Antitrypsin, alpha-1/Talecris
| This is a free, public record extracted from BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, the only biopharmaceuticals information resource/reference (at www.biopharma.com). You can view partial, truncated product monographs and most indexing terms. For further information about BIOPHARMA, see the description/flyer, published reviews, and the public Products Database and Companies Database. Contact the author/publisher regarding database subscriptions. |
Alpha-1-Proteinase Inhibitor (Human) - Prolastin; -alpha1-antitrypsin; alpha1-PI; AAT; A1P1
Status – approved; marketed
Organizations involved:
Talecris Biotherapeutics Inc. – Manuf.; R&D; Tech.; USA mark.=
Instituto Grifols, S.A. – Parent
NPS Pharmaceuticals Inc – Former
Bayer Corp. – R&D; Tech.; Former
Bayer Schering Pharma AG – Intl. mark.; Parent
Cross ref.: See Antitrypsin, alpha-1 Products (#709), and other specific Antitrypsin, alpha-1 product entries.
Description: alpha-1-Proteinase Inhibitor (Human) or Prolastin is a lyophilized (freeze-dried) formulation of alpha1-proteinase inhibitor (alpha1-antitrypsin; alpha1-PI) purified from fractionated pooled human blood Plasma, with manufacture including heat treatment (pasteurization) at 60 ± 0.5˚C as a liquid for not less than 10 hours for viral inactivation.
Prolastin has a specific activity (determined by neutralization of porcine pancreatic elastase) of ≥0.35 mg functional alpha1-proteinase inhibitor/mg protein. After reconstitution with Sterile Water for Injection, USP, for administration by intravenous infusion, Prolastin has an alpha1-proteinase inhibitor/mg protein concentration of ≥ 20 mg/mL, a pH of 6.6-7.4, sod
... 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:
711 Antitrypsin, alpha-1/Talecris
Nomenclature:
antitrypsin, alpha-1/Talacris [BIO]
Prolastin-C [TR]
Alpha-1-Proteinase Inhibitor (Human) [FDA]
alpha1-antitrypsin [CAS]
9041-92-3 [CAS RN]
A1AT [SY]
A1PI [SY]
AAT [SY]
alpha1-PI [SY]
alpha1-trypsin inhibitor [SY]
proteinase inhibitor, alpha-1 [SY]
CuttActive [TR non-U.S.]
Prolastina [TR in Spain]
NDC 0026-0601-30; NDC 0026-0601-35 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1987
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
blood products
enteric coating (tablets)
human materials used<!-- humansource -->
Albumin (Human)
alpha1-chymotrypsin
alpha1-lipoprotein
alpha2-plasmin inhibitor
antithrombin III (AT-III)
C1-esterase inhibitor
haptoglobulin
heat treatment (pasteurization)
immune globulin A (IgA)
N-succinyl-L-alanyl-L-alanyl-L-alanyl-p-nitroanilide (SA3 pNA)
Plasma (Human)
polyethylene glycol (PEG)
porcine pancreatic elastase
S-(carboxymethyl)-homocysteine
sodium chloride
sodium phosphate
Sterile Water for Injection
sucrose
virus culture
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
orphan status
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
Copyright© 2018, Biotechnology Information Institute