US 12,403,183 B2
Factor VIII polypeptide formulations
Kevin Maloney, Waltham, MA (US); Daniel Gage, Waltham, MA (US); and Ahmad Abdul-Fattah, Waltham, MA (US)
Assigned to BIOVERATIV THERAPEUTICS INC., Waltham, MA (US)
Filed by BIOVERATIV THERAPEUTICS INC., Waltham, MA (US)
Filed on Aug. 14, 2020, as Appl. No. 16/993,979.
Application 16/993,979 is a division of application No. 15/455,043, filed on Mar. 9, 2017, granted, now 10,786,554.
Application 15/455,043 is a division of application No. 14/213,180, filed on Mar. 14, 2014, granted, now 9,623,088, issued on Apr. 18, 2017.
Claims priority of provisional application 61/897,742, filed on Oct. 30, 2013.
Claims priority of provisional application 61/879,955, filed on Sep. 19, 2013.
Claims priority of provisional application 61/876,927, filed on Sep. 12, 2013.
Claims priority of provisional application 61/863,860, filed on Aug. 8, 2013.
Claims priority of provisional application 61/839,477, filed on Jun. 26, 2013.
Claims priority of provisional application 61/829,884, filed on May 31, 2013.
Claims priority of provisional application 61/817,085, filed on Apr. 29, 2013.
Claims priority of provisional application 61/800,293, filed on Mar. 15, 2013.
Prior Publication US 2021/0069300 A1, Mar. 11, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/37 (2006.01); C07K 14/755 (2006.01); C07K 16/28 (2006.01)
CPC A61K 38/37 (2013.01) [C07K 14/755 (2013.01); C07K 16/2833 (2013.01); C07K 2319/30 (2013.01)] 44 Claims
 
1. A pharmaceutical composition comprising:
a. a chimeric polypeptide comprising a FVIII portion and an Fc region;
b. about 10 mg/mL to about 25 mg/mL sucrose;
c. about 10 mg/mL to about 13 mg/mL sodium chloride (NaCl);
d. about 0.75 mg/mL to about 2.25 mg/mL L-histidine;
e. about 5 mM to about 10 mM calcium chloride; and
f. about 0.08 mg/mL to about 0.25 mg/mL polysorbate 20 or polysorbate 80.