Viewing data from:

SELARSDI

Interchangeable Biosimilar

USTEKINUMAB-AEKN | B761343 | ALVOTECH USA INC

2 products0 Purple Book patents4 biosimilars

Biologic LOEBiosimilar competition

4 approved biosimilars

April 16, 2036(3575 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Apr. 16, 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

SelarsdiBLA 761343ICSelarsdiBLA 761343ICSelarsdiBLA 761343ICSelarsdiBLA 761343IC

Discovered Patents

View all 190 patents →

Top 50 of 190 AI-discovered patents by relevance.

Composition

(32)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Formulation

(1)

75/10012303483Grant: 2025-05-20 | Exp: 2045-05-15

Method of Use

(12)

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

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

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

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

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

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

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

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

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

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

75/10010076544Grant: 2018-09-18 | Exp: 2038-09-13

75/1008277809Grant: 2012-10-02 | Exp: 2032-09-27

Manufacturing

(4)

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

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

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

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

Diagnostic

(1)

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

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 761343 | 4 presentations

InterchangeableLicensedCDERInjection

Proper Name

ustekinumab-aekn

Applicant

Alvotech USA Inc.

Approval Date

16-Apr-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

8 letters from Drugs@FDA

Date	Submission	Document
Dec 2, 2025	SUPPL -13	View Letter (PDF)
Nov 21, 2025	SUPPL -12	View Letter (PDF)
May 5, 2025	SUPPL -4	View Letter (PDF)
Mar 19, 2025	SUPPL -5	View Letter (PDF)
Oct 22, 2024	SUPPL -2	View Letter (PDF)
Oct 21, 2024	SUPPL -3	View Letter (PDF)
Oct 21, 2024	SUPPL -1	View Letter (PDF)
Apr 17, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 45MG/0.5ML

▴

INJECTABLE;INJECTION | Approved: 2024-04-16 00:00:00

No patent or exclusivity listings for this strength.

#002 — 90MG/ML

▾

INJECTABLE;INJECTION | Approved: 2024-04-16 00:00:00