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Last Updated: September 29, 2020

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RUKOBIA Drug Profile

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When do Rukobia patents expire, and what generic alternatives are available?

Rukobia is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-eight patent family members in twenty-nine countries.

The generic ingredient in RUKOBIA is fostemsavir tromethamine. One supplier is listed for this compound. Additional details are available on the fostemsavir tromethamine profile page.

US ANDA Litigation and Generic Entry Outlook for Rukobia

Rukobia will be eligible for patent challenges on July 2, 2024. 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 November 19, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RUKOBIA
International Patents:38
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Drug Prices: Drug price information for RUKOBIA
DailyMed Link:RUKOBIA at DailyMed
Drug patent expirations by year for RUKOBIA
Drug Prices for RUKOBIA

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Generic Entry Opportunity Date for RUKOBIA
Generic Entry Date for RUKOBIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;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.

US Patents and Regulatory Information for RUKOBIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 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:

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