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Biosimilar

PEGFILGRASTIM-FPGK | B761173 | FRESENIUS KABI USA

1 product0 Purple Book patents1 biosimilar

Biologic LOEBiosimilar competition

1 approved biosimilar

September 1, 2034(2982 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 1, 2034	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

StimufendBLA 761173

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 761173

BiosimilarLicensedCDERInjection

Proper Name

pegfilgrastim-fpgk

Applicant

Fresenius Kabi USA, LLC

Approval Date

1-Sep-22

Reference Product: Neulasta — pegfilgrastim

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 6MG/0.6ML

▴

SOLUTION; INJECTION | Approved: 2022-09-01 00:00:00

No patent or exclusivity listings for this strength.