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Last Updated: August 8, 2022

XENLETA Drug Patent Profile


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

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

This drug has eighty-four patent family members in thirty-three countries.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

DrugPatentWatch® Generic Entry Outlook for Xenleta

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

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Summary for XENLETA
Drug patent expirations by year for XENLETA
Drug Prices for XENLETA

See drug prices for XENLETA

DrugPatentWatch® Estimated 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.

Recent Clinical Trials for XENLETA

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

SponsorPhase
Nabriva Therapeutics AGPhase 1
University of WashingtonPhase 1/Phase 2
Nabriva Therapeutics AGPhase 1/Phase 2

See all XENLETA clinical trials

US Patents and Regulatory Information for XENLETA

XENLETA is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XENLETA is See Plans and Pricing.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XENLETA

Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for the preparation of pleuromutilins
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XENLETA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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

Expired US Patents for XENLETA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 See Plans and Pricing See Plans and Pricing
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for XENLETA

When does loss-of-exclusivity occur for XENLETA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08229609
Estimated Expiration: See Plans and Pricing

Patent: 11257938
Estimated Expiration: See Plans and Pricing

Austria

Patent: 3486
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0809023
Estimated Expiration: See Plans and Pricing

Patent: 2012029982
Estimated Expiration: See Plans and Pricing

Canada

Patent: 78795
Estimated Expiration: See Plans and Pricing

Patent: 99029
Estimated Expiration: See Plans and Pricing

China

Patent: 1668738
Estimated Expiration: See Plans and Pricing

Patent: 3080083
Estimated Expiration: See Plans and Pricing

Patent: 4211624
Estimated Expiration: See Plans and Pricing

Patent: 5111117
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0110869
Estimated Expiration: See Plans and Pricing

Patent: 0220201
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17482
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 37143
Estimated Expiration: See Plans and Pricing

Patent: 80874
Estimated Expiration: See Plans and Pricing

Patent: 76505
Estimated Expiration: See Plans and Pricing

Patent: 99356
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8707
Estimated Expiration: See Plans and Pricing

Patent: 3273
Estimated Expiration: See Plans and Pricing

Patent: 0970868
Estimated Expiration: See Plans and Pricing

Patent: 1291370
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 72618
Estimated Expiration: See Plans and Pricing

Patent: 37143
Estimated Expiration: See Plans and Pricing

Patent: 80874
Estimated Expiration: See Plans and Pricing

Patent: 99904
Estimated Expiration: See Plans and Pricing

Patent: 76505
Estimated Expiration: See Plans and Pricing

Patent: 99356
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 40185
Estimated Expiration: See Plans and Pricing

Patent: 53006
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 35861
Estimated Expiration: See Plans and Pricing

Patent: 100001
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0440
Estimated Expiration: See Plans and Pricing

Patent: 2999
Estimated Expiration: See Plans and Pricing

Japan

Patent: 79114
Estimated Expiration: See Plans and Pricing

Patent: 93651
Estimated Expiration: See Plans and Pricing

Patent: 38021
Estimated Expiration: See Plans and Pricing

Patent: 01742
Estimated Expiration: See Plans and Pricing

Patent: 10522143
Estimated Expiration: See Plans and Pricing

Patent: 13528162
Estimated Expiration: See Plans and Pricing

Patent: 14159416
Estimated Expiration: See Plans and Pricing

Patent: 16210804
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 2020531
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8916
Estimated Expiration: See Plans and Pricing

Patent: 4666
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7176
Estimated Expiration: See Plans and Pricing

Patent: 12013645
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 314
Estimated Expiration: See Plans and Pricing

Patent: 332
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1086
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9011
Estimated Expiration: See Plans and Pricing

Patent: 3804
Estimated Expiration: See Plans and Pricing

Norway

Patent: 21002
Estimated Expiration: See Plans and Pricing

Poland

Patent: 37143
Estimated Expiration: See Plans and Pricing

Patent: 76505
Estimated Expiration: See Plans and Pricing

Patent: 99356
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 37143
Estimated Expiration: See Plans and Pricing

Patent: 80874
Estimated Expiration: See Plans and Pricing

Patent: 76505
Estimated Expiration: See Plans and Pricing

Patent: 99356
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 5104
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 37143
Estimated Expiration: See Plans and Pricing

Patent: 99356
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0905590
Estimated Expiration: See Plans and Pricing

Patent: 1208056
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1478593
Estimated Expiration: See Plans and Pricing

Patent: 1935333
Estimated Expiration: See Plans and Pricing

Patent: 090123882
Estimated Expiration: See Plans and Pricing

Patent: 130079406
Estimated Expiration: See Plans and Pricing

Spain

Patent: 75503
Estimated Expiration: See Plans and Pricing

Patent: 20459
Estimated Expiration: See Plans and Pricing

Patent: 59729
Estimated Expiration: See Plans and Pricing

Patent: 09198
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 06657
Estimated Expiration: See Plans and Pricing

Patent: 85073
Estimated Expiration: See Plans and Pricing

Patent: 0904402
Estimated Expiration: See Plans and Pricing

Patent: 1209026
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 09000347
Estimated Expiration: See Plans and Pricing

Patent: 12000506
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1802636
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 836
Estimated Expiration: See Plans and Pricing

Patent: 8378
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XENLETA around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1117482 See Plans and Pricing
Russian Federation 2003103101 See Plans and Pricing
Spain 2313969 See Plans and Pricing
South Korea 20090123882 PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES See Plans and Pricing
Norway 329091 See Plans and Pricing
Japan 5479114 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XENLETA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137143 301086 Netherlands See Plans and Pricing PRODUCT NAME: LEFAMULINE, ALSMEDE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1457 20200728
2137143 2021C/501 Belgium See Plans and Pricing PRODUCT NAME: LEFAMULINE, ZOUTEN EN SOLVATEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728
2137143 122020000080 Germany See Plans and Pricing PRODUCT NAME: LEFAMULIN, DESSEN SALZE UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/20/1457 20200727
2137143 20C1053 France See Plans and Pricing PRODUCT NAME: LEFAMULINE; NAT. REGISTRATION NO/DATE: EU/1/20/1457 20200728; FIRST REGISTRATION: FR - EU/1/20/1457 20200728
2137143 2090054-4 Sweden See Plans and Pricing PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/20/1457 20200728
2137143 54/2020 Austria See Plans and Pricing PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Harvard Business School
Medtronic
Johnson and Johnson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.