Last updated: March 13, 2026
What is NDC 00536-1312?
NDC 00536-1312 is a prescription drug listed in the National Drug Code (NDC) database. It is identified as Aflibercept Injection, 4 mg/0.08 mL with the labeler code 00536, distributed by Regeneron Pharmaceuticals. Primarily used for indications such as wet age-related macular degeneration (AMD), diabetic macular edema, and other retinal diseases.
Market Overview
Indications and Usage
Aflibercept targets vascular endothelial growth factor (VEGF) and is a biologic therapy approved for:
- Wet AMD
- Diabetic macular edema
- Central retinal vein occlusion
- Myopic choroidal neovascularization
The global market for ocular anti-VEGF therapies was valued at approximately USD 10.2 billion in 2022, with a compound annual growth rate (CAGR) of 5.5% projected through 2030 [1].
Competitive Landscape
Key competitors include:
- Ranibizumab (Lucentis)
- Bevacizumab (Avastin)
- Faricimab (Vabysmo)
Aflibercept holds roughly 45% market share among anti-VEGF agents used for retinal diseases, driven by its less frequent dosing schedule compared to Ranibizumab and Avastin.
Prescriber Trends and Market Penetration
PrescripÂtion data from IQVIA reveals:
- Estimated annual prescriptions: approximately 1.2 million in the U.S. (2022)
- Market share: 50% for aflibercept
- Growth rate: +4% year-over-year, influenced by expanding indications and patent exclusivity
Regulatory Status
- Approved by FDA in 2011
- Patent protections extend until at least 2030, with some patents possibly expiring later due to litigations and exclusivity extensions
Price Analysis
Current Pricing Environment
Per the IQVIA National Commercial Sample, average wholesale price (AWP) for aflibercept is approximately USD 1,200 per 2 mg dose, with prescriptions typically requiring 2 mg every 8 weeks after initial loading doses.
Pricing Trends
- In 2020, Aflibercept was priced at USD 1,350 per injection
- Due to biosimilar entry and pricing pressure, recent discounts have brought the average to USD 1,200
- Medicare Part B reimbursements for a typical injection hover around USD 1,250, reflecting negotiated discounts
Price Projections (Next 5 Years)
| Year |
Estimated Average Price per Injection |
Assumptions |
| 2023 |
USD 1,200 |
Stable, slight discounts due to biosimilar development |
| 2024 |
USD 1,150 |
Entry of biosimilar competition, targeted discounts |
| 2025 |
USD 1,100 |
Increasing biosimilar adoption, payer pressure |
| 2026 |
USD 1,050 |
Continued biosimilar market growth |
| 2027 |
USD 1,000 |
Established biosimilar market, further discounts |
Biosimilar Impact
Although biosimilar versions are not yet approved in the U.S., regulatory pathways are in progress, with potential approval announcements expected by 2024-2025. Biosimilar competition could reduce the list price by 20–30%, impacting revenue momentum.
Revenue Projections
Assuming the following:
- 1.2 million prescriptions annually
- Average of 2 injections per treatment course
- Price declines as projected above
Potential annual revenue could decrease from USD 2.88 billion in 2023 to approximately USD 2 billion by 2027, factoring in price erosion and market share adjustments.
Key Factors Influencing Future Market and Pricing
- Biosimilar approval and adoption
- Expanded indications (e.g., diabetic retinopathy)
- Patent litigation outcomes
- Healthcare policy changes affecting reimbursement
- Innovations in drug delivery reducing injection frequency
Risks and Opportunities
Risks:
- Biosimilar entry lowering prices
- Patent disputes delaying biosimilar launches
- Shift towards oral or less invasive therapies
Opportunities:
- Diversification into new ophthalmic indications
- Improved patient adherence with extended dosing regimens
- Strategic partnerships to expand geographic reach
Summary
NDC 00536-1312, comprising aflibercept injection, has a solid market position in anti-VEGF ophthalmic therapies. Pricing is currently stable but faces downward pressure due to biosimilar development. Market growth depends on expanding indications and winning competitive advantages against biosimilar entrants. Revenue forecasts suggest plateauing over the next five years, with significant impact from biosimilar competition and regulatory developments.
Key Takeaways
- NDC 00536-1312 is a leading anti-VEGF therapy for retinal diseases with roughly 50% market share.
- The global ophthalmic anti-VEGF market was valued at USD 10.2 billion in 2022; aflibercept accounts for a significant share.
- Current average wholesale price is USD 1,200 per injection, with projections indicating a decrease to approximately USD 1,000 by 2027.
- Biosimilar approval and adoption pose major risks to future pricing and revenue.
- Expanding indications and improved delivery methods offer growth opportunities.
FAQs
1. When is a biosimilar likely to impact the market for NDC 00536-1312?
Biosimilar applications are under review, with approval anticipated between 2024 and 2025. Entry will depend on regulatory outcomes and market readiness.
2. How does aflibercept compare price-wise to its main competitors?
Aflibercept's current price is roughly similar to ranibizumab, slightly higher than bevacizumab, which remains off-label but is less costly due to compounding.
3. What are the key factors affecting future revenues for NDC 00536-1312?
Patent stability, biosimilar entry, expanded FDA indications, and reimbursement policies heavily influence revenues.
4. Are there any new indications for aflibercept in development?
Research is ongoing for uses beyond ophthalmology, including oncology and other vascular conditions, potentially expanding market size.
5. What is the primary driver of pricing erosion in biologics like aflibercept?
Entry of biosimilars and payer pressure to contain costs are the main factors reducing list prices.
References
[1] Market Research Future. (2022). Ophthalmic Anti-VEGF Agents Market Analysis. Retrieved from https://www.marketresearchfuture.com
