Viewing data from:

TOFIDENCE

Biosimilar

TOCILIZUMAB-BAVI | B761354 | BIOGEN MA

3 products0 Purple Book patents3 biosimilars

Biologic LOEBiosimilar competition

3 approved biosimilars

September 29, 2035(3375 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 29, 2035	Active	Computed

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

TofidenceBLA 761354TofidenceBLA 761354TofidenceBLA 761354

Discovered Patents

View all 785 patents →

Top 50 of 785 AI-discovered patents by relevance.

Composition

(37)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

82/10011192957Grant: 2021-12-07 | Exp: 2041-12-02

82/1006271362Grant: 2001-08-07 | Exp: 2021-08-02

Method of Use

(1)

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

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

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

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

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

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

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

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 761354 | 3 presentations

BiosimilarLicensedCDERInjection

Proper Name

tocilizumab-bavi

Applicant

Biogen MA Inc.

Approval Date

29-Sep-23

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)

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
May 27, 2026	SUPPL -9	View Letter (PDF)
Mar 7, 2025	SUPPL -5	View Letter (PDF)
Dec 4, 2024	SUPPL -4	View Letter (PDF)
Jul 23, 2024	SUPPL -2	View Letter (PDF)
Oct 3, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 80MG/4ML

▴

INJECTABLE;INJECTION | Approved: 2023-09-29 00:00:00

No patent or exclusivity listings for this strength.

#002 — 200MG/10ML

▾

INJECTABLE;INJECTION | Approved: 2023-09-29 00:00:00

#003 — 400MG/20ML

▾

INJECTABLE;INJECTION | Approved: 2023-09-29 00:00:00