Skip to content
Assyro AI
Purple Book reference family · 351(a) biologic

aflibercept (Eylea)

aflibercept is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc., with 6 approved follow-on biologics.

351(a) biologicBLA 125387 Regeneron Pharmaceuticals, Inc.
Biosimilars
4
Interchangeables
2
Listed patents
88
Reference approved
2011

Reference product

Originator biologic
351(a)BLA 125387

Eylea aflibercept

Regeneron Pharmaceuticals, Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
88 listed

Exclusivity & patent cliffs

Protection horizon

  1. First licensure

    Date aflibercept was first licensed by the FDA.

    15 yr 1 mo ago

  2. Reference approval

    Approval date of the reference aflibercept product.

    15 yr 1 mo ago

  3. Patent 10,857,231 expires

    Published Purple Book patent expiration.

    4 yr 7 mo ago

  4. Patent 7,070,959 expires

    Published Purple Book patent expiration.

    3 yr 4 mo ago

  5. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    2 yr 5 mo ago

  6. Patent 10,406,226 expires

    Published Purple Book patent expiration.

    6 mo ago

  7. Patent 10,464,992 expires

    Published Purple Book patent expiration.

    in 9 mo

  8. Patent 11,066,458 expires

    Published Purple Book patent expiration.

    in 9 mo

  9. Patent 11,084,865 expires

    Published Purple Book patent expiration.

    in 9 mo

  10. Patent 11,732,024 expires

    Published Purple Book patent expiration.

    in 9 mo

  11. Patent 10,415,055 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  12. Patent 9,562,238 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  13. Patent 9,932,605 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  14. Patent 7,771,997 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  15. Patent 9,222,106 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  16. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 3 yr 5 mo

  17. Patent 10,130,681 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  18. Patent 10,828,345 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  19. Patent 10,857,205 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  20. Patent 10,888,601 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  21. Patent 11,253,572 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  22. Patent 11,559,564 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  23. Patent 11,707,506 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  24. Patent 11,975,045 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  25. Patent 11,986,511 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  26. Patent 12,268,730 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  27. Patent 9,669,069 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  28. Patent 9,254,338 expires

    Published Purple Book patent expiration.

    in 5 yr 9 mo

  29. Patent 11,332,771 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  30. Patent 11,970,724 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  31. Patent D858,754 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  32. Patent 9,315,281 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  33. Patent 11,268,109 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

  34. Patent 11,788,102 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

  35. Patent 9,816,110 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

  36. Patent D906,102 expires

    Published Purple Book patent expiration.

    in 9 yr 5 mo

  37. Patent 10,927,342 expires

    Published Purple Book patent expiration.

    in 10 yr

  38. Patent 11,312,936 expires

    Published Purple Book patent expiration.

    in 10 yr

  39. Patent 12,221,619 expires

    Published Purple Book patent expiration.

    in 10 yr

  40. Patent D934,069 expires

    Published Purple Book patent expiration.

    in 10 yr 3 mo

  41. Patent 11,549,154 expires

    Published Purple Book patent expiration.

    in 10 yr 5 mo

  42. Patent 10,669,594 expires

    Published Purple Book patent expiration.

    in 10 yr 7 mo

  43. Patent 11,918,785 expires

    Published Purple Book patent expiration.

    in 10 yr 11 mo

  44. Patent 10,182,969 expires

    Published Purple Book patent expiration.

    in 11 yr

  45. Patent D961,376 expires

    Published Purple Book patent expiration.

    in 11 yr 1 mo

  46. Patent D961,377 expires

    Published Purple Book patent expiration.

    in 11 yr 1 mo

  47. Patent 11,577,025 expires

    Published Purple Book patent expiration.

    in 11 yr 2 mo

  48. Patent 11,680,930 expires

    Published Purple Book patent expiration.

    in 11 yr 3 mo

  49. Patent 10,905,786 expires

    Published Purple Book patent expiration.

    in 11 yr 8 mo

  50. Patent 10,918,754 expires

    Published Purple Book patent expiration.

    in 11 yr 8 mo

  51. Patent 12,116,622 expires

    Published Purple Book patent expiration.

    in 11 yr 10 mo

  52. Patent 11,769,597 expires

    Published Purple Book patent expiration.

    in 12 yr 1 mo

  53. Patent 11,433,186 expires

    Published Purple Book patent expiration.

    in 12 yr 5 mo

  54. Patent 12,168,036 expires

    Published Purple Book patent expiration.

    in 12 yr 10 mo

  55. Patent 11,103,552 expires

    Published Purple Book patent expiration.

    in 12 yr 10 mo

  56. Patent 10,973,879 expires

    Published Purple Book patent expiration.

    in 12 yr 10 mo

  57. Patent 12,280,093 expires

    Published Purple Book patent expiration.

    in 12 yr 10 mo

  58. Patent D1,035,436 expires

    Published Purple Book patent expiration.

    in 13 yr

  59. Patent D1,042,107 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  60. Patent 11,850,407 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  61. Patent D1,047,700 expires

    Published Purple Book patent expiration.

    in 13 yr 3 mo

  62. Patent 10,961,500 expires

    Published Purple Book patent expiration.

    in 13 yr 7 mo

  63. Patent 11,286,460 expires

    Published Purple Book patent expiration.

    in 13 yr 7 mo

  64. Patent 11,555,176 expires

    Published Purple Book patent expiration.

    in 13 yr 7 mo

  65. Patent 11,821,001 expires

    Published Purple Book patent expiration.

    in 13 yr 7 mo

  66. Patent 11,439,758 expires

    Published Purple Book patent expiration.

    in 13 yr 11 mo

  67. Patent 11,478,588 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  68. Patent 11,160,918 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  69. Patent 11,793,926 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  70. Patent 11,053,280 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  71. Patent 11,104,715 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  72. Patent 11,174,283 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  73. Patent 11,186,625 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  74. Patent 11,299,532 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  75. Patent 11,306,135 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  76. Patent 11,459,373 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  77. Patent 11,459,374 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  78. Patent 11,472,861 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  79. Patent 11,485,770 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  80. Patent 11,505,593 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  81. Patent 11,535,663 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  82. Patent 11,542,317 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  83. Patent 11,548,932 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  84. Patent 11,649,273 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  85. Patent 11,732,025 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  86. Patent 11,753,459 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  87. Patent 12,054,533 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  88. Patent 12,077,570 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  89. Patent 12,202,883 expires

    Published Purple Book patent expiration.

    in 14 yr 1 mo

  90. Patent 11,525,833 expires

    Published Purple Book patent expiration.

    in 14 yr 5 mo

  91. Patent 12,282,004 expires

    Published Purple Book patent expiration.

    in 15 yr 5 mo

  92. Patent 12,163,122 expires

    Published Purple Book patent expiration.

    in 15 yr 10 mo

Biosimilars & interchangeables for aflibercept

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing aflibercept.
ProductProper nameApplicantTypeBLAApproved
Opuvizaflibercept-yszySamsung Bioepis Co., Ltd.Interchangeable761350
Yesafiliaflibercept-jbvfBiocon Biologics Inc.Interchangeable761274
Ahzantiveaflibercept-mrbbFormycon AGBiosimilar 351(k)761378
Enzeevuaflibercept-abzvSandoz Inc.Biosimilar 351(k)761382
Pavbluaflibercept-ayyhAmgen Inc.Biosimilar 351(k)761298
Eydenzeltaflibercept-boavCELLTRION, Inc.Biosimilar 351(k)761377

Published patents

Purple Book patent list
Published Purple Book patents for aflibercept.
PatentExpiresIn
10,857,2314 yr 7 mo ago
7,070,9593 yr 4 mo ago
10,406,2266 mo ago
10,464,992in 9 mo
11,066,458in 9 mo
11,084,865in 9 mo
11,732,024in 9 mo
10,415,055in 1 yr 9 mo
9,562,238in 1 yr 9 mo
9,932,605in 1 yr 9 mo
7,771,997in 1 yr 10 mo
9,222,106in 1 yr 10 mo
10,130,681in 5 yr 5 mo
10,828,345in 5 yr 5 mo
10,857,205in 5 yr 5 mo
10,888,601in 5 yr 5 mo
11,253,572in 5 yr 5 mo
11,559,564in 5 yr 5 mo
11,707,506in 5 yr 5 mo
11,975,045in 5 yr 5 mo
11,986,511in 5 yr 5 mo
12,268,730in 5 yr 5 mo
9,669,069in 5 yr 5 mo
9,254,338in 5 yr 9 mo
11,332,771in 7 yr 7 mo
11,970,724in 7 yr 7 mo
D858,754in 8 yr 1 mo
9,315,281in 8 yr 1 mo
11,268,109in 9 yr 3 mo
11,788,102in 9 yr 3 mo
9,816,110in 9 yr 3 mo
D906,102in 9 yr 5 mo
10,927,342in 10 yr
11,312,936in 10 yr
12,221,619in 10 yr
D934,069in 10 yr 3 mo
11,549,154in 10 yr 5 mo
10,669,594in 10 yr 7 mo
11,918,785in 10 yr 11 mo
10,182,969in 11 yr
D961,376in 11 yr 1 mo
D961,377in 11 yr 1 mo
11,577,025in 11 yr 2 mo
11,680,930in 11 yr 3 mo
10,905,786in 11 yr 8 mo
10,918,754in 11 yr 8 mo
12,116,622in 11 yr 10 mo
11,769,597in 12 yr 1 mo
11,433,186in 12 yr 5 mo
12,168,036in 12 yr 10 mo
11,103,552in 12 yr 10 mo
10,973,879in 12 yr 10 mo
12,280,093in 12 yr 10 mo
D1,035,436in 13 yr
D1,042,107in 13 yr 2 mo
11,850,407in 13 yr 2 mo
D1,047,700in 13 yr 3 mo
10,961,500in 13 yr 7 mo
11,286,460in 13 yr 7 mo
11,555,176in 13 yr 7 mo
11,821,001in 13 yr 7 mo
11,439,758in 13 yr 11 mo
11,478,588in 14 yr 1 mo
11,160,918in 14 yr 1 mo
11,793,926in 14 yr 1 mo
11,053,280in 14 yr 1 mo
11,104,715in 14 yr 1 mo
11,174,283in 14 yr 1 mo
11,186,625in 14 yr 1 mo
11,299,532in 14 yr 1 mo
11,306,135in 14 yr 1 mo
11,459,373in 14 yr 1 mo
11,459,374in 14 yr 1 mo
11,472,861in 14 yr 1 mo
11,485,770in 14 yr 1 mo
11,505,593in 14 yr 1 mo
11,535,663in 14 yr 1 mo
11,542,317in 14 yr 1 mo
11,548,932in 14 yr 1 mo
11,649,273in 14 yr 1 mo
11,732,025in 14 yr 1 mo
11,753,459in 14 yr 1 mo
12,054,533in 14 yr 1 mo
12,077,570in 14 yr 1 mo
12,202,883in 14 yr 1 mo
11,525,833in 14 yr 5 mo
12,282,004in 15 yr 5 mo
12,163,122in 15 yr 10 mo

aflibercept: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for aflibercept.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo