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BLA

AMIVANTAMAB AND HYALURONIDASE-LPUJ | B761484 | JANSSEN BIOTECH

4 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

February 13, 2038(4119 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Feb. 13, 2038	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 761484 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

amivantamab and hyaluronidase-lpuj

Applicant

Janssen Biotech, Inc.

Approval Date

February 13, 2026

Presentations

1,600MG/10ML; 20,000UNITS/10ML (160MG/2,000UNITS/ML) — Single-Dose Vial (Subcutaneous)

2,240MG/14ML; 28,000UNITS/14ML (160MG/2,000UNITS/ML) — Single-Dose Vial (Subcutaneous)

2,400MG/15ML; 30,000UNITS (160MG/2,000UNITS/ML) — Single-Dose Vial (Subcutaneous)

3,520MG/22ML; 44,000UNITS (160MG/2,000UNITS/ML) — Single-Dose Vial (Subcutaneous)

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 20, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1,600MG/20,000 UNITS PER 10ML

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VIAL; SINGLE-USE | Approved: 2026-02-13 00:00:00

No patent or exclusivity listings for this strength.

#002 — 2,240MG/28,000 UNITS PER 14ML

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VIAL; SINGLE-USE | Approved: 2026-02-13 00:00:00

#003 — 2,400MG/30,000 UNITS PER 15ML

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VIAL; SINGLE-USE | Approved: 2026-02-13 00:00:00

#004 — 3,5200MG/44,000 UNITS PER 22ML

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VIAL; SINGLE-USE | Approved: 2026-02-13 00:00:00