Viewing data from:

OPDIVO QVANTIG

BLA

NIVOLUMAB;HYALURONIDASE-NVHY | B761429 | BRISTOL-MYERS SQUIBB

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
Dec 30, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG;10000 UNITS PER 5ML(120MG/2000UNITS PER ML)

▴

INJECTABLE;INJECTION | Approved: 2024-12-27 00:00:00

No patent or exclusivity listings for this strength.