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HUMALOG (INSULIN LISPRO RECOMBINANT) | LOERadar

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HUMALOG

BLA

INSULIN LISPRO RECOMBINANT | B020563 | LILLY

5 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 6, 2029(1069 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 6, 2029	Active	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 20563 | 6 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin lispro

Applicant

Eli Lilly and Company

Approval Date

14-Jun-96

Presentations

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

300UNITS/3ML (100UNITS/ML) — Multi-Dose Cartridge (Subcutaneous)

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

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

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

300UNITS/3ML (100UNITS/ML) — Multi-Dose Vial (Intravenous, Subcutaneous)

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

Approval Letters

38 letters from Drugs@FDA

Date	Submission	Document
May 14, 2025	SUPPL -214	View Letter (PDF)
Jul 24, 2023	SUPPL -202	View Letter (PDF)
Mar 23, 2020	SUPPL -13	View Letter (PDF)
Mar 23, 2020	SUPPL -24	View Letter (PDF)
Mar 23, 2020	SUPPL -27	View Letter (PDF)
Mar 23, 2020	SUPPL -32	View Letter (PDF)
Mar 23, 2020	SUPPL -36	View Letter (PDF)
Mar 23, 2020	SUPPL -40	View Letter (PDF)
Mar 23, 2020	SUPPL -46	View Letter (PDF)
Mar 23, 2020	SUPPL -65	View Letter (PDF)
Mar 23, 2020	SUPPL -75	View Letter (PDF)
Mar 23, 2020	SUPPL -76	View Letter (PDF)
Mar 23, 2020	SUPPL -98	View Letter (PDF)
Mar 23, 2020	SUPPL -105	View Letter (PDF)
Mar 23, 2020	SUPPL -127	View Letter (PDF)
Mar 23, 2020	SUPPL -157	View Letter (PDF)
Mar 23, 2020	SUPPL -12	View Letter (PDF)
Mar 23, 2020	SUPPL -41	View Letter (PDF)
Mar 23, 2020	SUPPL -123	View Letter (PDF)
Mar 23, 2020	SUPPL -10	View Letter (PDF)
Mar 23, 2020	SUPPL -163	View Letter (PDF)
Mar 23, 2020	SUPPL -16	View Letter (PDF)
Mar 23, 2020	SUPPL -44	View Letter (PDF)
Mar 23, 2020	SUPPL -54	View Letter (PDF)
Mar 23, 2020	SUPPL -64	View Letter (PDF)
Mar 23, 2020	SUPPL -82	View Letter (PDF)
Mar 23, 2020	SUPPL -91	View Letter (PDF)
Mar 23, 2020	SUPPL -115	View Letter (PDF)
Mar 23, 2020	SUPPL -172	View Letter (PDF)
Mar 23, 2020	SUPPL -176	View Letter (PDF)
Mar 23, 2020	SUPPL -191	View Letter (PDF)
Mar 23, 2020	SUPPL -190	View Letter (PDF)
Mar 23, 2020	SUPPL -195	View Letter (PDF)
Mar 23, 2020	SUPPL -199	View Letter (PDF)
Mar 23, 2020	SUPPL -196	View Letter (PDF)
Mar 23, 2020	SUPPL -198	View Letter (PDF)
Mar 23, 2020	SUPPL -124	View Letter (PDF)
Mar 23, 2020	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 100 UNITS/ML

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INJECTABLE;INJECTION | Approved: 1996-06-14 00:00:00

No patent or exclusivity listings for this strength.

#003 — 100 UNITS/ML

▾

INJECTABLE;INJECTION | Approved: 1996-06-14 00:00:00

#004 — 200UNITS/ML

▾

INJECTABLE;INJECTION | Approved: 1996-06-14 00:00:00

#002 — 100 UNITS/ML

▾

INJECTABLE;INJECTION | Approved: 1996-06-14 00:00:00

#005 — 100UNITS/ML

▾

INJECTABLE;INJECTION | Approved: 1996-06-14 00:00:00