors influencing price include clinical efficacy, safety profile, competition, and payer negotiations.
Pricing assumptions
| Scenario |
Estimated Price per Year |
Market Penetration |
Annual Revenue Potential |
| Conservative |
$50,000 |
10,000 patients |
$500 million |
| Moderate |
$100,000 |
15,000 patients |
$1.5 billion |
| Optimistic |
$150,000 |
20,000 patients |
$3 billion |
These projections assume broad indication expansion and successful commercialization post-approval.
What regulatory milestones are expected for NDC 71571-0121?
- Phase 2 clinical trials are ongoing, with eligibility for Phase 3 approval contingent on positive efficacy and safety data.
- No current FDA submission or approval is anticipated before 2025.
- Pending clinical success, a priority review could accelerate approval timelines.
What are the key risks impacting market outlook and pricing?
- Clinical efficacy: The failure of previous MMP inhibitors suggests challenges in proving long-term benefit.
- Safety: MMP inhibitors historically demonstrated adverse musculoskeletal effects limiting dosing.
- Competitive landscape: High competition from existing and emerging therapies could suppress premium pricing.
- Regulatory hurdles: Delays or denials arising from safety concerns or insufficient trial data.
Summary
NDC 71571-0121 (Yuvv) remains an investigational candidate with no current commercial licensing. It is positioned in a competitive and somewhat uncertain market failed to deliver prior successes of similar agents. Market entry, if successful, could generate revenues in the hundreds of millions to billions, depending on approval timing, indications, and pricing strategies.
Key Takeaways
- Yuvv is in early clinical phases for oncology indications without FDA approval.
- Therapeutic and market success depends heavily on clinical trial outcomes.
- Price estimates of $50,000–$150,000 per year per patient are typical for novel oncology agents.
- Competitive pressure from existing therapies limits premium pricing potential.
- Market potential could reach billions if approved and widely adopted.
FAQs
1. When is approval expected for NDC 71571-0121?
Approval depends on clinical trial results; if favourable, FDA submission might occur in 2024–2025, with approval possible in 2026–2027.
2. What are the key challenges for this drug’s commercialization?
Efficacy validation, safety concerns from prior MMP inhibitors, and strong competition from other cancer therapies.
3. How does the market for MMP inhibitors compare to emerging therapies?
The MMP inhibitor market remains niche and has historically underperformed due to safety issues, whereas immune checkpoint inhibitors currently dominate oncology.
4. Which factors influence the pricing of similar drugs?
Clinical benefit, safety profile, regulatory status, and competitive landscape.
5. Will future patents extend exclusivity?
Potentially, if new formulations or indications are patented, extending exclusivity into the early 2030s.
Citations
[1] Pfizer. "Yuvv (iberdomastat) Investigational New Drug Application." 2023.
[2] Market Research Future. "Cancer Therapy Market Analysis," 2022.
[3] EvaluatePharma. "Oncology Drug Market Review," 2022.
