Viewing data from:

OPDIVO

BLA

NIVOLUMAB | B125527 | 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Bristol-Myers Squibb Co. et al v. Merck & Co., Inc. et al 1:2015cv00572 2 patentsnivolumab	D. Del.	2015-07-07	Terminated 2017-01-23	—
Bristol-Myers Squibb Co. et al v. Merck & Co., Inc. et al 1:2015cv00560 2 patentsnivolumab; pembrolizumab	D. Del.	2015-06-30	Terminated 2017-01-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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
Mar 5, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG/4ML

▴

INJECTABLE;INJECTION | Approved: 2015-03-04 00:00:00

No patent or exclusivity listings for this strength.

#002 — 100MG/10ML

▾

INJECTABLE;INJECTION | Approved: 2015-03-04 00:00:00