Viewing data from:

OTULFI

Interchangeable Biosimilar

USTEKINUMAB-AAUZ | B761379 | FRESENIUS KABI USA

3 products0 Purple Book patents4 biosimilars

Biologic LOEBiosimilar competition

4 approved biosimilars

September 27, 2036(3739 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 27, 2036	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 17, 20456954 days remaining

Based on latest discovered patent 12365743(composition) · relevance 85/100

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

Approved Biosimilars

OtulfiBLA 761379ICOtulfiBLA 761379ICOtulfiBLA 761379ICOtulfiBLA 761379IC

Discovered Patents

View all 196 patents →

Top 50 of 196 AI-discovered patents by relevance.

Composition

(35)

95/1006835823Grant: 2004-12-28 | Exp: 2024-12-23

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

92/1009939452Grant: 2018-04-10 | Exp: 2038-04-05

92/1009676848Grant: 2017-06-13 | Exp: 2037-06-08

92/1007887807Grant: 2011-02-15 | Exp: 2031-02-10

92/1006790444Grant: 2004-09-14 | Exp: 2024-09-09

92/1007279157Grant: 2007-10-09 | Exp: 2027-10-04

92/10011359029Grant: 2022-06-14 | Exp: 2042-06-09

92/1007070775Grant: 2006-07-04 | Exp: 2026-06-29

90/1007160995Grant: 2007-01-09 | Exp: 2027-01-04

90/1008084233Grant: 2011-12-27 | Exp: 2031-12-22

88/1009850310Grant: 2017-12-26 | Exp: 2037-12-21

88/10011236155Grant: 2022-02-01 | Exp: 2042-01-27

88/1007101674Grant: 2006-09-05 | Exp: 2026-08-31

85/1007179893Grant: 2007-02-20 | Exp: 2027-02-15

85/1006902734Grant: 2005-06-07 | Exp: 2025-06-02

85/10012365743Grant: 2025-07-22 | Exp: 2045-07-17

85/10012065488Grant: 2024-08-20 | Exp: 2044-08-15

85/1008415291Grant: 2013-04-09 | Exp: 2033-04-04

85/1008703141Grant: 2014-04-22 | Exp: 2034-04-17

85/1007560247Grant: 2009-07-14 | Exp: 2029-07-09

85/10011725194Grant: 2023-08-15 | Exp: 2043-08-10

85/1008617894Grant: 2013-12-31 | Exp: 2033-12-26

85/10010562968Grant: 2020-02-18 | Exp: 2040-02-13

85/10011365244Grant: 2022-06-21 | Exp: 2042-06-16

85/10011149094Grant: 2021-10-19 | Exp: 2041-10-14

85/10010934328Grant: 2021-03-02 | Exp: 2041-02-25

82/10012077592Grant: 2024-09-03 | Exp: 2044-08-29

80/10011096998Grant: 2021-08-24 | Exp: 2041-08-19

80/10011844766Grant: 2023-12-19 | Exp: 2043-12-14

78/1009750801Grant: 2017-09-05 | Exp: 2037-08-31

75/10010179812Grant: 2019-01-15 | Exp: 2039-01-10

75/1007163681Grant: 2007-01-16 | Exp: 2027-01-11

75/10010519223Grant: 2019-12-31 | Exp: 2039-12-26

75/10012331076Grant: 2025-06-17 | Exp: 2045-06-12

Method of Use

(10)

95/1007416729Grant: 2008-08-26 | Exp: 2028-08-21

92/1007166284Grant: 2007-01-23 | Exp: 2027-01-18

92/10010519231Grant: 2019-12-31 | Exp: 2039-12-26

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

92/1007179466Grant: 2007-02-20 | Exp: 2027-02-15

85/10011078267Grant: 2021-08-03 | Exp: 2041-07-29

85/10010259867Grant: 2019-04-16 | Exp: 2039-04-11

85/1008329171Grant: 2012-12-11 | Exp: 2032-12-06

85/1007160542Grant: 2007-01-09 | Exp: 2027-01-04

82/1009593310Grant: 2017-03-14 | Exp: 2037-03-09

Manufacturing

(5)

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

85/1009752125Grant: 2017-09-05 | Exp: 2037-08-31

85/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

78/1008361474Grant: 2013-01-29 | Exp: 2033-01-24

75/10011692007Grant: 2023-07-04 | Exp: 2043-06-29

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 761379 | 4 presentations

InterchangeableLicensedCDERInjection

Proper Name

ustekinumab-aauz

Applicant

Fresenius Kabi USA, LLC

Approval Date

27-Sep-24

Reference Product: Stelara — ustekinumab

Presentations

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

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

130MG/26ML (5MG/ML) — Single-Dose Vial (Intravenous)

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

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2026	SUPPL -9	View Letter (PDF)
Aug 18, 2025	SUPPL -6	View Letter (PDF)
Aug 18, 2025	SUPPL -7	View Letter (PDF)
May 5, 2025	SUPPL -4	View Letter (PDF)
May 5, 2025	ORIG -2	View Letter (PDF)
Apr 21, 2025	SUPPL -1	View Letter (PDF)
Mar 25, 2025	SUPPL -2	View Letter (PDF)
Feb 21, 2025	SUPPL -3	View Letter (PDF)
Sep 30, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 45MG/0.5ML

▴

INJECTABLE;INJECTION | Approved: 2024-09-27 00:00:00

No patent or exclusivity listings for this strength.

#002 — 90MG/1ML

▾

INJECTABLE;INJECTION | Approved: 2024-09-27 00:00:00

#003 — 130MG/26ML

▾

INJECTABLE;INJECTION | Approved: 2024-09-27 00:00:00