Praluent® (alirocumab)

BL 125559

Praluent® (alirocumab)

BL 125559

U.S. License Holder:

Sanofi Aventis

Date of License:

July-24-2015

Last Update:

February-15-2019

approved_indications FDA-Approved Indications

PRALUENT (alirocumab) is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol (LDL-C).

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:14-cv-01317 (D. Del.)

U.S. Patent Nos.
8,563,698 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)) 8,829,165 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)) 8,859,741 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)) 8,871,913 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)) 8,871,914 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)) 8,883,983 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)) 8,889,834 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9))

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.; Amgen USA, Inc.

Defendants
Regeneron Pharmaceuticals, Inc.; Sanofi; Sanofi-Aventis US LLC; Aventisub LLC

Federal Circuit Appeal(s)
17-1480

Supreme Court Appeal(s)
18-127

Status
District Court Determination that Patents Valid and Infringed; Federal Circuit Decision Reversing-In-Part, Affirming-In-Part, Vacating-In-Part, and Remanding for New Trial on Written Description and Enablement; Remand Pending; Petition for Rehearing En Banc Denied; Supreme Court Writ of Certiorari Denied

BPCIA
N

1:14-cv-01349 (D. Del.)

U.S. Patent Nos.
8,871,913 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)) 8,871,914 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9))

Plaintiffs
Amgen Inc.

Defendants
Regeneron Pharmaceuticals, Inc.; Sanofi; Sanofi-Aventis US LLC; Aventisub LLC

Federal Circuit Appeal(s)
17-1480

Supreme Court Appeal(s)
18-127

Status
Consolidated with 1:14-cv-01317 (D. Del.); Federal Circuit Decision Reversing-In-Part, Affirming-In-Part, Vacating-In-Part, and Remanding in Lead Case; Remand Pending (1:14-cv-01317; Fed. Cir. 2017-1480); Supreme Court Writ of Certiorari Denied

BPCIA
N

1:14-cv-01393 (D. Del.)

U.S. Patent Nos.
8,883,983 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9))

Plaintiffs
Amgen Inc.

Defendants
Regeneron Pharmaceuticals, Inc.; Sanofi; Sanofi-Aventis US LLC; Aventisub LLC

Federal Circuit Appeal(s)
17-1480

Supreme Court Appeal(s)
18-127

Status
Consolidated with 1:14-cv-01317 (D. Del.); Federal Circuit Decision Reversing-In-Part, Affirming-In-Part, Vacating-In-Part, and Remanding in Lead Case; Remand Pending (1:14-cv-01317; Fed. Cir. 2017-1480); Supreme Court Writ of Certiorari Denied

BPCIA
N

1:14-cv-01414 (D. Del.)

U.S. Patent Nos.
8,889,834 (Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9))

Plaintiffs
Amgen Inc.

Defendants
Regeneron Pharmaceuticals, Inc.; Sanofi; Sanofi-Aventis US LLC; Aventisub LLC

Federal Circuit Appeal(s)
17-1480

Supreme Court Appeal(s)
18-127

Status
Consolidated with 1:14-cv-01317 (D. Del.); Federal Circuit Decision Reversing-In-Part, Affirming-In-Part, Vacating-In-Part, and Remanding in Lead Case; Remand Pending (1:14-cv-01317; Fed. Cir. 2017-1480); Supreme Court Writ of Certiorari Denied

BPCIA
N

2:15-cv-05685 (C.D. Cal.)

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Regeneron Pharmaceuticals, Inc.; Sanofi-Aventis US LLC

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

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Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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