FDA.reportPublic FDA data

Eylea Purple Book BLA 125387

BLA number
125387
Proprietary names
Eylea
Proper names
aflibercept
Applicant
Regeneron Pharmaceuticals, Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
88 patents listed; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Eyleaaflibercept351(a)2MG/0.05MLInjectionIntravitrealSingle-Dose VialRxLicensed2011-11-18YES
002Eyleaaflibercept351(a)2MG/0.05MLInjectionIntravitrealPre-Filled SyringeRxLicensed2018-08-16YES

Biosimilar And Interchangeable Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761274Yesafiliaflibercept-jbvf351(k) InterchangeableRx2026-06-01
761298Pavbluaflibercept-ayyh351(k) BiosimilarRx2026-06-01
761350Opuvizaflibercept-yszy351(k) InterchangeableRx2026-06-01
761377Eydenzeltaflibercept-boav351(k) BiosimilarRx2026-06-01
761378Ahzantiveaflibercept-mrbb351(k) BiosimilarRx2026-06-01
761382Enzeevuaflibercept-abzv351(k) BiosimilarRx2026-06-01

Published Patent List#

Patent, Expiration, Source updated table
PatentExpirationSource updated
12,163,1222042-05-102025-06-11
12,282,0042041-12-092025-06-11
11,525,8332040-11-292025-06-11
11,053,2802040-08-182025-06-11
11,104,7152040-08-182025-06-11
11,174,2832040-08-182025-06-11
11,186,6252040-08-182025-06-11
11,299,5322040-08-182025-06-11
11,306,1352040-08-182025-06-11
11,459,3732040-08-182025-06-11
11,459,3742040-08-182025-06-11
11,472,8612040-08-182025-06-11
11,485,7702040-08-182025-06-11
11,505,5932040-08-182025-06-11
11,535,6632040-08-182025-06-11
11,542,3172040-08-182025-06-11
11,548,9322040-08-182025-06-11
11,649,2732040-08-182025-06-11
11,732,0252040-08-182025-06-11
11,753,4592040-08-182025-06-11
12,054,5332040-08-182025-06-11
12,077,5702040-08-182025-06-11
12,202,8832040-08-182025-06-11
11,160,9182040-07-292025-06-11
11,793,9262040-07-292025-06-11
11,478,5882040-07-252025-06-11
11,439,7582040-06-042025-06-11
10,961,5002040-01-272025-06-11
11,286,4602040-01-272025-06-11
11,555,1762040-01-272025-06-11
11,821,0012040-01-272025-06-11
D1,047,7002039-10-222025-06-11
11,850,4072039-09-182025-06-11
D1,042,1072039-09-172025-06-11
D1,035,4362039-07-162025-06-11
10,973,8792039-05-172025-06-11
12,280,0932039-05-172025-06-11
11,103,5522039-05-152025-06-11
12,168,0362039-05-102025-06-11
11,433,1862038-12-122025-06-11
11,769,5972038-08-152025-06-11
12,116,6222038-05-252025-06-11
10,905,7862038-03-062025-06-11
10,918,7542038-03-062025-06-11
11,680,9302037-10-252025-06-11
11,577,0252037-10-062025-06-11
D961,3762037-08-232025-06-11
D961,3772037-08-232025-06-11
10,182,9692037-07-132025-06-11
11,918,7852037-06-292025-06-11
10,669,5942037-02-122025-06-11
11,549,1542036-12-252025-06-11
D934,0692036-10-262025-06-11
10,927,3422036-08-032025-06-11
11,312,9362036-08-032025-06-11
12,221,6192036-08-032025-06-11
D906,1022035-12-292025-06-11
11,268,1092035-10-212025-06-11
11,788,1022035-10-212025-06-11
9,816,1102035-10-212025-06-11
9,315,2812034-09-162025-06-11
D858,7542034-09-032025-06-11
11,332,7712034-03-142025-06-11
11,970,7242034-03-142025-06-11
9,254,3382032-05-222025-06-11
10,130,6812032-01-112025-06-11
10,828,3452032-01-112025-06-11
10,857,2052032-01-112025-06-11
10,888,6012032-01-112025-06-11
11,253,5722032-01-112025-06-11
11,559,5642032-01-112025-06-11
11,707,5062032-01-112025-06-11
11,975,0452032-01-112025-06-11
11,986,5112032-01-112025-06-11
12,268,7302032-01-112025-06-11
9,669,0692032-01-112025-06-11
7,771,9972028-07-022025-06-11
9,222,1062028-07-022025-06-11
10,415,0552028-06-042025-06-11
9,562,2382028-06-042025-06-11
9,932,6052028-06-042025-06-11
10,464,9922027-06-142025-06-11
11,066,4582027-06-142025-06-11
11,084,8652027-06-142025-06-11
11,732,0242027-06-142025-06-11
10,406,2262026-03-222025-06-11
7,070,9592023-06-162025-06-11
10,857,231Disclaimer filed on March 14, 20222025-06-11

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2023-11-01U001Eylea351(a)RxRegeneron Pharmaceuticals, Inc.
2023-06-01U001Eylea351(a)RxRegeneron Pharmaceuticals, Inc.
2023-06-01U002Eylea351(a)RxRegeneron Pharmaceuticals, Inc.
2022-03-01U001Eylea351(a)RxRegeneron Pharmaceuticals, Inc.
2022-03-01U002Eylea351(a)RxRegeneron Pharmaceuticals, Inc.
2020-05-01R001Eylea351(a)RxRegeneron Pharmaceuticals, Inc.
2020-05-01R002Eylea351(a)RxRegeneron Pharmaceuticals, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Eylea351(a)RxLicensed2011-11-18
2020-05-01002Eylea351(a)RxLicensed2018-08-16