Grastofil (filgrastim)

Grastofil Approval Pending

Grastofil (filgrastim)

Grastofil Approval Pending

U.S. License Holder:

Apotex

Date of License:

aBLA accepted by FDA February-2015

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

GRASTOFIL (filgrastim) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Grastofil (Apotex) (December-2015)

Biosimilars Approved In The E.U.

Grastofil (Apotex) (October-2013)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01542

U.S. Patent No.
8,952,138 (Refolding Proteins Using a Chemically Controlled Redox State)

Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.

Petitioner(s)
Apotex Inc.; Apotex Corp.

§ 102 Challenge
Y: Claims 1-7, 10, 12-17, 19, 22-23

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-24

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-2171

Supreme Court Appeal(s)
20-74

IPR Status
Final Written Decision (Most Challenged Claims Unpatentable, 1 Claim Not Unpatentable); Request for Rehearing Determined All Claims Unpatentable; Petition for Writ of Certiorari Granted, Vacating and Remanding to the Federal Circuit for Consideration in Light of Arthrex; Federal Circuit Vacated and Remanded Due to Arthrex; Joint Motion to Terminate Remand Pending; Request for Director Review Denied; Federal Circuit Reversed (No Claims Found Unpatentable)

PGR2019-00001

U.S. Patent No.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)

Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.

Petitioner(s)
Adello Biologics, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC; ApoPharma USA, Inc.; Apotex Corp.; Apotex Holdings, Inc.; Apotex Inc.; Apotex Pharmaceutical Holdings Inc.; Intas Pharmaceuticals Ltd.; Kashiv BioSciences, LLC

§ 102 Challenge
Y: Claims 1-4, 7-19, 22-3

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Challenges Also Include Indefiniteness (Claims 1-15), Written Description (Claims 1-9, 16-25), and Enablement (Claims 1-30). Settled After Institution Decision

approved_indications U.S. Patent Litigations

PACER

Case No(s):

0:15-cv-62081 (S.D. Fla.)

U.S. Patent Nos.
6,162,427 (Combination of G-CSF with a Chemotherapeutic Agent for Stem Cell Mobilization) 8,952,138 (Refolding Proteins using a Chemically Controlled Redox State)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Apotex, Inc.; Apotex Corp.

Federal Circuit Appeal(s)
17-1010

Status
Consolidated with 0:15-cv-61631 (S.D. Fla.); District Court: '427 Patent Settled, '138 Patent Not Infringed, Not Unenforceable, Invalidity Dismissed; Affirmed on Appeal (17-1010)

BPCIA
Y

0:18-cv-61828 (S.D. Fla.)

U.S. Patent Nos.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Apotex Corp.; Apotex Inc.; Accord BioPharma

Status
Stipulated Dismissal

BPCIA
Y

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September 6, 2018

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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