Betaseron® (interferon beta-1b)

BL 103471

Betaseron® (interferon beta-1b)

BL 103471

U.S. License Holder:

Bayer Healthcare Pharms

Date of License:

July-23-1993

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


BETASERON (interferon beta-1b) is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
7,588,755 (DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-Like Polypeptides)

Plaintiffs
Bayer HealthCare Pharmaceuticals Inc.

Defendants
Biogen IDEC, Inc.; Biogen MA, Inc.; Ares Trading; Consolidated Defendants: EMD Serono Inc.; Novartis Pharmaceuticals Corp.; Pfizer Inc.

Federal Circuit Appeal(s)
19-1133

Status
Jury Verdict (Claims infringed and anticipated); JMOL Motions Granted for New Trial; Case Ongoing; Federal Circuit Appeal Pending

BPCIA
N

U.S. Patent Nos.
7,588,755 (DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-Like Polypeptides)

Plaintiffs
Biogen MA, Inc.

Defendants
Bayer HealthCare Pharmaceuticals Inc.; EMD Serono, Inc.; Novartis Pharmaceuticals Corp.; Pfizer Inc.

Federal Circuit Appeal(s)
19-1133

Status
Consolidated with 2:10-cv-02734 (D.N.J.); Federal Circuit Appeal Pending

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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