Viewing data from:

DANYELZA

BLA

NAXITAMAB-GQGK | B761171 | Y-MABS THERAPEUTICS INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 25, 2032(2337 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 25, 2032	Active	Computed
7-Year Orphan	Nov. 25, 2027	Active	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 7, 20405057 days remaining

Based on latest discovered patent 10647997(composition) · relevance 88/100

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

Discovered Patents

View all 1 patents →

1 AI-discovered patents, sorted by relevance.

Composition

(1)

88/10010647997Grant: 2020-05-12 | Exp: 2040-05-07

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 761171

351(a) ReferenceLicensedCDERInjection

Proper Name

naxitamab-gqgk

Applicant

Y-mABs Therapeutics, Inc

Approval Date

25-Nov-20

Orphan Exclusivity

25-Nov-27

1y 4mo remaining

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 29, 2025	SUPPL -13	View Letter (PDF)
Mar 21, 2024	SUPPL -8	View Letter (PDF)
Nov 27, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/10ML

▴

SOLUTION;INTRAVENOUS | Approved: 2020-11-25 00:00:00

No patent or exclusivity listings for this strength.