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Last Updated: January 25, 2020

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XOFLUZA Drug Profile

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When do Xofluza patents expire, and when can generic versions of Xofluza launch?

Xofluza is a drug marketed by Genentech Inc and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-six patent family members in thirty countries.

The generic ingredient in XOFLUZA is baloxavir marboxil. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.

US ANDA Litigation and Generic Entry Outlook for Xofluza

Xofluza will be eligible for patent challenges on October 24, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 27, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XOFLUZA
International Patents:96
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Clinical Trials: 3
Drug Prices: Drug price information for XOFLUZA
DailyMed Link:XOFLUZA at DailyMed
Drug patent expirations by year for XOFLUZA
Drug Prices for XOFLUZA

See drug prices for XOFLUZA

Generic Entry Opportunity Date for XOFLUZA
Generic Entry Date for XOFLUZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XOFLUZA

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

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

See all XOFLUZA clinical trials

US Patents and Regulatory Information for XOFLUZA

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   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 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 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:

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