Praluent® (alirocumab)

BL 125559

Praluent® (alirocumab)

BL 125559

U.S. License Holder:

Sanofi Aventis

Date of License:

July-24-2015

Last Update:

October-23-2021

approved_indications FDA-Approved Indications

PRALUENT (alirocumab) is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor indicated:

To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease;

As adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C;

As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce 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; 20-1074

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; Petition for Rehearing En Banc Denied; Supreme Court Writ of Certiorari Denied; On Remand Jury Found Three Claims Not Invalid and Two Claims Invalid for Lack of Written Description, Defendant's Motion for JMOL Denied as to Written Description but Granted as to Enablement, Motion for New Trial Denied, Motion for Permanent Injunction Denied as Moot because Claims Not Enabled; Federal Circuit Appeal Affirmed, Request for Panel and En Banc Rehearing 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; 20-1074

Supreme Court Appeal(s)
18-127

Status
Consolidated with 1:14-cv-01317 (D. Del.); 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 in Lead Case (1:14-cv-01317; Fed. Cir. 2017-1480); Petition for Rehearing En Banc Denied; Supreme Court Writ of Certiorari Denied; On Remand Jury Found Three Claims Not Invalid and Two Claims Invalid for Lack of Written Description, Defendant's Motion for JMOL Denied as to Written Description but Granted as to Enablement, Motion for New Trial Denied, Motion for Permanent Injunction Denied as Moot because Claims Not Enabled; Federal Circuit Appeal Affirmed, Request for Panel and En Banc Rehearing 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; 20-1074

Supreme Court Appeal(s)
18-127

Status
Consolidated with 1:14-cv-01317 (D. Del.); 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 in Lead Case (1:14-cv-01317; Fed. Cir. 2017-1480); Petition for Rehearing En Banc Denied; Supreme Court Writ of Certiorari Denied; On Remand Jury Found Three Claims Not Invalid and Two Claims Invalid for Lack of Written Description, Defendant's Motion for JMOL Denied as to Written Description but Granted as to Enablement, Motion for New Trial Denied, Motion for Permanent Injunction Denied as Moot because Claims Not Enabled; Federal Circuit Appeal Affirmed, Request for Panel and En Banc Rehearing 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; 20-1074

Supreme Court Appeal(s)
18-127

Status
Consolidated with 1:14-cv-01317 (D. Del.); 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 in Lead Case (1:14-cv-01317; Fed. Cir. 2017-1480); Petition for Rehearing En Banc Denied; Supreme Court Writ of Certiorari Denied; On Remand Jury Found Three Claims Not Invalid and Two Claims Invalid for Lack of Written Description, Defendant's Motion for JMOL Denied as to Written Description but Granted as to Enablement, Motion for New Trial Denied, Motion for Permanent Injunction Denied as Moot because Claims Not Enabled; Federal Circuit Appeal Affirmed, Request for Panel and En Banc Rehearing 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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