Viewing data from:

NEMLUVIO

BLA

NEMOLIZUMAB-ILTO | B761390 | GALDERMA LABS LP

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 12, 2036(3693 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 12, 2036	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jun. 30, 20425841 days remaining

Based on latest discovered patent 11376261(diagnostic) · relevance 75/100

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

Discovered Patents

View all 2 patents →

2 AI-discovered patents, sorted by relevance.

Manufacturing

(1)

60/1009504236Grant: 2016-11-29 | Exp: 2036-11-24

Diagnostic

(1)

75/10011376261Grant: 2022-07-05 | Exp: 2042-06-30

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 761390

351(a) ReferenceLicensedCDERFor Injection

Proper Name

nemolizumab-ilto

Applicant

Galderma Laboratories, L.P.

Approval Date

12-Aug-24

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 27, 2025	SUPPL -2	View Letter (PDF)
Apr 25, 2025	SUPPL -1	View Letter (PDF)
Aug 13, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG

▴

INJECTABLE;INJECTION | Approved: 2024-08-12 00:00:00

No patent or exclusivity listings for this strength.