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TRUXIMA

Interchangeable Biosimilar

RITUXIMAB-ABBS | B761088 | CELLTRION INC

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

November 28, 2030(1485 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.

Approved Biosimilars

TruximaBLA 761088ICTruximaBLA 761088IC

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

Medicare Part B Spending

CMS physician-administered drug spending for Truxima (2024)

Total Spending

$126.8M

Total Claims

46,174

Beneficiaries

15,052

ASP Price

$33.54

Spending Trend

$358K(2019)→$185.7M(2020)→$233.6M(2021)→$195.5M(2022)→$174.6M(2023)→$126.8M(2024)

YoY Change:-23.3%

5yr CAGR:-18.4%

HCPCS: Q5115 — Injection, rituximab-abbs, biosimilar, (truxima), 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Purple Book (Biologics)

BLA 761088 | 2 presentations

InterchangeableLicensedCDERInjection

Proper Name

rituximab-abbs

Applicant

CELLTRION, Inc.

Approval Date

November 28, 2018

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

9 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2026	SUPPL -35	View Letter (PDF)
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)

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

No patent or exclusivity listings for this strength.

#002 — 500MG/50ML(10MG/ML)

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