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FILKRI

BLA

FILGRASTIM-LAHA | B761027 | ACCORD BIOPHARMA INC.

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

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

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