Viewing data from:

UDENYCA

Biosimilar

PEGFILGRASTIM-CBQV | B761039 | COHERUS BIOSCIENCES INC

1 product0 Purple Book patents3 biosimilars

Biologic LOEBiosimilar competition

3 approved biosimilars

November 2, 2030(1583 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 2, 2030	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jan. 20, 20425680 days remaining

Based on latest discovered patent 11229683(method of use) · relevance 88/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Approved Biosimilars

UdenycaBLA 761039UdenycaBLA 761039Udenyca OnbodyBLA 761039

Discovered Patents

View all 1 patents →

1 AI-discovered patents, sorted by relevance.

Method of Use

(1)

88/10011229683Grant: 2022-01-25 | Exp: 2042-01-20

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 761039 | 3 presentations

BiosimilarLicensedCDERInjection

Proper Name

pegfilgrastim-cbqv

Applicant

Accord BioPharma Inc.

Approval Date

2-Nov-18

Reference Product: Neulasta — pegfilgrastim

Presentations

6MG/0.6ML — Pre-Filled Syringe (Subcutaneous)

6MG/0.6ML — Autoinjector (Subcutaneous)

6MG/0.6ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2023	SUPPL -15	View Letter (PDF)
Mar 6, 2023	SUPPL -13	View Letter (PDF)
Nov 29, 2022	SUPPL -14	View Letter (PDF)
Jun 8, 2021	SUPPL -10	View Letter (PDF)
Feb 13, 2020	SUPPL -3	View Letter (PDF)
Oct 21, 2019	ORIG -1	View Letter (PDF)
Oct 21, 2019	SUPPL -4	View Letter (PDF)
Apr 18, 2019	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 6MG/0.6ML

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INJECTABLE;INJECTION | Approved: 2018-11-02 00:00:00

No patent or exclusivity listings for this strength.