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BLA

AFLIBERCEPT | B761355 | REGENERON PHARMACEUTICALS

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 18, 2035(3333 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 18, 2035	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jun. 19, 20456926 days remaining

Based on latest discovered patent 12338274(formulation) · relevance 92/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 1,155 patents →

Top 50 of 1,155 AI-discovered patents by relevance.

Composition

(13)

95/1009968674Grant: 2018-05-15 | Exp: 2038-05-10

95/1007521049Grant: 2009-04-21 | Exp: 2029-04-16

95/1007396664Grant: 2008-07-08 | Exp: 2028-07-03

95/1009139644Grant: 2015-09-22 | Exp: 2035-09-17

95/1007972598Grant: 2011-07-05 | Exp: 2031-06-30

95/1007635474Grant: 2009-12-22 | Exp: 2029-12-17

95/10011524053Grant: 2022-12-13 | Exp: 2042-12-08

95/1007399612Grant: 2008-07-15 | Exp: 2028-07-10

94/10011505593Grant: 2022-11-22 | Exp: 2042-11-17

92/10011306135Grant: 2022-04-19 | Exp: 2042-04-14

92/1007087411Grant: 2006-08-08 | Exp: 2026-08-03

92/10011958894Grant: 2024-04-16 | Exp: 2044-04-11

92/10011186625Grant: 2021-11-30 | Exp: 2041-11-25

Formulation

(17)

98/10012331099Grant: 2025-06-17 | Exp: 2045-06-12

95/1007807164Grant: 2010-10-05 | Exp: 2030-09-30

95/10011542317Grant: 2023-01-03 | Exp: 2042-12-29

95/1009636400Grant: 2017-05-02 | Exp: 2037-04-27

95/1007608261Grant: 2009-10-27 | Exp: 2029-10-22

95/10011667702Grant: 2023-06-06 | Exp: 2043-06-01

95/1008481046Grant: 2013-07-09 | Exp: 2033-07-04

94/10011426446Grant: 2022-08-30 | Exp: 2042-08-25

94/1009580489Grant: 2017-02-28 | Exp: 2037-02-23

93/1008921316Grant: 2014-12-30 | Exp: 2034-12-25

93/1007306799Grant: 2007-12-11 | Exp: 2027-12-06

92/10012338274Grant: 2025-06-24 | Exp: 2045-06-19

92/1009340594Grant: 2016-05-17 | Exp: 2036-05-12

92/10011066458Grant: 2021-07-20 | Exp: 2041-07-15

92/1009914763Grant: 2018-03-13 | Exp: 2038-03-08

92/10012168036Grant: 2024-12-17 | Exp: 2044-12-12

92/10011732024Grant: 2023-08-22 | Exp: 2043-08-17

Method of Use

(12)

95/10011730794Grant: 2023-08-22 | Exp: 2043-08-17

95/10011769597Grant: 2023-09-26 | Exp: 2043-09-21

95/10012116622Grant: 2024-10-15 | Exp: 2044-10-10

95/10010888601Grant: 2021-01-12 | Exp: 2041-01-07

95/10010973879Grant: 2021-04-13 | Exp: 2041-04-08

94/10011975045Grant: 2024-05-07 | Exp: 2044-05-02

92/10011439683Grant: 2022-09-13 | Exp: 2042-09-08

92/1007354578Grant: 2008-04-08 | Exp: 2028-04-03

92/1007354581Grant: 2008-04-08 | Exp: 2028-04-03

92/10011253572Grant: 2022-02-22 | Exp: 2042-02-17

92/10010525104Grant: 2020-01-07 | Exp: 2040-01-02

92/1007479272Grant: 2009-01-20 | Exp: 2029-01-15

Manufacturing

(8)

98/10012202883Grant: 2025-01-21 | Exp: 2045-01-16

96/10011732025Grant: 2023-08-22 | Exp: 2043-08-17

95/10012049489Grant: 2024-07-30 | Exp: 2044-07-25

95/10012054533Grant: 2024-08-06 | Exp: 2044-08-01

92/10011299532Grant: 2022-04-12 | Exp: 2042-04-07

92/10011548932Grant: 2023-01-10 | Exp: 2043-01-05

92/10011535663Grant: 2022-12-27 | Exp: 2042-12-22

92/10011649273Grant: 2023-05-16 | Exp: 2043-05-11

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761355

351(a) ReferenceLicensedCDERInjection

Proper Name

aflibercept

Applicant

Regeneron Pharmaceuticals, Inc.

Approval Date

18-Aug-23

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 6, 2026	SUPPL -5	View Letter (PDF)
Nov 21, 2025	SUPPL -10	View Letter (PDF)
Oct 11, 2024	SUPPL -6	View Letter (PDF)
Dec 15, 2023	SUPPL -1	View Letter (PDF)
Aug 22, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8MG(0.07ML;114.3MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2023-08-18 00:00:00

No patent or exclusivity listings for this strength.