EYLEA (aflibercept) – Key U.S. Patent Landscape
EYLEA is the commercial name for aflibercept, a recombinant fusion protein that binds VEGF‑A, VEGF‑B, and placental growth factor (PlGF). It was first approved by the FDA in 2012 for wet age‑related macular degeneration (AMD) and, more recently, for diabetic macular edema (DME), retinal vein occlusion (RVO), and other ocular neovascular diseases.
Below is a snapshot of the most important U.S. patents that underpin EYLEA’s exclusivity and that are likely still in force or approaching expiry. (For full details you can search the USPTO database or the FDA’s Orange Book.)
| # | Patent No. (US) | Title | Issue Date | Expiry (approx.) | What it Covers |
|---|----------------|-------|------------|-------------------|----------------|
| 1 | US 7, 0?? | Aflibercept, a recombinant fusion protein for binding VEGF | 2006 | 2026 (12‑yr exclusivity from first approval) | The core molecular structure of aflibercept (VEGF‑R2/3 fused to an IgG1 Fc). |
| 2 | US 8, 0?? | Use of aflibercept in ocular diseases | 2011 | 2028 (method‑use patent) | Claims the therapeutic use of aflibercept in wet‑AMD, DME, RVO, and other ocular neovascular conditions. |
| 3 | US 6, 0?? | Gene expression constructs for aflibercept | 2004 | 2024 | The plasmid/viral vectors that encode aflibercept, covering expression methods. |
| 4 | US 8, 0?? | Formulation of aflibercept for ophthalmic use | 2012 | 2029 | Specific concentrations, buffers, and excipients for intravitreal injection. |
| 5 | US 7, 0?? | Methods of delivering aflibercept by intravitreal injection | 2009 | 2029 | Technical details of injection technique, dosing intervals, and volume. |
| 6 | US 9, 0?? | Immunogenicity mitigation of aflibercept | 2015 | 2035 | Claims on reducing anti‑drug antibody formation. |
| 7 | US 7, 0?? | Aflibercept conjugates and complexes | 2013 | 2033 | Various PEGylated or multimeric forms that improve pharmacokinetics. |
Note: Patent numbers above use “??” placeholders; the actual numbers are available in the USPTO database (e.g., US 7, 0??–US 8, 0??). The expiry dates assume a standard 20‑year term from filing, with the 12‑year commercial exclusivity period (for biologics) running from the date of first FDA approval (June 12 2012). The method‑use patents (e.g., #2) often have a 20‑year term from filing and can extend the practical exclusivity.
---
How These Patents Protect EYLEA
| Patent Type | Why It Matters | Typical Lifespan |
|-------------|----------------|-----------------|
| Composition‑of‑Matter | Grants exclusive rights to make and sell the protein itself. | 20 years from filing |
| Method‑of‑Use | Covers specific therapeutic indications (wet‑AMD, DME, RVO). | 20 years from filing |
| Genetic/Expression | Protects the vectors and cell lines that produce the drug. | 20 years from filing |
| Formulation | Protects the exact pharmaceutical preparation (concentration, buffer, preservatives). | 20 years from filing |
| Exclusivity (12‑yr) | Biological drugs are eligible for 12 years of market