Viewing data from:

GARZULYS

Interchangeable Biosimilar

INSULIN ASPART-FSAN | B761497 | EMERGE BIOSCIENCE PTE. LTD.

2 products0 Purple Book patents4 biosimilars

Biologic LOEBiosimilar competition

4 approved biosimilars

July 24, 2038(4280 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 24, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

GarzulysBLA 761497ICGarzulysBLA 761497ICGarzulysBLA 761497ICGarzulysBLA 761497IC

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 761497 | 4 presentations

InterchangeableLicensedCDERInjection

Proper Name

insulin aspart-fsan

Applicant

Emerge Bioscience Pte. Ltd.

Approval Date

July 24, 2026

Reference Product: Novolog — insulin aspart

Presentations

1,000UNITS/10ML (100UNITS/ML) — Multi-Dose Vial (Intravenous, Subcutaneous)

300UNITS/3ML (100UNITS/ML) — Autoinjector (Subcutaneous)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 16, 2026	ORIG -2	View Letter (PDF)
Jul 28, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 3ML

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PEN;PREFILLED | Approved: 2026-07-24 00:00:00

No patent or exclusivity listings for this strength.

#002 — 10ML

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VIAL; MULTIDOSE | Approved: 2026-07-24 00:00:00