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BLA

ROZANOLIXIZUMAB-NOLI | B761286 | UCB INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 26, 2035(3280 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 26, 2035	Active	Computed
7-Year Orphan	Jun. 26, 1930	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Apr. 17, 20456863 days remaining

Based on latest discovered patent 12281330(manufacturing) · relevance 60/100

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

Discovered Patents

View all 42 patents →

42 AI-discovered patents, sorted by relevance.

Composition

(18)

85/1007355011Grant: 2008-04-08 | Exp: 2028-04-03

75/1009902768Grant: 2018-02-27 | Exp: 2038-02-22

72/1008329431Grant: 2012-12-11 | Exp: 2032-12-06

72/10010759844Grant: 2020-09-01 | Exp: 2040-08-27

72/1008986685Grant: 2015-03-24 | Exp: 2035-03-19

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

72/1008435761Grant: 2013-05-07 | Exp: 2033-05-02

72/1007105160Grant: 2006-09-12 | Exp: 2026-09-07

72/1008303953Grant: 2012-11-06 | Exp: 2032-11-01

68/1008053562Grant: 2011-11-08 | Exp: 2031-11-03

68/10010017575Grant: 2018-07-10 | Exp: 2038-07-05

65/1006509451Grant: 2003-01-21 | Exp: 2023-01-16

65/10010421816Grant: 2019-09-24 | Exp: 2039-09-19

65/1007989594Grant: 2011-08-02 | Exp: 2031-07-28

55/10012091450Grant: 2024-09-17 | Exp: 2044-09-12

55/1007919606Grant: 2011-04-05 | Exp: 2031-03-31

55/1007736635Grant: 2010-06-15 | Exp: 2030-06-10

55/1009321840Grant: 2016-04-26 | Exp: 2036-04-21

Formulation

(2)

55/1007910618Grant: 2011-03-22 | Exp: 2031-03-17

50/1006583301Grant: 2003-06-24 | Exp: 2023-06-19

Method of Use

(3)

75/10010799583Grant: 2020-10-13 | Exp: 2040-10-08

58/1007771969Grant: 2010-08-10 | Exp: 2030-08-05

55/1008304200Grant: 2012-11-06 | Exp: 2032-11-01

Manufacturing

(18)

75/1009315770Grant: 2016-04-19 | Exp: 2036-04-14

75/1007790414Grant: 2010-09-07 | Exp: 2030-09-02

75/1009399671Grant: 2016-07-26 | Exp: 2036-07-21

72/1008969038Grant: 2015-03-03 | Exp: 2035-02-26

72/1009476081Grant: 2016-10-25 | Exp: 2036-10-20

70/1009725516Grant: 2017-08-08 | Exp: 2037-08-03

65/1009951365Grant: 2018-04-24 | Exp: 2038-04-19

65/1009751930Grant: 2017-09-05 | Exp: 2037-08-31

65/1009315565Grant: 2016-04-19 | Exp: 2036-04-14

60/1008828719Grant: 2014-09-09 | Exp: 2034-09-04

60/1008969037Grant: 2015-03-03 | Exp: 2035-02-26

60/1007662609Grant: 2010-02-16 | Exp: 2030-02-11

60/1008969036Grant: 2015-03-03 | Exp: 2035-02-26

60/1009493558Grant: 2016-11-15 | Exp: 2036-11-10

60/10012281330Grant: 2025-04-22 | Exp: 2045-04-17

60/1009550973Grant: 2017-01-24 | Exp: 2037-01-19

55/1009493559Grant: 2016-11-15 | Exp: 2036-11-10

55/1006284488Grant: 2001-09-04 | Exp: 2021-08-30

Device

(1)

50/1008579866Grant: 2013-11-12 | Exp: 2033-11-07

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 761286 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

rozanolixizumab-noli

Applicant

UCB, Inc.

Approval Date

26-Jun-23

Orphan Exclusivity

26-Jun-30

Expired

Presentations

280MG/2ML (140MG/ML) — Single-Dose Vial (Subcutaneous)

420MG/3ML (140MG/ML) — Single-Dose Vial (Subcutaneous)

560MG/4ML (140MG/ML) — Single-Dose Vial (Subcutaneous)

840MG/6ML (140MG/ML) — Single-Dose Vial (Subcutaneous)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 10, 2025	SUPPL -7	View Letter (PDF)
Jun 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 280MG/2ML(140MG/ML)

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2023-06-26 00:00:00

No patent or exclusivity listings for this strength.