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HUMULIN 70/30

BLA

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | B019717 | LILLY

2 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

November 7, 2025(238 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 7, 2025	Expired	Computed

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

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 19717 | 3 presentations

351(a) ReferenceLicensedCDERInjectable Suspension

Proper Name

insulin isophane human and insulin human

Applicant

Eli Lilly and Company

Approval Date

25-Apr-89

700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML) — Multi-Dose Vial (Subcutaneous)

210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) — Multi-Dose Vial (Subcutaneous)

210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) — Autoinjector (Subcutaneous)

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

Approval Letters

26 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 30 UNITS/ML;70 UNITS/ML

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INJECTABLE;INJECTION | Approved: 1989-04-25 00:00:00

No patent or exclusivity listings for this strength.

#002 — 30 UNITS/ML;70 UNITS/ML

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INJECTABLE;INJECTION | Approved: 1989-04-25 00:00:00