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RIABNI

Biosimilar

RITUXIMAB-ARRX | B761140 | AMGEN INC

1 product0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

December 17, 2032(2359 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 17, 2032	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Apr. 3, 20456849 days remaining

Based on latest discovered patent 12269867(manufacturing) · relevance 72/100

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

Approved Biosimilars

RiabniBLA 761140RiabniBLA 761140

Discovered Patents

View all 280 patents →

Top 50 of 280 AI-discovered patents by relevance.

Composition

(22)

85/10011427627Grant: 2022-08-30 | Exp: 2042-08-25

75/10010683368Grant: 2020-06-16 | Exp: 2040-06-11

75/10011242396Grant: 2022-02-08 | Exp: 2042-02-03

75/1007297775Grant: 2007-11-20 | Exp: 2027-11-15

75/10010919953Grant: 2021-02-16 | Exp: 2041-02-11

75/1008143380Grant: 2012-03-27 | Exp: 2032-03-22

72/1009822173Grant: 2017-11-21 | Exp: 2037-11-16

72/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

72/10011142563Grant: 2021-10-12 | Exp: 2041-10-07

72/10010040843Grant: 2018-08-07 | Exp: 2038-08-02

70/1008734796Grant: 2014-05-27 | Exp: 2034-05-22

70/1009803191Grant: 2017-10-31 | Exp: 2037-10-26

70/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

70/10011440971Grant: 2022-09-13 | Exp: 2042-09-08

70/1006242195Grant: 2001-06-05 | Exp: 2021-05-31

70/1007741072Grant: 2010-06-22 | Exp: 2030-06-17

70/10010577431Grant: 2020-03-03 | Exp: 2040-02-27

70/1006660843Grant: 2003-12-09 | Exp: 2023-12-04

70/1007364731Grant: 2008-04-29 | Exp: 2028-04-24

70/10011993663Grant: 2024-05-28 | Exp: 2044-05-23

70/1007943135Grant: 2011-05-17 | Exp: 2031-05-12

70/10010899845Grant: 2021-01-26 | Exp: 2041-01-21

Formulation

(6)

70/1006994840Grant: 2006-02-07 | Exp: 2026-02-02

70/10011040102Grant: 2021-06-22 | Exp: 2041-06-17

70/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

70/10011103584Grant: 2021-08-31 | Exp: 2041-08-26

70/1009574005Grant: 2017-02-21 | Exp: 2037-02-16

70/10010188735Grant: 2019-01-29 | Exp: 2039-01-24

Method of Use

(3)

80/1009726673Grant: 2017-08-08 | Exp: 2037-08-03

75/1008828666Grant: 2014-09-09 | Exp: 2034-09-04

75/1009733245Grant: 2017-08-15 | Exp: 2037-08-10

Manufacturing

(18)

80/10011802165Grant: 2023-10-31 | Exp: 2043-10-26

75/10011299539Grant: 2022-04-12 | Exp: 2042-04-07

75/10011312745Grant: 2022-04-26 | Exp: 2042-04-21

75/1009365881Grant: 2016-06-14 | Exp: 2036-06-09

75/1008809051Grant: 2014-08-19 | Exp: 2034-08-14

75/1009884904Grant: 2018-02-06 | Exp: 2038-02-01

75/10010590164Grant: 2020-03-17 | Exp: 2040-03-12

72/1007794970Grant: 2010-09-14 | Exp: 2030-09-09

72/1008524470Grant: 2013-09-03 | Exp: 2033-08-29

72/1009562252Grant: 2017-02-07 | Exp: 2037-02-02

72/10012269867Grant: 2025-04-08 | Exp: 2045-04-03

70/10011649262Grant: 2023-05-16 | Exp: 2043-05-11

70/1009481902Grant: 2016-11-01 | Exp: 2036-10-27

70/1009657054Grant: 2017-05-23 | Exp: 2037-05-18

70/1009096879Grant: 2015-08-04 | Exp: 2035-07-30

70/1009422329Grant: 2016-08-23 | Exp: 2036-08-18

70/1008217153Grant: 2012-07-10 | Exp: 2032-07-05

70/1008710196Grant: 2014-04-29 | Exp: 2034-04-24

Diagnostic

(1)

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

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 761140 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

rituximab-arrx

Applicant

Amgen Inc.

Approval Date

17-Dec-20

Reference Product: Rituxan — rituximab

Presentations

100MG/10ML (10MG/ML) — Single-Dose Vial (Intravenous)

500MG/50ML (10MG/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 10, 2025	SUPPL -4	View Letter (PDF)
Jun 6, 2022	SUPPL -1	View Letter (PDF)
Dec 21, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/10ML(10MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2020-12-17 00:00:00

No patent or exclusivity listings for this strength.