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BLA

USTEKINUMAB | B125261 | CENTOCOR ORTHO BIOTECH INC

2 products6 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

September 24, 2039(4831 days remaining)

Purple Book Patents (6)

Patent	Expiration	Status
6902734	Sep. 25, 2023	Expired
8852889	Jul. 6, 2032	Active
9217168	Mar. 14, 2033	Active
9475858	Jul. 6, 2032	Active
9663810	Mar. 14, 2033	Active
10961307	Sep. 24, 2039	Active

Discovered Patents

View all 52 patents →

Top 50 of 52 AI-discovered patents by relevance.

Composition

(23)

95/1007166285Grant: 2007-01-23 | Exp: 2027-01-18

95/1008703141Grant: 2014-04-22 | Exp: 2034-04-17

95/1007279157Grant: 2007-10-09 | Exp: 2027-10-04

95/1007560247Grant: 2009-07-14 | Exp: 2029-07-09

95/1006902734Grant: 2005-06-07 | Exp: 2025-06-02

95/1007887807Grant: 2011-02-15 | Exp: 2031-02-10

92/1008084233Grant: 2011-12-27 | Exp: 2031-12-22

90/1009676848Grant: 2017-06-13 | Exp: 2037-06-08

87/10011952417Grant: 2024-04-09 | Exp: 2044-04-04

85/10012018057Grant: 2024-06-25 | Exp: 2044-06-20

75/10011845808Grant: 2023-12-19 | Exp: 2043-12-14

72/10010947288Grant: 2021-03-16 | Exp: 2041-03-11

72/10011939361Grant: 2024-03-26 | Exp: 2044-03-21

65/1009732135Grant: 2017-08-15 | Exp: 2037-08-10

65/1009850310Grant: 2017-12-26 | Exp: 2037-12-21

55/10010899833Grant: 2021-01-26 | Exp: 2041-01-21

55/10012291797Grant: 2025-05-06 | Exp: 2045-05-01

52/1009062120Grant: 2015-06-23 | Exp: 2035-06-18

50/10011149094Grant: 2021-10-19 | Exp: 2041-10-14

50/10010053513Grant: 2018-08-21 | Exp: 2038-08-16

50/10011078263Grant: 2021-08-03 | Exp: 2041-07-29

50/10011466082Grant: 2022-10-11 | Exp: 2042-10-06

50/1008975040Grant: 2015-03-10 | Exp: 2035-03-05

Formulation

(2)

55/10012303483Grant: 2025-05-20 | Exp: 2045-05-15

50/1008318164Grant: 2012-11-27 | Exp: 2032-11-22

Method of Use

(13)

95/10011078267Grant: 2021-08-03 | Exp: 2041-07-29

95/10010519231Grant: 2019-12-31 | Exp: 2039-12-26

95/10012091452Grant: 2024-09-17 | Exp: 2044-09-12

92/1008329171Grant: 2012-12-11 | Exp: 2032-12-06

92/10011578124Grant: 2023-02-14 | Exp: 2043-02-09

92/10010961307Grant: 2021-03-30 | Exp: 2041-03-25

92/1009409984Grant: 2016-08-09 | Exp: 2036-08-04

90/10010259867Grant: 2019-04-16 | Exp: 2039-04-11

88/10011208474Grant: 2021-12-28 | Exp: 2041-12-23

88/10011197913Grant: 2021-12-14 | Exp: 2041-12-09

85/10010765724Grant: 2020-09-08 | Exp: 2040-09-03

70/1008580714Grant: 2013-11-12 | Exp: 2033-11-07

68/10012404324Grant: 2025-09-02 | Exp: 2045-08-28

Manufacturing

(9)

92/10011079361Grant: 2021-08-03 | Exp: 2041-07-29

92/10012234283Grant: 2025-02-25 | Exp: 2045-02-20

85/1007736650Grant: 2010-06-15 | Exp: 2030-06-10

85/1008361474Grant: 2013-01-29 | Exp: 2033-01-24

70/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

55/10012084475Grant: 2024-09-10 | Exp: 2044-09-05

55/1008980626Grant: 2015-03-17 | Exp: 2035-03-12

55/1008017325Grant: 2011-09-13 | Exp: 2031-09-08

50/1007498150Grant: 2009-03-03 | Exp: 2029-02-26

Diagnostic

(3)

88/10012379368Grant: 2025-08-05 | Exp: 2045-07-31

78/1008557745Grant: 2013-10-15 | Exp: 2033-10-10

72/10011180565Grant: 2021-11-23 | Exp: 2041-11-18

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2023-01103	10961307	IPR	Samsung Bioepis Co., Ltd.	Terminated-Settled	2023-06-21	2023-08-09
IPR2023-01444	10961307	IPR	Biocon Biologics Inc. et al.	Terminated-Settled	2023-11-22	2024-03-04

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Janssen Biotech, Inc. v. Amgen Inc. 1:2022cv01549 2 patentsustekinumab	D. Del.	2022-11-29	Terminated 2023-05-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 125261 | 4 presentations | 6 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

ustekinumab

Applicant

Janssen Biotech, Inc.

Approval Date

25-Sep-09

Listed Patents

Patent Number	Expiration
6902734	September 25, 2023
8852889	July 6, 2032
9217168	March 14, 2033
9475858	July 6, 2032
9663810	March 14, 2033
10961307	September 24, 2039

Presentations

45MG/0.5ML — Single-Dose Vial (Subcutaneous)

90MG/ML — Single-Dose Vial (Subcutaneous)

45MG/0.5ML — Pre-Filled Syringe (Subcutaneous)

90MG/ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

29 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2026	SUPPL -172	View Letter (PDF)
Nov 4, 2025	SUPPL -171	View Letter (PDF)
Jun 30, 2025	SUPPL -167	View Letter (PDF)
Apr 8, 2025	SUPPL -168	View Letter (PDF)
Nov 19, 2024	SUPPL -166	View Letter (PDF)
Mar 19, 2024	SUPPL -163	View Letter (PDF)
Mar 7, 2023	SUPPL -158	View Letter (PDF)
Aug 1, 2022	SUPPL -161	View Letter (PDF)
Dec 15, 2020	SUPPL -157	View Letter (PDF)
Dec 2, 2020	SUPPL -154	View Letter (PDF)
Jul 30, 2020	SUPPL -150	View Letter (PDF)
Nov 12, 2019	SUPPL -142	View Letter (PDF)
Oct 24, 2019	SUPPL -152	View Letter (PDF)
Jun 14, 2018	SUPPL -147	View Letter (PDF)
Feb 23, 2018	SUPPL -141	View Letter (PDF)
Oct 18, 2017	SUPPL -138	View Letter (PDF)
Apr 27, 2017	SUPPL -129	View Letter (PDF)
Mar 6, 2014	SUPPL -114	View Letter (PDF)
Sep 23, 2013	SUPPL -103	View Letter (PDF)
May 23, 2013	SUPPL -86	View Letter (PDF)
May 1, 2013	SUPPL -99	View Letter (PDF)
Jan 30, 2013	SUPPL -91	View Letter (PDF)
Jun 15, 2012	SUPPL -59	View Letter (PDF)
Jun 4, 2012	SUPPL -49	View Letter (PDF)
May 4, 2012	SUPPL -63	View Letter (PDF)
Apr 11, 2012	SUPPL -58	View Letter (PDF)
Dec 28, 2010	SUPPL -13	View Letter (PDF)
Jan 27, 2010	SUPPL -1	View Letter (PDF)
Oct 5, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 45MG/0.5ML

▴

INJECTABLE; INJECTION | Approved: 2009-09-25 00:00:00

No patent or exclusivity listings for this strength.

#002 — 90MG/1ML

▾

INJECTABLE; INJECTION | Approved: 2009-09-25 00:00:00