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ZARXIO

Biosimilar

FILGRASTIM-SNDZ | B125553 | SANDOZ INC

2 products0 Purple Book patents4 biosimilars

Biologic LOEBiosimilar competition

4 approved biosimilars

March 6, 2027(122 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 6, 2027	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

ZarxioBLA 125553ZarxioBLA 125553ZarxioBLA 125553ZarxioBLA 125553

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 Zarxio (2024)

Total Spending

$9.4M

Total Claims

57,172

Beneficiaries

12,437

ASP Price

$0.34

Spending Trend

$37.2M(2019)→$28.7M(2020)→$18.7M(2021)→$13.8M(2022)→$3.2M(2023)→$9.4M(2024)

YoY Change:+62.2%

5yr CAGR:-8.3%

HCPCS: Q5101 — Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram

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

Purple Book (Biologics)

BLA 125553 | 4 presentations

BiosimilarLicensedCDERInjection

Proper Name

filgrastim-sndz

Applicant

Sandoz Inc.

Approval Date

March 6, 2015

Reference Product: Neupogen — filgrastim

Presentations

300MCG/0.5ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

480MCG/0.8ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

300MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

480MCG/1.6ML (300MCG/ML) — Single-Dose Vial (Intravenous, Subcutaneous)

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Apr 20, 2026	SUPPL -39	View Letter (PDF)
Aug 22, 2025	SUPPL -44	View Letter (PDF)
Oct 23, 2024	SUPPL -38	View Letter (PDF)
Aug 12, 2024	SUPPL -35	View Letter (PDF)
Jan 23, 2024	SUPPL -36	View Letter (PDF)
Jul 27, 2021	SUPPL -23	View Letter (PDF)
Aug 2, 2019	SUPPL -17	View Letter (PDF)
Feb 23, 2017	SUPPL -7	View Letter (PDF)
Mar 4, 2016	SUPPL -1	View Letter (PDF)
Mar 6, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 300 mcg/0.5 mL

▴

INJECTABLE;INJECTION | Approved: 2015-03-06 00:00:00

No patent or exclusivity listings for this strength.

#002 — 480 mcg/0.8 mL

▾

INJECTABLE;INJECTION | Approved: 2015-03-06 00:00:00