Viewing data from:

ENNUMO

Biosimilar

PEGFILGRASTIM-PCCG | B761147 | ACCORD BIOPHARMA INC.

1 product0 Purple Book patents1 biosimilar

Biologic LOEBiosimilar competition

1 approved biosimilar

May 7, 2038(4202 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 7, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

EnnumoBLA 761147

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 761147

BiosimilarLicensedCDERInjection

Proper Name

pegfilgrastim-pccg

Applicant

Accord BioPharma Inc.

Approval Date

May 7, 2026

Reference Product: Neulasta — pegfilgrastim

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 12, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 6MG/0.6ML

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INJECTABLE;SUBCUTANEOUS | Approved: 2026-05-07 00:00:00

No patent or exclusivity listings for this strength.