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BAVENCIO

BLA

AVELUMAB | B761078 | EMD SERONO INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bristol-Myers Squibb Co. et al v. EMD Serono, Inc. et al 1:2017cv01029 6 patentsavelumab	D. Del.	2017-07-26	Terminated 2019-02-12	—

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
May 9, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/ML

▴

INJECTABLE;INTRAVENOUS | Approved: 2017-05-09 00:00:00

No patent or exclusivity listings for this strength.