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LYUMJEV

BLA

INSULIN LISPRO-AABC | B761109 | ELI LILLY AND CO

2 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 15, 2032(2174 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 15, 2032	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jan. 11, 20446401 days remaining

Based on latest discovered patent 11872266(composition) · relevance 87/100

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

Discovered Patents

View all 13 patents →

13 AI-discovered patents, sorted by relevance.

Composition

(3)

92/1006444641Grant: 2002-09-03 | Exp: 2022-08-29

87/10011872266Grant: 2024-01-16 | Exp: 2044-01-11

72/10010035839Grant: 2018-07-31 | Exp: 2038-07-26

Formulation

(9)

92/1009439952Grant: 2016-09-13 | Exp: 2036-09-08

92/10011123406Grant: 2021-09-21 | Exp: 2041-09-16

88/1009901623Grant: 2018-02-27 | Exp: 2038-02-22

86/10010925931Grant: 2021-02-23 | Exp: 2041-02-18

85/10010172922Grant: 2019-01-08 | Exp: 2039-01-03

82/10011207384Grant: 2021-12-28 | Exp: 2041-12-23

80/10011510967Grant: 2022-11-29 | Exp: 2042-11-24

78/1009993555Grant: 2018-06-12 | Exp: 2038-06-07

70/1009339529Grant: 2016-05-17 | Exp: 2036-05-12

Device

(1)

72/10011045601Grant: 2021-06-29 | Exp: 2041-06-24

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 761109 | 6 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin lispro-aabc

Applicant

Eli Lilly and Company

Approval Date

15-Jun-20

Presentations

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

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

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

600UNITS/3ML (200UNITS/ML) — Autoinjector (Intravenous, Subcutaneous)

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 17, 2022	SUPPL -4	View Letter (PDF)
Aug 16, 2021	SUPPL -3	View Letter (PDF)
Jan 26, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100UNITS/ML(U-100)

▴

INJECTABLE;INJECTION | Approved: 2020-06-15 00:00:00

No patent or exclusivity listings for this strength.

#002 — 200UNITS/ML(U-200)

▾

INJECTABLE;INJECTION | Approved: 2020-06-15 00:00:00