Viewing data from:

STARJEMZA

Interchangeable Biosimilar

USTEKINUMAB-HMNY | B761419 | BIO-THERA SOLUTIONS LTD

3 products0 Purple Book patents4 biosimilars

Biologic LOEBiosimilar competition

4 approved biosimilars

May 22, 2037(3976 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 22, 2037	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

StarjemzaBLA 761419ICStarjemzaBLA 761419ICStarjemzaBLA 761419ICStarjemzaBLA 761419IC

Discovered Patents

View all 189 patents →

Top 50 of 189 AI-discovered patents by relevance.

Composition

(34)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

75/1008921524Grant: 2014-12-30 | Exp: 2034-12-25

Formulation

(1)

75/1009631016Grant: 2017-04-25 | Exp: 2037-04-20

Method of Use

(11)

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

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

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

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

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

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

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

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

75/1009133439Grant: 2015-09-15 | Exp: 2035-09-10

Manufacturing

(4)

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

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

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 761419 | 4 presentations

InterchangeableLicensedCDERInjection

Proper Name

ustekinumab-hmny

Applicant

Bio-Thera Solutions, Ltd.

Approval Date

22-May-25

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)

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

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 27, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 45MG/0.5ML

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2025-05-22 00:00:00

No patent or exclusivity listings for this strength.

#002 — 130MG/26ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2025-05-22 00:00:00

#003 — 90MG/ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2025-05-22 00:00:00