Claims for Patent: 10,363,253

Summary for Patent: 10,363,253

Title:	Combination products for the treatment of RSV
Abstract:	The present invention is directed to the combination of the RSV inhibiting Compound A, i.e. 3-({5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl}methyl)-1-(2,2,2-- trifluoroethyl) 1,3-dihydro-2H-imidazo[4,5-c]pyridin-2-one, and one or more RSV inhibiting Compound B selected from from ribavirin, GS-5806, MDT-637, BTA-9881, BMS-433771, YM-543403, A-60444, TMC-353121, RFI-641, CL-387626, MBX-300, AZ-27, MEDI8897, CR9501, palivizumab, 3-({5-chloro-1-[3-(methylsulfonyl)propyl]-1H-benzimidazol-2-yl}methyl)-1 cyclopropyl-1,3-dihydro-2H-imidazo[4,5-c]pyridin-2-one, 3-[[7-chloro-3-(2 ethyl-sulfonylethyl)imidazo[1,2-a]pyridin-2-yl]methyl]-1-cyclopropyl-imid- azo[4,5-c]pyridin-2 one, N-(2-fluoro-6-methylphenyl)-6-(4-(5-methyl-2-(7-oxa-2-azaspiro[3.5]nonan-- 2 yl)nicotinamido)benzoyl)-5,6-dihydro-4H-benzo[b]thieno[2,3-d]azepine-2-c- arboxamide, and 4-amino-8-[3-[[2-(3,4-dimethoxyphenyl)ethyl]amino]propyl]-6,6-dimethyl-2-- (4-methyl 3-nitrophenyl)-3H-imidazo[4,5-h]isoquinoline-7,9(6H,8H)-dione, for treating or ameliorating RSV infection. The invention further relates to the combination product of Compound A and one or more Compound B, a pharmaceutical product comprising Compound A and one or more Compound B, the use of the combination of Compound A and one or more of Compound B--or the pharmaceutical product comprising Compound A and one or more Compound B--for the treatment of RSV infection, and a method of treating or ameliorating RSV infection in a subject in need thereof comprising administering the combination of Compound A and one or more Compound B in an effective amount to said subject.
Inventor(s):	Ysebaert; Nina (Beerse, BE), Goeyvaerts; Nele Isa E. (Beerse, BE), Roymans; Dirk Andre E. (Beerse, BE), Koul; Anil (Beerse, BE)
Assignee:	Janssen Sciences Ireland Unlimited Company (Ringaskiddy, Co Cork, IE)
Application Number:	16/075,103
Patent Claims:	1. A combination comprising 3-({5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl-(methyl)-1-(2,2,2- -trifluoroethyl)-1.3-dihydro-2H-imidazo[4,5-c]pyridin-2-one, or a pharmaceutically acceptable salt thereof, as Compound A, and one or more Compound B selected from ribavirin, GS-5806, MDT-637, A-60444, AZ-27, CR9501, palivizumab, N-(2-fluoro-6-methylphenyl)-6-(4-(5-methyl-2-(7-oxa-2-azaspiro[3.5]nonan-- 2-yl)nicotinamido)-benzoyl)-5,6-dihydro-4H-benzo[b]thieno[2,3-d]azepine-2-- carboxamide, and 4-amino-8-[3-[[2-(3,4-dimethoxyphenyl)ethyl]amino]propyl]-6,6-dimethyl-2-- (4-methyl-3-nitrophenyl)-3H-imidazo[4,5h]isoquinoline-7,9(6H, 8H)-dione. 2. The combination according to claim 1 wherein Compound B is ribavirin. 3. The combination according to claim 1 wherein Compound B is GS-5806. 4. The combination according to claim 1 wherein Compound B is MDT-637. 5. The combination according to claim 1 wherein Compound B is A-60444. 6. The combination according to claim 1 wherein Compound B is a monoclonal antibody selected from CR9501, and palivizumab. 7. The combination according to claim 1 wherein Compound B is N-(2-fluoro-6-methylphenyl)-6-(4-(5-methyl-2-(7-oxa-2-azaspiro[3.5]nonan-- 2-yl)nicotinamido)benzoyl)-5,6-dihydro-4H-benzo[b]thieno[2,3-d]azepine-2-c- arboxamide. 8. The combination according to claim 1 wherein Compound B is 4-amino-8-[3-[[2-(3,4-dimethoxyphenyl)ethyl]amino]propyl]-6,6-dimethyl-2-- (4-methyl-3-nitrophenyl)-3H-imidazo[4,5-h]isoquinoline-7,9(6H,8H)-dione. 9. The combination according to claim 1 wherein the amount of Compound A and the amount of Compound B is such that a synergistic antiviral effect against RSV is obtained. 10. The combination according to claim 8 wherein the amount of Compound A ranges from 10 mg to 2500 mg and the amount of Compound B ranges from 10 mg to 2500 mg. 11. A pharmaceutical composition comprising a combination as claimed in claim 1, and a pharmaceutically acceptable carrier. 12. A method for treating or ameliorating RSV infection in a subject in need thereof comprising administering the combination of 3-({5-chloro-1-[3-(methylsulfonyl)propyl]-1 H-indol-2-yl}methyl)-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-- c]pyridin-2-one, or a pharmaceutically acceptable salt thereof, as Compound A, and one or more Compound B selected from ribavirin, GS-5806, MDT-637, A-60444, AZ-27, CR9501, palivizumab, N-(2-fluoro-6-methylphenyl)-6-(4-(5-methyl-2-(7-oxa-2-azaspiro[3.5]nonan-- 2-yl)nicotinamido)-benzoyl)-5,6-dihydro-4H-benzo[b]thieno[2,3-d]azepine-2-- carboxamide, and 4-amino-8-[3-[[2-(3,4-dimethoxyphenyl)ethyl]amino]propyl]-6,6-dimethyl-2-- (4-methyl-3-nitrophenyl)-3H-imidazo[4,5-h]isoquinoline-7,9(6H,8H)-dione. 13. The method as claimed in claim 12 wherein the combination of Compound A and one or more Compound B is formulated in a single pharmaceutical composition. 14. The method as claimed in claim 12 wherein the combination of Compound A and one or more Compound B is formulated as a separate pharmaceutical composition comprising Compound A and a separate pharmaceutical composition comprising one or more Compound B whereby the pharmaceutical compositions are administered simultaneously or sequentially.

Details for Patent 10,363,253

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	06/19/1998		2036-02-03
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	Injection	103770	07/23/2004		2036-02-03