Viewing data from:

WEZLANA

Interchangeable Biosimilar

USTEKINUMAB-AUUB | B761285 | AMGEN INC

2 products0 Purple Book patents5 biosimilars

Biologic LOEBiosimilar competition

5 approved biosimilars

October 31, 2035(3407 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Oct. 31, 2035	Active	Computed
1-Year Interchangeable	Apr. 30, 2025	Expired	Purple Book

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

WezlanaBLA 761285ICWezlanaBLA 761285ICWezlanaBLA 761285ICWezlanaBLA 761285WezlanaBLA 761285

Discovered Patents

View all 444 patents →

Top 50 of 444 AI-discovered patents by relevance.

Composition

(36)

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

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

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

92/1009340621Grant: 2016-05-17 | Exp: 2036-05-12

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

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

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

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

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

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

90/10012281176Grant: 2025-04-22 | Exp: 2045-04-17

90/10011891435Grant: 2024-02-06 | Exp: 2044-02-01

90/1006271346Grant: 2001-08-07 | Exp: 2021-08-02

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

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

88/1007247711Grant: 2007-07-24 | Exp: 2027-07-19

88/1008604174Grant: 2013-12-10 | Exp: 2033-12-05

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

85/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

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

85/1006221675Grant: 2001-04-24 | Exp: 2021-04-19

85/10010597456Grant: 2020-03-24 | Exp: 2040-03-19

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

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

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

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

85/10011059908Grant: 2021-07-13 | Exp: 2041-07-08

85/1006417158Grant: 2002-07-09 | Exp: 2022-07-04

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

85/1007282483Grant: 2007-10-16 | Exp: 2027-10-11

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

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

85/10010829551Grant: 2020-11-10 | Exp: 2040-11-05

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

Formulation

(1)

85/10010808033Grant: 2020-10-20 | Exp: 2040-10-15

Method of Use

(9)

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

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

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

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

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

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

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

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

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

Manufacturing

(4)

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

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

85/1007238776Grant: 2007-07-03 | Exp: 2027-06-28

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

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 761285 | 5 presentations

InterchangeableLicensedCDERInjection

Proper Name

ustekinumab-auub

Applicant

Amgen Inc.

Approval Date

31-Oct-23

Reference Product: Stelara — ustekinumab

Presentations

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

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

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

45MG/0.5ML — Autoinjector (Subcutaneous)

90MG/ML — Autoinjector (Subcutaneous)

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 13, 2026	SUPPL -6	View Letter (PDF)
Sep 26, 2025	SUPPL -4	View Letter (PDF)
Dec 27, 2024	SUPPL -1	View Letter (PDF)
Dec 18, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 45MG/0.5ML

▴

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: 2023-10-31 00:00:00

No patent or exclusivity listings for this strength.

#002 — 90MG/ML

▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: 2023-10-31 00:00:00