Albumin (Human) Products
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Status – approved; marketed
Organizations involved:
Baxter Hyland Immuno – Manuf.; World mark.
Talecris Biotherapeutics Inc. – Manuf.; USA mark.
NPS Pharmaceuticals Inc – Parent
Bayer Schering AG – Intl. mark.
CSL Bioplasma, Inc. – USA mark.
CSL Bioplasma AG – Manuf.; Intl. mark.; Parent
CSL Ltd. – Parent
Kedrion, S.p.A – Manuf.; Intl. mark.
Grifols Biologicals Inc. – Manuf.; USA mark.
Instituto Grifols, S.A. – Manuf.; Intl. mark.; Parent
Probitas S.A. – Parent
Octapharma USA, Inc. – USA mark.
Octapharma AG – Manuf.; Parent
Biotest AG – Manuf.; EU mark.
Massachusetts Biological Labs. (MBL) – Manuf.
Central Lab. of the Netherlands Red Cross – Former
Harvard University – R&D; Tech.
Bayer Corp. – Former
Cross ref.: See the entry for Plasma (#798), from which this product is derived. See also the entry (#101) for Albumin, rDNA or recombinant human albumin.
Description: Albumin (Human) is a liquid solution containing 96% albumin protein obtained from fractionated pooled human blood Plasma. The source material of Albumin (Human) is Plasma recovered from Whole Blood, Source Plasma, or from placentas from screened healthy donors (mothers havin
... truncated (just the beginning)
Annual sales (2008; $million): (reserved for subscribers)
Annual sales (2009; $million): (reserved for subscribers)
Annual sales (2010; $million): (reserved for subscribers)
Annual sales (2011; $million): (reserved for subscribers)
Annual sales (2012; $million): (reserved for subscribers)
Index Terms:
Companies involvement:
Partial monograph text:
703 Albumin (Human) Products
Nomenclature:
Albumin [BIO]
Albuminar [TR]
Albutein [TR]
Kedbumin [TR]
Plasmabumin [TR]
Albumin (Human) [FDA after 1/29/1985]
Normal Serum Albumin [FDA prior to 1/29/1985]
Albumin (Human) [USAN; INN]
HSA [SY]
human serum albumin (HSA) [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1941
Annual sales (2007; $million): (reserved for subscribers)
Biosimilars/biobetters Data
U.S.A.
European Union (EU)
Biosimilars/biobetters-related U.S. Patents: Reserved for subscribers]
U.S. Patent Expiration Year: Reserved for subscribers
U.S. Biosimilars Data Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Launchability Year: Reserved for subscribers
U.S. Biobetters Launchability Year: Reserved for subscribers
Biosimilars/biobetters-related EU Patents: Reserved for subscribers
EU Patent Expiration Year: Reserved for subscribers
EU Biosimilars Data Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Launchability Year: Reserved for subscribers
EU Biobetters Launchability Year: Reserved for subscribers
biopharmaceutical products
blepharospasm
blood products
human materials used<!-- humansource -->
heat treatment (pasteurization)
Plasma (Human)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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