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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 eleven 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.
Xenleta will be eligible for patent challenges on August 19, 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 19, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Generic Entry Opportunity Date for XENLETA
*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.
|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|