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BIMZELX

BLA

BIMEKIZUMAB-BKZX | B761151 | UCB INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

October 17, 2035(3393 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Oct. 17, 2035	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Apr. 19, 20384308 days remaining

Based on latest discovered patent 9951365(manufacturing) · relevance 55/100

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

Discovered Patents

View all 15 patents →

15 AI-discovered patents, sorted by relevance.

Composition

(4)

95/1008303953Grant: 2012-11-06 | Exp: 2032-11-01

95/1008435761Grant: 2013-05-07 | Exp: 2033-05-02

85/1008329431Grant: 2012-12-11 | Exp: 2032-12-06

50/1009045529Grant: 2015-06-02 | Exp: 2035-05-28

Manufacturing

(11)

60/1009315565Grant: 2016-04-19 | Exp: 2036-04-14

55/1009476081Grant: 2016-10-25 | Exp: 2036-10-20

55/1009951365Grant: 2018-04-24 | Exp: 2038-04-19

55/1008828719Grant: 2014-09-09 | Exp: 2034-09-04

55/1007662609Grant: 2010-02-16 | Exp: 2030-02-11

50/1009399671Grant: 2016-07-26 | Exp: 2036-07-21

50/1008969038Grant: 2015-03-03 | Exp: 2035-02-26

50/1006284488Grant: 2001-09-04 | Exp: 2021-08-30

50/1009493559Grant: 2016-11-15 | Exp: 2036-11-10

50/1009315770Grant: 2016-04-19 | Exp: 2036-04-14

50/1008969036Grant: 2015-03-03 | Exp: 2035-02-26

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 761151 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

bimekizumab-bkzx

Applicant

UCB, Inc.

Approval Date

17-Oct-23

Presentations

160MG/ML — Pre-Filled Syringe (Subcutaneous)

160MG/ML — Autoinjector (Subcutaneous)

320MG/2ML (160MG/2ML) — Pre-Filled Syringe (Subcutaneous)

320MG/2ML (160MG/2ML) — Autoinjector (Subcutaneous)

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Nov 21, 2024	SUPPL -10	View Letter (PDF)
Oct 15, 2024	SUPPL -9	View Letter (PDF)
Sep 24, 2024	SUPPL -5	View Letter (PDF)
Sep 24, 2024	SUPPL -6	View Letter (PDF)
Sep 24, 2024	SUPPL -7	View Letter (PDF)
Oct 19, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 160ML

▴

INJECTABLE;INJECTION | Approved: 2023-10-17 00:00:00

No patent or exclusivity listings for this strength.