Viewing data from:

RYBREVANT FASPRO

BLA

AMIVANTAMAB AND HYALURONIDASE-LPUJ | B761484 | JANSSEN BIOTECH

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

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

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

▴

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

▾

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

#003 — 2,400MG/30,000 UNITS PER 15ML

▾

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

#004 — 3,5200MG/44,000 UNITS PER 22ML

▾

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