US 11,883,389 B2
Formulations of 2-(4-chlorophenyl)-N-((2-(2,6- dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide
Ho-Wah Hui, Basking Ridge, NJ (US); and Yu Pu, East Hanover, NJ (US)
Assigned to Celgene Corporation, Summit, NJ (US)
Filed by Celgene Corporation, Summit, NJ (US)
Filed on Aug. 25, 2021, as Appl. No. 17/412,187.
Application 17/412,187 is a continuation of application No. 16/565,346, filed on Sep. 9, 2019, granted, now 11,129,821.
Application 16/565,346 is a continuation of application No. 16/040,450, filed on Jul. 19, 2018, granted, now 10,449,187, issued on Oct. 22, 2019.
Application 16/040,450 is a continuation of application No. 15/400,791, filed on Jan. 6, 2017, granted, now 10,052,315, issued on Aug. 21, 2018.
Claims priority of provisional application 62/276,756, filed on Jan. 8, 2016.
Prior Publication US 2022/0211686 A1, Jul. 7, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/454 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 39/395 (2006.01); A61K 47/12 (2006.01); A61K 47/40 (2006.01); C07K 16/00 (2006.01); A61K 47/18 (2017.01); A61K 39/00 (2006.01)
CPC A61K 31/454 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0095 (2013.01); A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 39/395 (2013.01); A61K 47/12 (2013.01); A61K 47/40 (2013.01); C07K 16/00 (2013.01); A61K 47/18 (2013.01); A61K 2039/505 (2013.01)] 23 Claims
 
1. A vial comprising a lyophilized formulation, wherein the lyophilized formulation comprises: 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide, or a stereoisomer or mixture of stereoisomers, pharmaceutically acceptable salt, tautomer, prodrug, solvate, hydrate, co-crystal, clathrate, or polymorph thereof (Compound 1), a buffer and a bulking agent.