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Last Updated: August 10, 2022

Details for Patent: 10,058,546


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Summary for Patent: 10,058,546
Title:Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof
Abstract: A pharmaceutical composition comprising Compound 1, (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide, and at least one excipient selected from: a filler, a disintegrant, a surfactant, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering the pharmaceutical composition of Compound 1 are also disclosed.
Inventor(s): Alargova; Rossitza Gueorguieva (Brighton, MA), Dunbar; Craig Antony (Needham, MA), Kadiyala; Irina Nikolaevna (Newton, MA)
Assignee: Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:15/342,999
Patent Claim Types:
see list of patent claims
Use; Composition;

Drugs Protected by US Patent 10,058,546

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No See Plans and Pricing See Plans and Pricing TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546 See Plans and Pricing
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No See Plans and Pricing See Plans and Pricing TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546 See Plans and Pricing
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No See Plans and Pricing See Plans and Pricing TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546 See Plans and Pricing
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No See Plans and Pricing See Plans and Pricing TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 10058546 See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,058,546

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 092857 See Plans and Pricing
Australia 2013290444 See Plans and Pricing
Australia 2018208694 See Plans and Pricing
Canada 2878057 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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