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FILKRI

Biosimilar

FILGRASTIM-LAHA | B761027 | ACCORD BIOPHARMA INC.

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

January 15, 2038(4090 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 15, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

FilkriBLA 761027FilkriBLA 761027

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Amgen Inc. et al v. Accord BioPharma 0:2018cv61828 4 patentsfilgrastim, pegfilgrastim	S.D. Fla.	2018-08-07	Terminated 2019-11-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 761027 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

filgrastim-laha

Applicant

Accord BioPharma Inc.

Approval Date

January 15, 2026

Reference Product: Neupogen — filgrastim

Presentations

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

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

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 20, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 300MCG/0.5ML

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INJECTABLE;INJECTION | Approved: 2026-01-15 00:00:00

No patent or exclusivity listings for this strength.

#002 — 480MCG/0.8ML

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INJECTABLE;INJECTION | Approved: 2026-01-15 00:00:00