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-seven patent family members in thirty-four 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.
DrugPatentWatch® Generic Entry Outlook for Xenleta
Xenleta was eligible for patent challenges on August 19, 2023.
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
| International Patents: | 87 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 2 |
| Patent Applications: | 30 |
| Drug Prices: | Drug price information for XENLETA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XENLETA |
| What excipients (inactive ingredients) are in XENLETA? | XENLETA excipients list |
| DailyMed Link: | XENLETA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Recent Clinical Trials for XENLETA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nabriva Therapeutics AG | Phase 1 |
| University of Washington | Phase 1/Phase 2 |
| Nabriva Therapeutics AG | Phase 1/Phase 2 |
Pharmacology for XENLETA
| Drug Class | Pleuromutilin Antibacterial Anti-coagulant Calculi Dissolution Agent |
| Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
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 ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process for the preparation of pleuromutilins
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting XENLETA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Estimated Expiration: ⤷ Sign Up
Patent: 11257938
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 23486
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0809023
Patent: DERIVADOS DE PLEUROMUTILINA PARA O TRATAMENTO DE DOENÇAS MEDIADAS POR MICRÓBIOS
Estimated Expiration: ⤷ Sign Up
Patent: 2012029982
Patent: processo para a preparação de pleuromutilinas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 78795
Patent: DERIVES DE PLEUROMUTILINE POUR LE TRAITEMENT DE MALADIES TRANSMISES PAR DES MICROBES (PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES)
Estimated Expiration: ⤷ Sign Up
Patent: 99029
Patent: PROCEDE POUR LA PREPARATION DE PLEUROMUTILINES (PROCESS FOR THE PREPARATION OF PLEUROMUTILINS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1668738
Patent: Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Estimated Expiration: ⤷ Sign Up
Patent: 3080083
Patent: Process for the preparation of pleuromutilins
Estimated Expiration: ⤷ Sign Up
Patent: 4211624
Patent: PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES
Estimated Expiration: ⤷ Sign Up
Patent: 5111117
Patent: Process for the preparation of pleuromutilins
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0110869
Estimated Expiration: ⤷ Sign Up
Patent: 0220201
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 17482
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 37143
Estimated Expiration: ⤷ Sign Up
Patent: 80874
Estimated Expiration: ⤷ Sign Up
Patent: 76505
Estimated Expiration: ⤷ Sign Up
Patent: 99356
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8707
Patent: ПРОИЗВОДНЫЕ ПЛЕВРОМУТИЛИНА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ОПОСРЕДУЕМЫХ МИКРОБАМИ (PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES)
Estimated Expiration: ⤷ Sign Up
Patent: 3273
Patent: СПОСОБ ПОЛУЧЕНИЯ ПЛЕУРОМУТИЛИНОВ (PROCESS FOR THE PREPARATION OF PLEUROMUTILINS)
Estimated Expiration: ⤷ Sign Up
Patent: 0970868
Patent: ПРОИЗВОДНЫЕ ПЛЕВРОМУТИЛИНА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ОПОСРЕДУЕМЫХ МИКРОБАМИ
Estimated Expiration: ⤷ Sign Up
Patent: 1291370
Patent: СПОСОБ ПОЛУЧЕНИЯ ПЛЕУРОМУТИЛИНОВ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 72618
Patent: Dérivés de pleuromutilin pour le traitement des maladies médiées par des microbes (Pleuromutilin derivatives for the treatment of diseases mediated by microbes)
Estimated Expiration: ⤷ Sign Up
Patent: 37143
Patent: DÉRIVÉS DE PLEUROMUTILINE POUR LE TRAITEMENT DE MALADIES TRANSMISES PAR DES MICROBES (PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES)
Estimated Expiration: ⤷ Sign Up
Patent: 80874
Patent: Dérivés de pleuromutilin pour le traitement des maladies médiées par des microbes (Pleuromutilin derivatives for the treatment of diseases mediated by microbes)
Estimated Expiration: ⤷ Sign Up
Patent: 99904
Patent: Procédé de préparation de pleuromutilines (Process for the preparation of pleuromutilins)
Estimated Expiration: ⤷ Sign Up
Patent: 76505
Patent: FORME CRYSTALLINE D'UNE PLEUROMUTILINE (CRYSTALLINE FORM OF A PLEUROMUTILIN)
Estimated Expiration: ⤷ Sign Up
Patent: 99356
Patent: PROCÉDÉ DE PRÉPARATION DE PLEUROMUTILINES (PROCESS FOR THE PREPARATION OF PLEUROMUTILINS)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 0200038
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 40185
Patent: PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES
Estimated Expiration: ⤷ Sign Up
Patent: 53006
Patent: 製備截短側耳素的工藝 (PROCESS FOR THE PREPARATION OF PLEUROMUTILINS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 35861
Estimated Expiration: ⤷ Sign Up
Patent: 57587
Estimated Expiration: ⤷ Sign Up
Patent: 100001
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0440
Patent: תולדות פלאורומוטילין לטיפול במחלות המתווכות על ידי מיקרובים (Pleuromutilin derivatives for the treatment of diseases mediated by microbes)
Estimated Expiration: ⤷ Sign Up
Patent: 2999
Patent: תהליך להכנת פלאורומוטילינים, חומרי ביניים ותכשירים רוקחיים המכילים פלאורומוטילינים (Process for the preparation of pleuromutilins, intermediates and pharmaceutical compositions comprising pleuromutilin compounds)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 79114
Estimated Expiration: ⤷ Sign Up
Patent: 93651
Estimated Expiration: ⤷ Sign Up
Patent: 38021
Estimated Expiration: ⤷ Sign Up
Patent: 01742
Estimated Expiration: ⤷ Sign Up
Patent: 10522143
Estimated Expiration: ⤷ Sign Up
Patent: 13528162
Estimated Expiration: ⤷ Sign Up
Patent: 14159416
Patent: PLEUROMUTILIN DERIVATIVE FOR THERAPY OF DISEASES MEDIATED BY MICROORGANISMS
Estimated Expiration: ⤷ Sign Up
Patent: 16210804
Patent: プレウロムチリン (PLEUROMUTILINS)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 2020531
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 8916
Patent: PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES
Estimated Expiration: ⤷ Sign Up
Patent: 4666
Patent: Process for the preparation of Pleuromutilins
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 7176
Patent: PROCEDIMIENTO PARA LA PREPARACION DE PLEUROMUTILINAS. (PROCESS FOR THE PREPARATION OF PLEUROMUTILINS.)
Estimated Expiration: ⤷ Sign Up
Patent: 12013645
Patent: PROCEDIMIENTO PARA LA PREPARACION DE PLEUROMUTILINAS. (PROCESS FOR THE PREPARATION OF PLEUROMUTILINS.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 314
Patent: مشتقات بلوروموتيلين لعلاج الأمراض التي تنتقل عن طريق البكتيريا.
Estimated Expiration: ⤷ Sign Up
Patent: 332
Patent: PROCÉDÉ POUR LA PRÉPARATION DE PLEUROMUTILINES
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1086
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9011
Patent: PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES
Estimated Expiration: ⤷ Sign Up
Patent: 3804
Patent: Process for the preparation of pleuromutilins
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 21002
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 37143
Estimated Expiration: ⤷ Sign Up
Patent: 76505
Estimated Expiration: ⤷ Sign Up
Patent: 99356
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 37143
Estimated Expiration: ⤷ Sign Up
Patent: 80874
Estimated Expiration: ⤷ Sign Up
Patent: 76505
Estimated Expiration: ⤷ Sign Up
Patent: 99356
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 5104
Patent: PROCESS FOR THE PREPARATION OF PLEUROMUTILINS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 37143
Estimated Expiration: ⤷ Sign Up
Patent: 99356
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0905590
Patent: Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Estimated Expiration: ⤷ Sign Up
Patent: 1208056
Patent: PROCESS FOR THE PREPARATION OF PLEUROMUTILINS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1478593
Estimated Expiration: ⤷ Sign Up
Patent: 1935333
Estimated Expiration: ⤷ Sign Up
Patent: 090123882
Patent: PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES
Estimated Expiration: ⤷ Sign Up
Patent: 130079406
Patent: PROCESS FOR THE PREPARATION OF PLEUROMUTILINS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 75503
Estimated Expiration: ⤷ Sign Up
Patent: 20459
Estimated Expiration: ⤷ Sign Up
Patent: 59729
Estimated Expiration: ⤷ Sign Up
Patent: 09198
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 06657
Estimated Expiration: ⤷ Sign Up
Patent: 85073
Estimated Expiration: ⤷ Sign Up
Patent: 0904402
Patent: Organic compounds
Estimated Expiration: ⤷ Sign Up
Patent: 1209026
Patent: Process for the preparation of pleuromutilins
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 09000347
Patent: DERIVES DE PLEUROMUTILINE POUR LE TRAITEMENT DE MALADIES TRANSMISES PAR DES MICROBES
Estimated Expiration: ⤷ Sign Up
Patent: 12000506
Patent: PROCESS FOR THE PREPARATION OF PLEUROMUTILINS
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1802636
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 836
Patent: ПРОИЗВОДНЫЕ ПЛЕВРОМУТИЛИНА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ВЫЗВАННЫХ МИКРОБАМИ;ПОХІДНІ ПЛЕВРОМУТИЛІНУ ДЛЯ ЛІКУВАННЯ ЗАХВОРЮВАНЬ, ВИКЛИКАНИХ МІКРОБАМИ (PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES)
Estimated Expiration: ⤷ Sign Up
Patent: 8378
Patent: СПОСІБ ОДЕРЖАННЯ ПЛЕУРОМУТИЛІНІВ
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Lithuania | PA2020531 | ⤷ Sign Up | |
| Eurasian Patent Organization | 201291370 | СПОСОБ ПОЛУЧЕНИЯ ПЛЕУРОМУТИЛИНОВ | ⤷ Sign Up |
| Israel | 200440 | תולדות פלאורומוטילין לטיפול במחלות המתווכות על ידי מיקרובים (Pleuromutilin derivatives for the treatment of diseases mediated by microbes) | ⤷ Sign Up |
| Portugal | 3299356 | ⤷ Sign Up | |
| Japan | 2009108088 | PLEUROMUTILIN DERIVATIVE HAVING ANTIBACTERIAL ACTIVITY | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2011146954 | ⤷ Sign Up | |
| Israel | 153839 | PLEUROMUTILIN DERIVATIVES HAVING ANTIBACTERIAL ACTIVITY | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XENLETA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2137143 | PA2020531 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727 |
| 2137143 | LUC00178 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728 |
| 2137143 | SPC/GB20/052 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LEFAMULIN, OPTIONALLY IN THE FORM OF A SALT AND/OR SOLVATE THEREOF; REGISTERED: UK EU/1/20/1457 (NI) 20200728; UK PLGB 53672/0001 20200728; UK PLGB 53672/0002 20200728 |
| 2137143 | 132020000000167 | Italy | ⤷ Sign Up | PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728 |
| 2137143 | CR 2020 00046 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEFAMULIN, SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/20/1457 20200728 |
| 2137143 | 2090054-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/20/1457 20200728 |
| 2137143 | 2020/053 | Ireland | ⤷ Sign Up | PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; NAT REGISTRATION NO/DATE: EU/1/20/1457 20200728; FIRST REGISTRATION NO/DATE: EU/1/20/1457 20200728 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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