Last updated: February 17, 2026
What is NDC 76282-0546?
The National Drug Code (NDC) 76282-0546 identifies a specific pharmaceutical product. Based on available data, NDC 76282-0546 refers to Zimura (avacincaptad pegol), which is an intravitreal injection indicated for treating geographic atrophy secondary to age-related macular degeneration (AMD). It was developed by IVERIC bio.
Market Overview
- Therapeutic Landscape: Geographic atrophy (GA) linked to AMD lacks approved treatments until recently. Zimura received FDA approval for GA in July 2023, becoming one of the first pharmacologic options for this indication.
- Addressable Market: GA affects approximately 1-2 million Americans, with an annual growth rate of 8-10%. As of 2023, the total market in the U.S. estimates around $2 billion, projected to expand with increased awareness and diagnosis.
- Competitive Position: Zimura faces limited competition initially; ALZ-801 and other agents are in trials but lack approval. Its market entry depends heavily on efficacy, safety profile, and clinician acceptance.
Pricing History and Setting
-
Initial Launch Price: Based on comparable intravitreal therapies, initial retail price for Zimura was approximately $3,500 to $4,000 per injection.
-
Dosing Regimen: Administered monthly or quarterly. The approved dose is 2 mg per injection, with ongoing clinical data supporting quarterly administrations post-load doses.
-
Reimbursement Dynamics: Managed care plans often negotiate discounts, leading to net prices closer to $2,500 to $3,200 per injection. Pharma companies typically offer rebates, especially as insurance coverage expands.
Market Penetration and Adoption
- Adoption Timeline: Anticipated slow initial uptake due to conservative prescribing practices, with full utilization reaching 50-70% of the eligible population over 3-5 years.
- Pricing Strategies: Likely to include tiered discounts and contract incentives with payers. As competition rises, prices may decrease by 10-20% annually.
Price Projections (Next 5 Years)
| Year |
Estimated Average Price per Injection |
Notes |
| 2023 |
$3,800 |
Launch price, limited awareness |
| 2024 |
$3,500 |
Payer negotiations, initial adoption |
| 2025 |
$3,200 |
Increased competition, expanded market coverage |
| 2026 |
$2,900 |
Further payer rebates, biosimilar entry expected |
| 2027 |
$2,700 |
Market stabilization, increased volume sales |
Market Risks and Opportunities
-
Risks:
- Slow adoption due to the invasive nature of intravitreal injections
- Price erosion with increased competitors
- Reimbursement hurdles or delays
- Clinical trial data impacting perceived value
-
Opportunities:
- Expansion into international markets
- Combination therapy opportunities
- Long-term data supporting sustained efficacy could justify premium pricing
- Generic or biosimilar versions post-patent expiry may significantly reduce prices
Regulatory and Policy Impact
- Pending policy reforms, such as value-based pricing or increased PBM leverage, could influence actual net prices.
- Payment models favoring outcomes-based reimbursement could compress margins for innovator drugs.
Key Takeaways
- NDC 76282-0546 corresponds to Zimura, approved in July 2023 for GA.
- Initial prices range from $3,500 to $4,000 per injection, with a projected decline to approx. $2,700 by 2027.
- Market size is approximately $2 billion in the U.S., with rising growth prospects.
- Adoption rate and reimbursement rules significantly influence future pricing and revenue potential.
- Competition and regulatory changes are primary drivers of price erosion or stabilization over the next five years.
5 FAQs
1. How does the pricing of Zimura compare to other AMD treatments?
Zimura's price per injection is comparable to other intravitreal therapies like Lucentis or Eylea, which also range between $2,000 and $4,000.
2. What factors could accelerate the price decline?
Entry of biosimilar competitors, increased generic options, or insurers applying stricter formulary controls could push prices down faster.
3. Will reimbursement favor higher or lower prices?
Reimbursement policies, including negotiations and value-based models, tend to pressure prices downward, especially if clinical benefits are comparable across therapies.
4. How long is patent protection expected for Zimura?
Patent protection could extend until 2033-2035, depending on patent extensions and regulatory exclusivities.
5. Are there off-label uses that could impact the market?
No significant off-label applications are currently reported; the drug's focus remains on GA associated with AMD.
References
- IVERIC bio. Zimura (avacincaptad pegol) prescribing information. 2023.
- EvaluatePharma. Ophthalmology Market Outlook 2023.
- FDA. Approved drugs for geographic atrophy, July 2023.
- Statista. Number of AMD cases in the U.S., 2023.
- MarketWatch. Ophthalmic drugs pricing trends, 2022.
