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-six 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
Summary for XENLETA
International Patents: | 86 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 20 |
Clinical Trials: | 2 |
Patent Applications: | 35 |
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
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
Sponsor | Phase |
---|---|
Nabriva Therapeutics AG | Phase 1 |
Nabriva Therapeutics AG | Phase 1/Phase 2 |
University of Washington | Phase 1/Phase 2 |
Pharmacology for XENLETA
Drug Class | Anti-coagulant Calculi Dissolution Agent |
Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
Physiological Effect | Decreased Coagulation Factor Activity |
Anatomical Therapeutic Chemical (ATC) Classes for XENLETA
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for the preparation of pleuromutilins
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting XENLETA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
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 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Patent: 11257938
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 23486
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0809023
Estimated Expiration: ⤷ Try a Trial
Patent: 2012029982
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 78795
Estimated Expiration: ⤷ Try a Trial
Patent: 99029
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1668738
Estimated Expiration: ⤷ Try a Trial
Patent: 3080083
Estimated Expiration: ⤷ Try a Trial
Patent: 4211624
Estimated Expiration: ⤷ Try a Trial
Patent: 5111117
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0110869
Estimated Expiration: ⤷ Try a Trial
Patent: 0220201
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 17482
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 37143
Estimated Expiration: ⤷ Try a Trial
Patent: 80874
Estimated Expiration: ⤷ Try a Trial
Patent: 76505
Estimated Expiration: ⤷ Try a Trial
Patent: 99356
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8707
Estimated Expiration: ⤷ Try a Trial
Patent: 3273
Estimated Expiration: ⤷ Try a Trial
Patent: 0970868
Estimated Expiration: ⤷ Try a Trial
Patent: 1291370
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 72618
Estimated Expiration: ⤷ Try a Trial
Patent: 37143
Estimated Expiration: ⤷ Try a Trial
Patent: 80874
Estimated Expiration: ⤷ Try a Trial
Patent: 99904
Estimated Expiration: ⤷ Try a Trial
Patent: 76505
Estimated Expiration: ⤷ Try a Trial
Patent: 99356
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 0200038
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 40185
Estimated Expiration: ⤷ Try a Trial
Patent: 53006
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 35861
Estimated Expiration: ⤷ Try a Trial
Patent: 57587
Estimated Expiration: ⤷ Try a Trial
Patent: 100001
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0440
Estimated Expiration: ⤷ Try a Trial
Patent: 2999
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 79114
Estimated Expiration: ⤷ Try a Trial
Patent: 93651
Estimated Expiration: ⤷ Try a Trial
Patent: 38021
Estimated Expiration: ⤷ Try a Trial
Patent: 01742
Estimated Expiration: ⤷ Try a Trial
Patent: 10522143
Estimated Expiration: ⤷ Try a Trial
Patent: 13528162
Estimated Expiration: ⤷ Try a Trial
Patent: 14159416
Estimated Expiration: ⤷ Try a Trial
Patent: 16210804
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 2020531
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 8916
Estimated Expiration: ⤷ Try a Trial
Patent: 4666
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 7176
Estimated Expiration: ⤷ Try a Trial
Patent: 12013645
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 314
Estimated Expiration: ⤷ Try a Trial
Patent: 332
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1086
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9011
Estimated Expiration: ⤷ Try a Trial
Patent: 3804
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 21002
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 37143
Estimated Expiration: ⤷ Try a Trial
Patent: 76505
Estimated Expiration: ⤷ Try a Trial
Patent: 99356
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 37143
Estimated Expiration: ⤷ Try a Trial
Patent: 80874
Estimated Expiration: ⤷ Try a Trial
Patent: 76505
Estimated Expiration: ⤷ Try a Trial
Patent: 99356
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 5104
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 37143
Estimated Expiration: ⤷ Try a Trial
Patent: 99356
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0905590
Estimated Expiration: ⤷ Try a Trial
Patent: 1208056
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1478593
Estimated Expiration: ⤷ Try a Trial
Patent: 1935333
Estimated Expiration: ⤷ Try a Trial
Patent: 090123882
Estimated Expiration: ⤷ Try a Trial
Patent: 130079406
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 75503
Estimated Expiration: ⤷ Try a Trial
Patent: 20459
Estimated Expiration: ⤷ Try a Trial
Patent: 59729
Estimated Expiration: ⤷ Try a Trial
Patent: 09198
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 06657
Estimated Expiration: ⤷ Try a Trial
Patent: 85073
Estimated Expiration: ⤷ Try a Trial
Patent: 0904402
Estimated Expiration: ⤷ Try a Trial
Patent: 1209026
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 09000347
Estimated Expiration: ⤷ Try a Trial
Patent: 12000506
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1802636
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 836
Estimated Expiration: ⤷ Try a Trial
Patent: 8378
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
South Africa | 200905590 | Pleuromutilin derivatives for the treatment of diseases mediated by microbes | ⤷ Try a Trial |
Mexico | PA02012828 | DERIVADOS DE PLEUROMUTILINA QUE TIENEN ACTIVIDAD ANTIBACTERIANA. (PLEUROMUTILIN DERIVATIVES HAVING ANTIBACTERIAL ACTIVITY.) | ⤷ Try a Trial |
Malaysia | 148916 | PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES | ⤷ Try a Trial |
Singapore | 185104 | PROCESS FOR THE PREPARATION OF PLEUROMUTILINS | ⤷ Try a Trial |
Malaysia | 164666 | Process for the preparation of Pleuromutilins | ⤷ Try a Trial |
Japan | 4255282 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XENLETA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2137143 | 132020000000167 | Italy | ⤷ Try a Trial | PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728 |
2137143 | LUC00178 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728 |
2137143 | PA2020531 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727 |
2137143 | 301086 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEFAMULINE, ALSMEDE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1457 20200728 |
2137143 | 2021C/501 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LEFAMULINE, ZOUTEN EN SOLVATEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728 |
2137143 | 122020000080 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEFAMULIN, DESSEN SALZE UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/20/1457 20200727 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |