Epogen® / Procrit® (epoetin alfa)

BL 103234

Epogen® / Procrit® (epoetin alfa)

BL 103234

U.S. License Holder:


Date of License:


Last Update:


approved_indications FDA-Approved Indications

EPOGEN / PROCRIT (epoetin alfa) is an erythropoiesis-stimulating agent (ESA) indicated for:

Treatment of anemia due to:

Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis;

Zidovudine in patients with Human Immunodeficiency Virus- (HIV) infection;

The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy;

Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

approved_indications aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Retacrit®: Hospira/Pfizer (May-2018)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Abseamed (Medice Arzneimittel Pütter) (August-2007)
Binocrit (Sandoz) (August-2007)
Epoetin alfa Hexal (Hexal) (August-2007)
Retacrit (epoetin zeta) (Hospira) (December-2007)
Silapo (epoetin zeta) (STADA) (December-2007)

Biosimilars Approved In Australia

Novicrit (epoetin lambda) (Sandoz) (January-2010)

Biosimilars Approved In Japan

Epoetin alfa BS (JCR Pharmaceuticals) (January-2010)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
6,747,002 (Pharmacokinetic and Pharmacodynamic Modeling of Erythropoietin Administration)

Patent Owner
Janssen Pharmaceuticals, Inc.; Ortho-McNeil Pharmaceutical, Inc.

Hospira, Inc.

§ 102 Challenge
Y: Claims 1-7, 12, 14-22, 24, 25, 27, 28

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-7, 12, 14-28

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (All Challenged Claims Disclaimed Prior to Institution Decision)

IPR Status
IPR Terminated Prior to Institution Decision (Patent Owner Disclaimed All Challenged Claims)

approved_indications U.S. Patent Litigations


Case No(s):

U.S. Patent Nos.
5,856,298 (Erythropoietin Isoforms) 5,756,349 (Production of Erythropoietin)

Amgen Inc.; Amgen Manufacturing, Ltd.

Hospira, Inc.; GlaxoSmithKline LLC

Federal Circuit Appeal(s)
16-2179 19-1067 (Final Judgment) 19-1102 (Cross Appeal) (consolidated with 19-1067)

District Court Case Terminated (Jury Verdict: '298 Patent Claims 24 and 27 Valid and Infringed, '349 Patent Not Infringed, Damages Award); Federal Circuit Appeal on Motion to Compel Dismissed and Petition for Writ of Mandamus Denied; Federal Circuit Appeal of Final Judgment Affirmed, Petition for En Banc Rehearing Denied



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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