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Last Updated: December 11, 2019

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Baloxavir marboxil - Generic Drug Details

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What are the generic sources for baloxavir marboxil and what is the scope of freedom to operate?

Baloxavir marboxil is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baloxavir marboxil has ninety-three patent family members in twenty-nine countries.

Two suppliers are listed for this compound.

Summary for baloxavir marboxil
International Patents:93
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 8
Clinical Trials: 6
Patent Applications: 3
DailyMed Link:baloxavir marboxil at DailyMed
Recent Clinical Trials for baloxavir marboxil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of WashingtonPhase 4
ShionogiN/A
Hoffmann-La RocheN/A

See all baloxavir marboxil clinical trials

Synonyms for baloxavir marboxil
(((12aR)-12-((11S)-7,8-Difluoro-6,11-dihydrodibenzo(b,E)thiepin-11-yl)-6,8-dioxo-3,4,6,8,12,12ahexahydro-1H-(1,4)oxazino(3,4-C)pyrido(2,1-F)(1,2,4)triazin-7-yl)oxy)methyl methyl carbonate
(((R)-12-((S)-7,8-difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl)-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl)oxy)methyl methyl carbonate
1985606-14-1
505CXM6OHG
Baloxavir marboxil (JAN/USAN/INN)
Baloxavir marboxil [INN]
Carbonic acid, (((12aR)-12-((11S)-7,8-difluoro-6,11-dihydrodibenzo(b,E)thiepin-11-yl)-3,4,6,8,12,12a-hexahydro-6,8-dioxo-1H-(1,4)oxazino(3,4-C)pyrido(2,1-F)(1,2,4)triazin-7-yl)oxy)methyl methyl ester
CS-0030527
D11021
EX-A1867
HY-109025
SCHEMBL20108731
UNII-505CXM6OHG
Xofluza (TN)

US Patents and Regulatory Information for baloxavir marboxil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-001 Oct 24, 2018 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-001 Oct 24, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-001 Oct 24, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Dow
Colorcon
Johnson and Johnson
Merck

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