Antithrombin III (Human) – ATnativ; AT-III
Status – FDA approval withdrawn; marketed internationally
Organizations involved:
Octapharma AB – Manuf.; Tech.; Intl. Mark.
Pharmacia & Upjohn AB – Former
Pharmacia Corp. – Former
Pharmacia AB – Former
Kabi Pharmacia AB – Former
Biovitrum AB – Former
Kabivitrum AB – R&D; Tech.; Former
Cross ref: See the Antithrombin III Products entry (#706) and the other AT-III product entry.
Description: See the entries for Antithrombin-III Products and for AT-III from Talacris Biotherapeutics (Thrombate III) (#707), which is similar to this product. Based on Kabi having received a patent extension based on FDA review, isolation and purification of AT-III likely involved cross-linked sulfated carbohydrate gel chromatography.
Nomenclature: Antithrombin III/Octapharma [BIO]; ATnativ [TR]; Antithrombin III (Human) [FDA]; Antithrombin III [CAS INN BAN]; 52014-67-2 [CAS RN]; 90170-80-2 [CAS RN]; AT-III [SY]; Heparin cofactor B [SY]; Atenotiv [SY]; heparin cofactor I [SY]; EINECS 232-568-2; EINECS 290-516-4 [EINECS]
Companies.: ATnativ was developed and manufactured by Kabi-Vitrum AB, which became Pharmacia & Upjohn AB, which became Pharmacia AB, which became Biovi-trum AB, with this establishment recently acquired by Octapharma AG, CBER/FDA est. no. 1220 (formerly est. no. 0325). AT-nativ was formerly marketed in the U.S. by Pharmacia Corp., formerly Pharmacia & Upjohn Co. (prior to Pharmacia Corp.’s recent merger into Pfizer).
ATnativ is currently marketed in many countries by Octaphama AG, but not the U.S.
FDA class: Biologic PLA
Approvals: Date = 19891213; first approval, PLA 84-0502, ELA 85-0485; granted to KabiVitrum AB (est. no. 0325); orphan designation (granted 2/8/1985; expired 12/13/1996)
Date = 19911001; license revoked from KabiVitrum on Oct. 1, 1991, and granted (reissued) to Kabi Pharmacia AB
Date = 19970211; license revoked from Kabi Pharmacia AB and granted (reissued) to Pharmacia & Upjohn AB
Indications: for replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli
Status: The BLA was voluntarily withdrawn in recent years. The product is still approved and marketed European and other countries.
Tech. transfer: Kabi received U.S. patents including 3,842,061 covering methods for isolation of AT-III by adsorption on cross-linked sulfated carbohydrate gels, e.g., dextran, heparin, chondroitin and agarose. Based on time during FDA regulatory review (under 35 USC §156), the expiration date of this patent was extended five years (the maximum), from Oct. 15, 1991 to Oct. 15, 1996. Biovitrum AB has received other AT-III-related patents including U.S. 6,451,978, “Purification of antithrombin-III,” describing AT-III and isoforms purification using a cation exchange gel attached to the gel matrix via a linear polymer chain
Companies involvement:
Full monograph
708 Antithrombin III/Octapharma
Nomenclature:
Antithrombin III/Octapharma [BIO]
Atnativ [TR]
Antithrombin III (Human) [FDA]
Antithrombin III [CAS INN BAN]
52014-67-2 [CAS RN]
90170-80-2 [CAS RN]
9000-94-6 [CAS RN]
AT-III [SY]
Atenotiv [SY]
heparin cofactor B [SY]
heparin cofactor I [SY]
EINECS 232-568-2 [EINECS]
EINECS 290-516-4 [EINECS]
FDA Class: Biologic PLA
Year of approval (FDA) = 1989
Date of 1st FDA approval = 19891213
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
blood products
human materials used<!-- humansource -->
Albumin (Human)
carbodiimide (EDAC)
heat treatment (pasteurization)
Plasma (Human)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
orphan status
Park-William no. 8, Corynebacterium diphtheriae
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM001 Marketed Product in EU
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