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FDA Purple Book · Reference family

aflibercept (Eylea)

aflibercept is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc., with 6 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

4

Biosimilars

2

Interchangeables

88

Listed patents

2011

Reference approved

Reference product

351(a)BLA 125387

Eylea aflibercept

Regeneron Pharmaceuticals, Inc.

Approved
Nov 18, 2011
Marketing
Rx
Center
CDER
Patents
88 listed

Molecular structure

Experimental 3D structure for aflibercept from the RCSB Protein Data Bank (PDB 5FV1).

3D molecular structure of aflibercept (PDB entry 5FV1)

Interactive biological assembly from PDB entry 5FV1. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.

Open in RCSB viewer PDB 5FV1 details

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for aflibercept, in chronological order.

  1. First licensure

    Date aflibercept was first licensed by the FDA.

    14 yr 9 mo ago

  2. Reference approval

    Approval date of the reference aflibercept product.

    14 yr 9 mo ago

  3. Patent 10,857,231 expires

    Published Purple Book patent expiration.

    4 yr 3 mo ago

  4. Patent 7,070,959 expires

    Published Purple Book patent expiration.

    3 yr ago

  5. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    2 yr 1 mo ago

  6. Patent 10,406,226 expires

    Published Purple Book patent expiration.

    2 mo ago

  7. Patent 10,464,992 expires

    Published Purple Book patent expiration.

    in 1 yr 1 mo

  8. Patent 11,066,458 expires

    Published Purple Book patent expiration.

    in 1 yr 1 mo

  9. Patent 11,084,865 expires

    Published Purple Book patent expiration.

    in 1 yr 1 mo

  10. Patent 11,732,024 expires

    Published Purple Book patent expiration.

    in 1 yr 1 mo

  11. Patent 10,415,055 expires

    Published Purple Book patent expiration.

    in 2 yr

  12. Patent 9,562,238 expires

    Published Purple Book patent expiration.

    in 2 yr

  13. Patent 9,932,605 expires

    Published Purple Book patent expiration.

    in 2 yr

  14. Patent 7,771,997 expires

    Published Purple Book patent expiration.

    in 2 yr 1 mo

  15. Patent 9,222,106 expires

    Published Purple Book patent expiration.

    in 2 yr 1 mo

  16. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 3 yr 9 mo

  17. Patent 10,130,681 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  18. Patent 10,828,345 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  19. Patent 10,857,205 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  20. Patent 10,888,601 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  21. Patent 11,253,572 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  22. Patent 11,559,564 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  23. Patent 11,707,506 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  24. Patent 11,975,045 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  25. Patent 11,986,511 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  26. Patent 12,268,730 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  27. Patent 9,669,069 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  28. Patent 9,254,338 expires

    Published Purple Book patent expiration.

    in 6 yr 1 mo

  29. Patent 11,332,771 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  30. Patent 11,970,724 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  31. Patent D858,754 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  32. Patent 9,315,281 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  33. Patent 11,268,109 expires

    Published Purple Book patent expiration.

    in 9 yr 6 mo

  34. Patent 11,788,102 expires

    Published Purple Book patent expiration.

    in 9 yr 6 mo

  35. Patent 9,816,110 expires

    Published Purple Book patent expiration.

    in 9 yr 6 mo

  36. Patent D906,102 expires

    Published Purple Book patent expiration.

    in 9 yr 9 mo

  37. Patent 10,927,342 expires

    Published Purple Book patent expiration.

    in 10 yr 4 mo

  38. Patent 11,312,936 expires

    Published Purple Book patent expiration.

    in 10 yr 4 mo

  39. Patent 12,221,619 expires

    Published Purple Book patent expiration.

    in 10 yr 4 mo

  40. Patent D934,069 expires

    Published Purple Book patent expiration.

    in 10 yr 7 mo

  41. Patent 11,549,154 expires

    Published Purple Book patent expiration.

    in 10 yr 9 mo

  42. Patent 10,669,594 expires

    Published Purple Book patent expiration.

    in 10 yr 10 mo

  43. Patent 11,918,785 expires

    Published Purple Book patent expiration.

    in 11 yr 3 mo

  44. Patent 10,182,969 expires

    Published Purple Book patent expiration.

    in 11 yr 3 mo

  45. Patent D961,376 expires

    Published Purple Book patent expiration.

    in 11 yr 5 mo

  46. Patent D961,377 expires

    Published Purple Book patent expiration.

    in 11 yr 5 mo

  47. Patent 11,577,025 expires

    Published Purple Book patent expiration.

    in 11 yr 6 mo

  48. Patent 11,680,930 expires

    Published Purple Book patent expiration.

    in 11 yr 7 mo

  49. Patent 10,905,786 expires

    Published Purple Book patent expiration.

    in 11 yr 11 mo

  50. Patent 10,918,754 expires

    Published Purple Book patent expiration.

    in 11 yr 11 mo

  51. Patent 12,116,622 expires

    Published Purple Book patent expiration.

    in 12 yr 2 mo

  52. Patent 11,769,597 expires

    Published Purple Book patent expiration.

    in 12 yr 5 mo

  53. Patent 11,433,186 expires

    Published Purple Book patent expiration.

    in 12 yr 9 mo

  54. Patent 12,168,036 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  55. Patent 11,103,552 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  56. Patent 10,973,879 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  57. Patent 12,280,093 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  58. Patent D1,035,436 expires

    Published Purple Book patent expiration.

    in 13 yr 4 mo

  59. Patent D1,042,107 expires

    Published Purple Book patent expiration.

    in 13 yr 6 mo

  60. Patent 11,850,407 expires

    Published Purple Book patent expiration.

    in 13 yr 6 mo

  61. Patent D1,047,700 expires

    Published Purple Book patent expiration.

    in 13 yr 7 mo

  62. Patent 10,961,500 expires

    Published Purple Book patent expiration.

    in 13 yr 10 mo

  63. Patent 11,286,460 expires

    Published Purple Book patent expiration.

    in 13 yr 10 mo

  64. Patent 11,555,176 expires

    Published Purple Book patent expiration.

    in 13 yr 10 mo

  65. Patent 11,821,001 expires

    Published Purple Book patent expiration.

    in 13 yr 10 mo

  66. Patent 11,439,758 expires

    Published Purple Book patent expiration.

    in 14 yr 3 mo

  67. Patent 11,478,588 expires

    Published Purple Book patent expiration.

    in 14 yr 4 mo

  68. Patent 11,160,918 expires

    Published Purple Book patent expiration.

    in 14 yr 4 mo

  69. Patent 11,793,926 expires

    Published Purple Book patent expiration.

    in 14 yr 4 mo

  70. Patent 11,053,280 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  71. Patent 11,104,715 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  72. Patent 11,174,283 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  73. Patent 11,186,625 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  74. Patent 11,299,532 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  75. Patent 11,306,135 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  76. Patent 11,459,373 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  77. Patent 11,459,374 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  78. Patent 11,472,861 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  79. Patent 11,485,770 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  80. Patent 11,505,593 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  81. Patent 11,535,663 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  82. Patent 11,542,317 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  83. Patent 11,548,932 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  84. Patent 11,649,273 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  85. Patent 11,732,025 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  86. Patent 11,753,459 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  87. Patent 12,054,533 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  88. Patent 12,077,570 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  89. Patent 12,202,883 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  90. Patent 11,525,833 expires

    Published Purple Book patent expiration.

    in 14 yr 9 mo

  91. Patent 12,282,004 expires

    Published Purple Book patent expiration.

    in 15 yr 9 mo

  92. Patent 12,163,122 expires

    Published Purple Book patent expiration.

    in 16 yr 2 mo

Biosimilars & interchangeables for aflibercept

6 FDA-licensed follow-on biologics referencing aflibercept.

Biosimilars and interchangeable biosimilars referencing aflibercept.
ProductProper nameApplicantTypeBLAApproved
Opuvizaflibercept-yszySamsung Bioepis Co., Ltd.Interchangeable761350May 20, 2024
Yesafiliaflibercept-jbvfBiocon Biologics Inc.Interchangeable761274May 20, 2024
Ahzantiveaflibercept-mrbbFormycon AGBiosimilar 351(k)761378Jun 28, 2024
Enzeevuaflibercept-abzvSandoz Inc.Biosimilar 351(k)761382Aug 09, 2024
Pavbluaflibercept-ayyhAmgen Inc.Biosimilar 351(k)761298Aug 23, 2024
Eydenzeltaflibercept-boavCELLTRION, Inc.Biosimilar 351(k)761377Oct 02, 2025

Published patents

Patents the BLA holder has published in the FDA Purple Book Patent List for aflibercept.

Published Purple Book patents for aflibercept.
PatentExpiresIn
10,857,231Mar 14, 20224 yr 3 mo ago
7,070,959Jun 16, 20233 yr ago
10,406,226Mar 22, 20262 mo ago
10,464,992Jun 14, 2027in 1 yr 1 mo
11,066,458Jun 14, 2027in 1 yr 1 mo
11,084,865Jun 14, 2027in 1 yr 1 mo
11,732,024Jun 14, 2027in 1 yr 1 mo
10,415,055Jun 04, 2028in 2 yr
9,562,238Jun 04, 2028in 2 yr
9,932,605Jun 04, 2028in 2 yr
7,771,997Jul 02, 2028in 2 yr 1 mo
9,222,106Jul 02, 2028in 2 yr 1 mo
10,130,681Jan 11, 2032in 5 yr 8 mo
10,828,345Jan 11, 2032in 5 yr 8 mo
10,857,205Jan 11, 2032in 5 yr 8 mo
10,888,601Jan 11, 2032in 5 yr 8 mo
11,253,572Jan 11, 2032in 5 yr 8 mo
11,559,564Jan 11, 2032in 5 yr 8 mo
11,707,506Jan 11, 2032in 5 yr 8 mo
11,975,045Jan 11, 2032in 5 yr 8 mo
11,986,511Jan 11, 2032in 5 yr 8 mo
12,268,730Jan 11, 2032in 5 yr 8 mo
9,669,069Jan 11, 2032in 5 yr 8 mo
9,254,338May 22, 2032in 6 yr 1 mo
11,332,771Mar 14, 2034in 7 yr 11 mo
11,970,724Mar 14, 2034in 7 yr 11 mo
D858,754Sep 03, 2034in 8 yr 5 mo
9,315,281Sep 16, 2034in 8 yr 5 mo
11,268,109Oct 21, 2035in 9 yr 6 mo
11,788,102Oct 21, 2035in 9 yr 6 mo
9,816,110Oct 21, 2035in 9 yr 6 mo
D906,102Dec 29, 2035in 9 yr 9 mo
10,927,342Aug 03, 2036in 10 yr 4 mo
11,312,936Aug 03, 2036in 10 yr 4 mo
12,221,619Aug 03, 2036in 10 yr 4 mo
D934,069Oct 26, 2036in 10 yr 7 mo
11,549,154Dec 25, 2036in 10 yr 9 mo
10,669,594Feb 12, 2037in 10 yr 10 mo
11,918,785Jun 29, 2037in 11 yr 3 mo
10,182,969Jul 13, 2037in 11 yr 3 mo
D961,376Aug 23, 2037in 11 yr 5 mo
D961,377Aug 23, 2037in 11 yr 5 mo
11,577,025Oct 06, 2037in 11 yr 6 mo
11,680,930Oct 25, 2037in 11 yr 7 mo
10,905,786Mar 06, 2038in 11 yr 11 mo
10,918,754Mar 06, 2038in 11 yr 11 mo
12,116,622May 25, 2038in 12 yr 2 mo
11,769,597Aug 15, 2038in 12 yr 5 mo
11,433,186Dec 12, 2038in 12 yr 9 mo
12,168,036May 10, 2039in 13 yr 2 mo
11,103,552May 15, 2039in 13 yr 2 mo
10,973,879May 17, 2039in 13 yr 2 mo
12,280,093May 17, 2039in 13 yr 2 mo
D1,035,436Jul 16, 2039in 13 yr 4 mo
D1,042,107Sep 17, 2039in 13 yr 6 mo
11,850,407Sep 18, 2039in 13 yr 6 mo
D1,047,700Oct 22, 2039in 13 yr 7 mo
10,961,500Jan 27, 2040in 13 yr 10 mo
11,286,460Jan 27, 2040in 13 yr 10 mo
11,555,176Jan 27, 2040in 13 yr 10 mo
11,821,001Jan 27, 2040in 13 yr 10 mo
11,439,758Jun 04, 2040in 14 yr 3 mo
11,478,588Jul 25, 2040in 14 yr 4 mo
11,160,918Jul 29, 2040in 14 yr 4 mo
11,793,926Jul 29, 2040in 14 yr 4 mo
11,053,280Aug 18, 2040in 14 yr 5 mo
11,104,715Aug 18, 2040in 14 yr 5 mo
11,174,283Aug 18, 2040in 14 yr 5 mo
11,186,625Aug 18, 2040in 14 yr 5 mo
11,299,532Aug 18, 2040in 14 yr 5 mo
11,306,135Aug 18, 2040in 14 yr 5 mo
11,459,373Aug 18, 2040in 14 yr 5 mo
11,459,374Aug 18, 2040in 14 yr 5 mo
11,472,861Aug 18, 2040in 14 yr 5 mo
11,485,770Aug 18, 2040in 14 yr 5 mo
11,505,593Aug 18, 2040in 14 yr 5 mo
11,535,663Aug 18, 2040in 14 yr 5 mo
11,542,317Aug 18, 2040in 14 yr 5 mo
11,548,932Aug 18, 2040in 14 yr 5 mo
11,649,273Aug 18, 2040in 14 yr 5 mo
11,732,025Aug 18, 2040in 14 yr 5 mo
11,753,459Aug 18, 2040in 14 yr 5 mo
12,054,533Aug 18, 2040in 14 yr 5 mo
12,077,570Aug 18, 2040in 14 yr 5 mo
12,202,883Aug 18, 2040in 14 yr 5 mo
11,525,833Nov 29, 2040in 14 yr 9 mo
12,282,004Dec 09, 2041in 15 yr 9 mo
12,163,122May 10, 2042in 16 yr 2 mo

Frequently asked questions

What biosimilars are approved for aflibercept (Eylea)?

The FDA Purple Book lists 6 approved follow-on biologics referencing aflibercept: Opuviz, Yesafili, Ahzantive, Enzeevu, Pavblu, and Eydenzelt. Of these, 2 are interchangeable biosimilars and 4 are 351(k) biosimilars.

When does aflibercept (Eylea) lose reference-product exclusivity?

aflibercept's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending May 18, 2024.

Is there an interchangeable biosimilar for aflibercept?

Yes. Opuviz and Yesafili are approved as interchangeable biosimilars for aflibercept, meaning they may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

Who makes aflibercept biosimilars?

Companies with FDA-approved follow-on biologics referencing aflibercept include Samsung Bioepis Co., Ltd., Biocon Biologics Inc., Formycon AG, Sandoz Inc., Amgen Inc., and CELLTRION, Inc..

How many patents are listed for aflibercept (Eylea) in the Purple Book?

88 patents are published in the FDA Purple Book Patent List for aflibercept.

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