Activase® / Cathflo® Activase® (alteplase)

BL 103172

Activase® / Cathflo® Activase® (alteplase)

BL 103172

U.S. License Holder:

Genentech

Date of License:

November-13-1987

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

ACTIVASE (alteplase) is a tissue plasminogen activator (tPA) indicated for the treatment of:

Acute Ischemic Stroke (AIS);

Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure;

Acute Massive Pulmonary Embolism (PE) for lysis.

CATHFLO ACTIVASE (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

3:08-cv-04909 (N.D. Cal.)

U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)

Plaintiffs
Sanofi-Aventis Deutschland GmbH; Sanofi-Aventis U.S. LLC; Sanofi-Aventis U.S. Inc.

Defendants
Biogen IDEC, Inc.; Genentech, Inc.

Federal Circuit Appeal(s)
12-1454

Status
Case Terminated

BPCIA
N

3:09-cv-04919 (N.D. Cal.)

U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)

Plaintiffs
Sanofi-Aventis Deutschland GmbH

Defendants
Biogen IDEC, Inc.; Genentech, Inc.

Federal Circuit Appeal(s)
12-1454

Status
Case Terminated

BPCIA
N

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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