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BLA

DEPEMOKIMAB-ULAA | B761458 | GLAXOSMITHKLINE LLC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 16, 2037(4184 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 16, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 10, 20456947 days remaining

Based on latest discovered patent 12358945(manufacturing) · relevance 72/100

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

Discovered Patents

View all 134 patents →

Top 50 of 134 AI-discovered patents by relevance.

Composition

(39)

92/1007943741Grant: 2011-05-17 | Exp: 2031-05-12

90/1006797273Grant: 2004-09-28 | Exp: 2024-09-23

88/1007416846Grant: 2008-08-26 | Exp: 2028-08-21

85/1007758866Grant: 2010-07-20 | Exp: 2030-07-15

85/1009011869Grant: 2015-04-21 | Exp: 2035-04-16

85/1006770284Grant: 2004-08-03 | Exp: 2024-07-29

85/1007205125Grant: 2007-04-17 | Exp: 2027-04-12

85/1006872568Grant: 2005-03-29 | Exp: 2025-03-24

85/1007662399Grant: 2010-02-16 | Exp: 2030-02-11

85/1006506362Grant: 2003-01-14 | Exp: 2023-01-09

85/1009067987Grant: 2015-06-30 | Exp: 2035-06-25

85/1006709657Grant: 2004-03-23 | Exp: 2024-03-18

82/1009265821Grant: 2016-02-23 | Exp: 2036-02-18

82/1009365624Grant: 2016-06-14 | Exp: 2036-06-09

78/1007858753Grant: 2010-12-28 | Exp: 2030-12-23

75/1007238660Grant: 2007-07-03 | Exp: 2027-06-28

75/1007815915Grant: 2010-10-19 | Exp: 2030-10-14

75/1009056075Grant: 2015-06-16 | Exp: 2035-06-11

75/1006391299Grant: 2002-05-21 | Exp: 2022-05-16

75/1007217419Grant: 2007-05-15 | Exp: 2027-05-10

75/1007858098Grant: 2010-12-28 | Exp: 2030-12-23

75/10011427643Grant: 2022-08-30 | Exp: 2042-08-25

72/1007601351Grant: 2009-10-13 | Exp: 2029-10-08

72/1006800729Grant: 2004-10-05 | Exp: 2024-09-30

72/1008541007Grant: 2013-09-24 | Exp: 2033-09-19

72/1007338934Grant: 2008-03-04 | Exp: 2028-02-28

72/1006936698Grant: 2005-08-30 | Exp: 2025-08-25

72/1008846080Grant: 2014-09-30 | Exp: 2034-09-25

72/1006410286Grant: 2002-06-25 | Exp: 2022-06-20

72/10011291635Grant: 2022-04-05 | Exp: 2042-03-31

72/1008003386Grant: 2011-08-23 | Exp: 2031-08-18

72/1008309096Grant: 2012-11-13 | Exp: 2032-11-08

72/1006680171Grant: 2004-01-20 | Exp: 2024-01-15

72/1007393943Grant: 2008-07-01 | Exp: 2028-06-26

72/1007399593Grant: 2008-07-15 | Exp: 2028-07-10

72/1006994860Grant: 2006-02-07 | Exp: 2026-02-02

70/10012076385Grant: 2024-09-03 | Exp: 2044-08-29

70/1007166287Grant: 2007-01-23 | Exp: 2027-01-18

70/1007708996Grant: 2010-05-04 | Exp: 2030-04-29

Method of Use

(4)

92/10011401334Grant: 2022-08-02 | Exp: 2042-07-28

85/1008202837Grant: 2012-06-19 | Exp: 2032-06-14

72/1006346388Grant: 2002-02-12 | Exp: 2022-02-07

70/10012234293Grant: 2025-02-25 | Exp: 2045-02-20

Manufacturing

(7)

75/1007132262Grant: 2006-11-07 | Exp: 2026-11-02

75/10011530238Grant: 2022-12-20 | Exp: 2042-12-15

72/10012358945Grant: 2025-07-15 | Exp: 2045-07-10

70/10010676503Grant: 2020-06-09 | Exp: 2040-06-04

70/10011667887Grant: 2023-06-06 | Exp: 2043-06-01

70/1009534246Grant: 2017-01-03 | Exp: 2036-12-29

70/1008858955Grant: 2014-10-14 | Exp: 2034-10-09

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 761458 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

depemokimab-ulaa

Applicant

GlaxoSmithKline LLC

Approval Date

16-Dec-25

Presentations

100MG/ML — Autoinjector (Subcutaneous)

100MG/ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 11, 2026	SUPPL -2	View Letter (PDF)
Dec 19, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

▴

INJECTION | Approved: 2025-12-16 00:00:00

No patent or exclusivity listings for this strength.