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Last Updated: January 20, 2020

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XENLETA Drug Profile

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Which patents cover Xenleta, and when can generic versions of Xenleta launch?

Xenleta is a drug marketed by Nabriva and is included in two NDAs. There are four patents protecting this drug.

This drug has one hundred and nine patent family members in thirty-nine countries.

The generic ingredient in XENLETA is lefamulin acetate. One supplier is listed for this compound. Additional details are available on the lefamulin acetate profile page.

US ANDA Litigation and Generic Entry Outlook for Xenleta

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Xenleta will be eligible for patent challenges on August 19th, 2023. 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 August 19th, 2029. This may change due to patent challenges or generic licensing.

Summary for XENLETA
International Patents:109
US Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Drug Prices: Drug price information for XENLETA
DailyMed Link:XENLETA at DailyMed
Drug patent expirations by year for XENLETA
Drug Prices for XENLETA

See drug prices for XENLETA

Generic Entry Opportunity Date for XENLETA
Generic Entry Dates for XENLETA*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
NDA:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for XENLETA*:
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.

US Patents and Regulatory Information for XENLETA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes   Start Trial   Start Trial   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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