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LEQEMBI IQLIK

BLA

LECANEMAB-IRMB | B761375 | EISAI INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 29, 2037(4075 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 29, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jan. 25, 20446415 days remaining

Based on latest discovered patent 11884737(method of use) · relevance 82/100

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

Discovered Patents

View all 147 patents →

Top 50 of 147 AI-discovered patents by relevance.

Composition

(34)

88/1007465705Grant: 2008-12-16 | Exp: 2028-12-11

85/1007425447Grant: 2008-09-16 | Exp: 2028-09-11

85/1008021661Grant: 2011-09-20 | Exp: 2031-09-15

82/10011447575Grant: 2022-09-20 | Exp: 2042-09-15

78/1009545086Grant: 2017-01-17 | Exp: 2037-01-12

78/1007323170Grant: 2008-01-29 | Exp: 2028-01-24

75/10011578120Grant: 2023-02-14 | Exp: 2043-02-09

75/1009969812Grant: 2018-05-15 | Exp: 2038-05-10

75/1007417128Grant: 2008-08-26 | Exp: 2028-08-21

75/1007888076Grant: 2011-02-15 | Exp: 2031-02-10

75/10010494416Grant: 2019-12-03 | Exp: 2039-11-28

75/1007192585Grant: 2007-03-20 | Exp: 2027-03-15

75/1009598484Grant: 2017-03-21 | Exp: 2037-03-16

75/1008318917Grant: 2012-11-27 | Exp: 2032-11-22

75/1008618042Grant: 2013-12-31 | Exp: 2033-12-26

75/10010836784Grant: 2020-11-17 | Exp: 2040-11-12

75/1007960142Grant: 2011-06-14 | Exp: 2031-06-09

75/10011091540Grant: 2021-08-17 | Exp: 2041-08-12

75/1008669345Grant: 2014-03-11 | Exp: 2034-03-06

72/1009260520Grant: 2016-02-16 | Exp: 2036-02-11

72/1009409950Grant: 2016-08-09 | Exp: 2036-08-04

72/1008303958Grant: 2012-11-06 | Exp: 2032-11-01

72/1008338376Grant: 2012-12-25 | Exp: 2032-12-20

72/10011129904Grant: 2021-09-28 | Exp: 2041-09-23

72/1007691804Grant: 2010-04-06 | Exp: 2030-04-01

72/10010428140Grant: 2019-10-01 | Exp: 2039-09-26

72/1006323027Grant: 2001-11-27 | Exp: 2021-11-22

72/1008475795Grant: 2013-07-02 | Exp: 2033-06-27

72/1008892364Grant: 2014-11-18 | Exp: 2034-11-13

72/1008173775Grant: 2012-05-08 | Exp: 2032-05-03

72/1007799902Grant: 2010-09-21 | Exp: 2030-09-16

72/1006521776Grant: 2003-02-18 | Exp: 2023-02-13

72/1008821883Grant: 2014-09-02 | Exp: 2034-08-28

72/1007674462Grant: 2010-03-09 | Exp: 2030-03-04

Formulation

(4)

85/1009522174Grant: 2016-12-20 | Exp: 2036-12-15

85/1008932574Grant: 2015-01-13 | Exp: 2035-01-08

75/1009452106Grant: 2016-09-27 | Exp: 2036-09-22

75/1008784399Grant: 2014-07-22 | Exp: 2034-07-17

Method of Use

(3)

82/10011884737Grant: 2024-01-30 | Exp: 2044-01-25

75/1008349324Grant: 2013-01-08 | Exp: 2033-01-03

72/1008828948Grant: 2014-09-09 | Exp: 2034-09-04

Manufacturing

(8)

82/1008709759Grant: 2014-04-29 | Exp: 2034-04-24

82/10010000544Grant: 2018-06-19 | Exp: 2038-06-14

75/10010563163Grant: 2020-02-18 | Exp: 2040-02-13

75/1009127043Grant: 2015-09-08 | Exp: 2035-09-03

75/1008608960Grant: 2013-12-17 | Exp: 2033-12-12

75/1008283138Grant: 2012-10-09 | Exp: 2032-10-04

72/10010793620Grant: 2020-10-06 | Exp: 2040-10-01

72/1009005926Grant: 2015-04-14 | Exp: 2035-04-09

Diagnostic

(1)

72/1009581604Grant: 2017-02-28 | Exp: 2037-02-23

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 761375

351(a) ReferenceLicensedCDERInjection

Proper Name

lecanemab-irmb

Applicant

Eisai, Incorporated

Approval Date

29-Aug-25

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 3, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — 360MG/1.8ML(200MG/ML)

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2025-08-29 00:00:00

No patent or exclusivity listings for this strength.