Viewing data from:

TRUXIMA

Biosimilar

RITUXIMAB-ABBS | B761088 | CELLTRION INC

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

November 28, 2030(1609 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 28, 2030	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 18, 20457017 days remaining

Based on latest discovered patent 12421324(formulation) · relevance 70/100

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

Approved Biosimilars

TruximaBLA 761088TruximaBLA 761088

Discovered Patents

View all 208 patents →

Top 50 of 208 AI-discovered patents by relevance.

Composition

(17)

94/1009321843Grant: 2016-04-26 | Exp: 2036-04-21

89/1008999324Grant: 2015-04-07 | Exp: 2035-04-02

75/1006503510Grant: 2003-01-07 | Exp: 2023-01-02

75/1007863419Grant: 2011-01-04 | Exp: 2030-12-30

75/1006194551Grant: 2001-02-27 | Exp: 2021-02-22

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

72/1008722859Grant: 2014-05-13 | Exp: 2034-05-08

72/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

72/1006271362Grant: 2001-08-07 | Exp: 2021-08-02

70/1009545086Grant: 2017-01-17 | Exp: 2037-01-12

70/1006869605Grant: 2005-03-22 | Exp: 2025-03-17

70/1006538124Grant: 2003-03-25 | Exp: 2023-03-20

70/10011718678Grant: 2023-08-08 | Exp: 2043-08-03

65/10011236168Grant: 2022-02-01 | Exp: 2042-01-27

65/1006528624Grant: 2003-03-04 | Exp: 2023-02-27

65/1007364731Grant: 2008-04-29 | Exp: 2028-04-24

65/1008242247Grant: 2012-08-14 | Exp: 2032-08-09

Formulation

(8)

78/1008318161Grant: 2012-11-27 | Exp: 2032-11-22

75/1008758747Grant: 2014-06-24 | Exp: 2034-06-19

70/10012421324Grant: 2025-09-23 | Exp: 2045-09-18

70/1009254321Grant: 2016-02-09 | Exp: 2036-02-04

65/10011596620Grant: 2023-03-07 | Exp: 2043-03-02

65/10011103584Grant: 2021-08-31 | Exp: 2041-08-26

65/1009662395Grant: 2017-05-30 | Exp: 2037-05-25

65/10010188735Grant: 2019-01-29 | Exp: 2039-01-24

Method of Use

(1)

70/1008828666Grant: 2014-09-09 | Exp: 2034-09-04

Manufacturing

(23)

78/10011078294Grant: 2021-08-03 | Exp: 2041-07-29

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

75/10011802165Grant: 2023-10-31 | Exp: 2043-10-26

75/10011987638Grant: 2024-05-21 | Exp: 2044-05-16

75/10011639395Grant: 2023-05-02 | Exp: 2043-04-27

75/10010501491Grant: 2019-12-10 | Exp: 2039-12-05

72/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

72/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

72/10011976127Grant: 2024-05-07 | Exp: 2044-05-02

72/10011905325Grant: 2024-02-20 | Exp: 2044-02-15

72/10010975168Grant: 2021-04-13 | Exp: 2041-04-08

70/1009631008Grant: 2017-04-25 | Exp: 2037-04-20

70/10010590454Grant: 2020-03-17 | Exp: 2040-03-12

70/1008574869Grant: 2013-11-05 | Exp: 2033-10-31

68/10010329595Grant: 2019-06-25 | Exp: 2039-06-20

68/1009752159Grant: 2017-09-05 | Exp: 2037-08-31

68/10012173080Grant: 2024-12-24 | Exp: 2044-12-19

68/10012286619Grant: 2025-04-29 | Exp: 2045-04-24

68/10011028149Grant: 2021-06-08 | Exp: 2041-06-03

65/1009068212Grant: 2015-06-30 | Exp: 2035-06-25

65/1009631007Grant: 2017-04-25 | Exp: 2037-04-20

65/1007575893Grant: 2009-08-18 | Exp: 2029-08-13

65/10010590186Grant: 2020-03-17 | Exp: 2040-03-12

Diagnostic

(1)

75/1008227195Grant: 2012-07-24 | Exp: 2032-07-19

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 761088 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

rituximab-abbs

Applicant

CELLTRION, Inc.

Approval Date

28-Nov-18

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

8 letters from Drugs@FDA

Date	Submission	Document
Jun 10, 2025	SUPPL -32	View Letter (PDF)
Feb 8, 2022	SUPPL -18	View Letter (PDF)
Jun 2, 2020	SUPPL -9	View Letter (PDF)
Dec 23, 2019	SUPPL -5	View Letter (PDF)
Dec 23, 2019	SUPPL -6	View Letter (PDF)
May 31, 2019	SUPPL -2	View Letter (PDF)
May 31, 2019	SUPPL -1	View Letter (PDF)
Feb 26, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/10ML(10MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2018-11-28 00:00:00

No patent or exclusivity listings for this strength.

#002 — 500MG/50ML(10MG/ML)

▾

INJECTABLE;INJECTION | Approved: 2018-11-28 00:00:00