Viewing data from:

AVTOZMA

Interchangeable Biosimilar

TOCILIZUMAB-ANOH | B761420 | CELLTRION INC

4 products0 Purple Book patents9 biosimilars

Biologic LOEBiosimilar competition

9 approved biosimilars

January 24, 2037(3858 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 24, 2037	Active	Computed
1-Year Interchangeable	Jul. 24, 2026	Active	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 18, 20457017 days remaining

Based on latest discovered patent 12421299(manufacturing) · relevance 85/100

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

Approved Biosimilars

AvtozmaBLA 761420ICAvtozmaBLA 761420ICAvtozmaBLA 761420ICAvtozmaBLA 761420ICAvtozmaBLA 761420ICAvtozmaBLA 761420ICAvtozmaBLA 761420ICAvtozmaBLA 761420ICAvtozmaBLA 761420

Discovered Patents

View all 787 patents →

Top 50 of 787 AI-discovered patents by relevance.

Composition

(35)

95/1009273113Grant: 2016-03-01 | Exp: 2036-02-25

92/1009815869Grant: 2017-11-14 | Exp: 2037-11-09

92/10011407794Grant: 2022-08-09 | Exp: 2042-08-04

90/1008252287Grant: 2012-08-28 | Exp: 2032-08-23

88/1008163522Grant: 2012-04-24 | Exp: 2032-04-19

88/10011530275Grant: 2022-12-20 | Exp: 2042-12-15

88/1006686455Grant: 2004-02-03 | Exp: 2024-01-29

85/10010844113Grant: 2020-11-24 | Exp: 2040-11-19

85/1008617556Grant: 2013-12-31 | Exp: 2033-12-26

85/10010287352Grant: 2019-05-14 | Exp: 2039-05-09

85/1006870033Grant: 2005-03-22 | Exp: 2025-03-17

85/10011466087Grant: 2022-10-11 | Exp: 2042-10-06

85/1007449551Grant: 2008-11-11 | Exp: 2028-11-06

85/1008268313Grant: 2012-09-18 | Exp: 2032-09-13

85/1006911321Grant: 2005-06-28 | Exp: 2025-06-23

85/10012023378Grant: 2024-07-02 | Exp: 2044-06-27

85/1009926379Grant: 2018-03-27 | Exp: 2038-03-22

85/1006583272Grant: 2003-06-24 | Exp: 2023-06-19

85/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

85/10010696721Grant: 2020-06-30 | Exp: 2040-06-25

85/1007201897Grant: 2007-04-10 | Exp: 2027-04-05

85/10010450381Grant: 2019-10-22 | Exp: 2039-10-17

85/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

85/10010358465Grant: 2019-07-23 | Exp: 2039-07-18

85/1007318918Grant: 2008-01-15 | Exp: 2028-01-10

85/10011285207Grant: 2022-03-29 | Exp: 2042-03-24

85/10011827717Grant: 2023-11-28 | Exp: 2043-11-23

85/1007427596Grant: 2008-09-23 | Exp: 2028-09-18

85/10010808028Grant: 2020-10-20 | Exp: 2040-10-15

85/1009334331Grant: 2016-05-10 | Exp: 2036-05-05

85/1008722859Grant: 2014-05-13 | Exp: 2034-05-08

85/1007291708Grant: 2007-11-06 | Exp: 2027-11-01

85/10011111311Grant: 2021-09-07 | Exp: 2041-09-02

85/1008563683Grant: 2013-10-22 | Exp: 2033-10-17

85/10011242390Grant: 2022-02-08 | Exp: 2042-02-03

Method of Use

(3)

88/1006723319Grant: 2004-04-20 | Exp: 2024-04-15

88/1007824674Grant: 2010-11-02 | Exp: 2030-10-28

85/1008802092Grant: 2014-08-12 | Exp: 2034-08-07

Manufacturing

(9)

88/1007662934Grant: 2010-02-16 | Exp: 2030-02-11

88/1009631007Grant: 2017-04-25 | Exp: 2037-04-20

85/10012421299Grant: 2025-09-23 | Exp: 2045-09-18

85/10010975168Grant: 2021-04-13 | Exp: 2041-04-08

85/10011370838Grant: 2022-06-28 | Exp: 2042-06-23

85/1006555373Grant: 2003-04-29 | Exp: 2023-04-24

85/10011976127Grant: 2024-05-07 | Exp: 2044-05-02

85/1008884096Grant: 2014-11-11 | Exp: 2034-11-06

85/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

Device

(1)

85/1008118782Grant: 2012-02-21 | Exp: 2032-02-16

Diagnostic

(2)

85/10012174184Grant: 2024-12-24 | Exp: 2044-12-19

85/10011221324Grant: 2022-01-11 | Exp: 2042-01-06

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 761420 | 9 presentations

InterchangeableLicensedCDERInjection

Proper Name

tocilizumab-anoh

Applicant

CELLTRION, Inc.

Approval Date

24-Jan-25

Reference Product: Actemra — tocilizumab

Presentations

80MG/4ML (20MG/ML) — Single-Dose Vial (Intravenous)

200MG/10ML (20MG/ML) — Single-Dose Vial (Intravenous)

400MG/20ML (20MG/ML) — Single-Dose Vial (Intravenous)

162MG/0.9ML — Pre-Filled Syringe (Subcutaneous)

162MG/0.9ML — Autoinjector (Subcutaneous)

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 15, 2026	SUPPL -5	View Letter (PDF)
Jul 31, 2025	SUPPL -1	View Letter (PDF)
Feb 7, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG/4ML(20MG/ML)

▴

INJECTABLE;INTRAVENOUS | Approved: 2025-01-24 00:00:00

No patent or exclusivity listings for this strength.

#002 — 200MG/10ML(20MG/ML)

▾

INJECTABLE;INTRAVENOUS | Approved: 2025-01-24 00:00:00

#003 — 400MG/20ML(20MG/ML)

▾

INJECTABLE;INTRAVENOUS | Approved: 2025-01-24 00:00:00

#004 — 162MG/0.9ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2025-01-24 00:00:00