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CIMZIA

BLA

CERTOLIZUMAB PEGOL | B125160 | UCB INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

March 28, 2031(1729 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 28, 2031	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 14, 20436373 days remaining

Based on latest discovered patent 11844839(manufacturing) · relevance 65/100

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

Discovered Patents

View all 36 patents →

36 AI-discovered patents, sorted by relevance.

Composition

(12)

72/1009045529Grant: 2015-06-02 | Exp: 2035-05-28

70/1007989594Grant: 2011-08-02 | Exp: 2031-07-28

65/1007736635Grant: 2010-06-15 | Exp: 2030-06-10

60/1007105160Grant: 2006-09-12 | Exp: 2026-09-07

55/10011578428Grant: 2023-02-14 | Exp: 2043-02-09

55/1008053562Grant: 2011-11-08 | Exp: 2031-11-03

55/1009902768Grant: 2018-02-27 | Exp: 2038-02-22

52/10010759844Grant: 2020-09-01 | Exp: 2040-08-27

50/10010647756Grant: 2020-05-12 | Exp: 2040-05-07

50/1008067546Grant: 2011-11-29 | Exp: 2031-11-24

50/1009526798Grant: 2016-12-27 | Exp: 2036-12-22

50/10010941216Grant: 2021-03-09 | Exp: 2041-03-04

Formulation

(4)

55/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

50/1007910618Grant: 2011-03-22 | Exp: 2031-03-17

50/1007758860Grant: 2010-07-20 | Exp: 2030-07-15

50/10010188600Grant: 2019-01-29 | Exp: 2039-01-24

Method of Use

(1)

90/10010918737Grant: 2021-02-16 | Exp: 2041-02-11

Manufacturing

(18)

68/10011339214Grant: 2022-05-24 | Exp: 2042-05-19

65/1009550973Grant: 2017-01-24 | Exp: 2037-01-19

65/1009309280Grant: 2016-04-12 | Exp: 2036-04-07

65/10011844839Grant: 2023-12-19 | Exp: 2043-12-14

55/1009469672Grant: 2016-10-18 | Exp: 2036-10-13

55/1007514237Grant: 2009-04-07 | Exp: 2029-04-02

55/1008574907Grant: 2013-11-05 | Exp: 2033-10-31

50/1009951365Grant: 2018-04-24 | Exp: 2038-04-19

50/1009476081Grant: 2016-10-25 | Exp: 2036-10-20

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

50/10010189897Grant: 2019-01-29 | Exp: 2039-01-24

50/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

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

50/1009279000Grant: 2016-03-08 | Exp: 2036-03-03

50/10011661438Grant: 2023-05-30 | Exp: 2043-05-25

50/1009822143Grant: 2017-11-21 | Exp: 2037-11-16

50/10010443035Grant: 2019-10-15 | Exp: 2039-10-10

50/1009816069Grant: 2017-11-14 | Exp: 2037-11-09

Diagnostic

(1)

75/10011779643Grant: 2023-10-10 | Exp: 2043-10-05

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 125160 | 2 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

certolizumab pegol

Applicant

UCB, Inc.

Approval Date

22-Apr-08

Presentations

200MG — Single-Dose Vial (Subcutaneous)

200MG/ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

27 letters from Drugs@FDA

Date	Submission	Document
Sep 24, 2025	SUPPL -315	View Letter (PDF)
Sep 16, 2024	SUPPL -275	View Letter (PDF)
Nov 14, 2023	SUPPL -309	View Letter (PDF)
Dec 23, 2022	SUPPL -305	View Letter (PDF)
Sep 9, 2019	SUPPL -293	View Letter (PDF)
Mar 29, 2019	SUPPL -237	View Letter (PDF)
Feb 28, 2019	SUPPL -289	View Letter (PDF)
May 29, 2018	SUPPL -283	View Letter (PDF)
Mar 28, 2018	SUPPL -281	View Letter (PDF)
Jan 5, 2017	SUPPL -270	View Letter (PDF)
May 4, 2016	SUPPL -241	View Letter (PDF)
Feb 4, 2016	SUPPL -268	View Letter (PDF)
Oct 21, 2015	SUPPL -264	View Letter (PDF)
Oct 18, 2013	SUPPL -215	View Letter (PDF)
Oct 1, 2013	SUPPL -213	View Letter (PDF)
Nov 16, 2012	SUPPL -189	View Letter (PDF)
Oct 10, 2012	SUPPL -192	View Letter (PDF)
Oct 10, 2012	SUPPL -186	View Letter (PDF)
Aug 31, 2012	SUPPL -180	View Letter (PDF)
Aug 6, 2012	SUPPL -142	View Letter (PDF)
Apr 23, 2012	SUPPL -174	View Letter (PDF)
Sep 13, 2011	SUPPL -157	View Letter (PDF)
Nov 4, 2010	SUPPL -126	View Letter (PDF)
Aug 2, 2010	SUPPL -111	View Letter (PDF)
Dec 2, 2009	SUPPL -92	View Letter (PDF)
Jan 30, 2009	SUPPL -38	View Letter (PDF)
Apr 30, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

▴

INJECTABLE; INJECTION | Approved: 2008-04-22 00:00:00

No patent or exclusivity listings for this strength.