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LEROCHOL

BLA

LERODALCIBEP-LIGA | B761427 | LIB THERAPEUTICS, INC.

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 12, 2037(4180 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 12, 2037	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 761427

351(a) ReferenceLicensedCDERInjection

Proper Name

lerodalcibep-liga

Applicant

LIB Therapeutics, Inc.

Approval Date

12-Dec-25

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 15, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/1.2ML

▴

INJECTABLE;INJECTION | Approved: 2025-12-12 00:00:00

No patent or exclusivity listings for this strength.