Viewing data from:

IMULDOSA

Biosimilar

USTEKINUMAB-SRLF | B761364 | ACCORD BIOPHARMA INC.

3 products0 Purple Book patents3 biosimilars

Biologic LOEBiosimilar competition

3 approved biosimilars

October 10, 2036(3752 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Oct. 10, 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

ImuldosaBLA 761364ImuldosaBLA 761364ImuldosaBLA 761364

Discovered Patents

View all 189 patents →

Top 50 of 189 AI-discovered patents by relevance.

Composition

(33)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

75/10011498944Grant: 2022-11-15 | Exp: 2042-11-10

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

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

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

Manufacturing

(4)

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

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

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

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

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 761364 | 3 presentations

BiosimilarLicensedCDERInjection

Proper Name

ustekinumab-srlf

Applicant

Accord BioPharma Inc.

Approval Date

10-Oct-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)

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2026	SUPPL -5	View Letter (PDF)
Nov 21, 2025	SUPPL -3	View Letter (PDF)
Mar 18, 2025	SUPPL -1	View Letter (PDF)
Oct 15, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 45MG/0.5ML

▴

INJECTABLE;INTRAVENOUS | Approved: 2024-10-10 00:00:00

No patent or exclusivity listings for this strength.

#002 — 90MG/ML

▾

INJECTABLE;INTRAVENOUS | Approved: 2024-10-10 00:00:00

#003 — 130MG/26ML

▾

INJECTABLE;INTRAVENOUS | Approved: 2024-10-10 00:00:00