Fulphila® — Venable's BiologicsHQ

U.S. License Holder:

Mylan / Biocon

Date of License:

June-04-2018

Last Update:

Nov-15-2024

FDA-Approved Indications

FULPHILA (pegfilgrastim-jmdb) is a leukocyte growth factor indicated to:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Fulphila® (Mylan / Biocon) (May-2019)

Biosimilars Approved In The E.U.

Fulphila® (Mylan / Biocon) (November-2018)

Biosimilars Approved In Australia

Fulphila® (Alphapharm / Mylan / Biocon) (August-2018)

U.S. Patent Litigations

PACER

Case No(s):

2:17-cv-01235 (W.D. Pa.)

U.S. Patent Nos.
8,273,707 (Process for Purifying Proteins) 9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Mylan Inc.; Mylan GmbH; Mylan NV; Mylan Pharmaceuticals, Inc.

Status
Terminated: Judgment of Non-Infringement of '707 Patent Entered; Stipulated to Non-Infringement of '997 Patent

BPCIA
Y

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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Fulphila® (pegfilgrastim-jmdb)

Fulphila® (pegfilgrastim-jmdb)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

U.S. Patent Litigations

Case No(s):

2:17-cv-01235 (W.D. Pa.)

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