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Generic Xenleta Availability

Last updated on July 7, 2021.

Xenleta is a brand name of lefamulin, approved by the FDA in the following formulation(s):

XENLETA (lefamulin acetate - solution;intravenous)

  • Manufacturer: NABRIVA
    Approval date: August 19, 2019
    Strength(s): EQ 150MG BASE/15ML (EQ 10MG BASE/ML) [RLD]

XENLETA (lefamulin acetate - tablet;oral)

  • Manufacturer: NABRIVA
    Approval date: August 19, 2019
    Strength(s): EQ 600MG BASE [RLD]

Has a generic version of Xenleta been approved?

No. There is currently no therapeutically equivalent version of Xenleta available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xenleta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Pleuromutilin derivatives having antibacterial activity
    Patent 6,753,445
    Issued: June 22, 2004
    Inventor(s): Gerd; Ascher & Heinz; Berner
    Assignee(s): Biochemie Gesellschaft m.b.H.

    A compound selected from 14—O—[(cycloalkyl-sulfanyl)acetyl]mutilins; 14—O—[(cycloalkyl-alkyl-sulfanyl)acetyl] mutilins; 14—O—[(cycloalkoxy)acetyl] mutilins; and 14—O—[(cycloalkyl-alkoxy)acetyl] mutilins and its use as a pharmaceutical.

    Patent expiration dates:

    • July 9, 2021
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      Patent use: TREATMENT OF ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA CAUSED BY SUSCEPTIBLE MICROORGANISMS
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  • Pleuromutilin derivatives for the treatment of diseases mediated by microbes
    Patent 8,071,643
    Issued: December 6, 2011
    Inventor(s): Mang; Rosemarie & Heilmayer; Werner & Badegruber; Rudolf & Strickmann; Dirk B. & Novak; Rodger & Ferencic; Mathias & Bulusu; Atchyuta Rama Chandra Murty
    Assignee(s): Nabriva Therapeutics AG

    A pleuromutilin derivative compound of general formula (I)

    Patent expiration dates:

    • January 16, 2029
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      Drug substance
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  • Pleuromutilin derivatives for the treatment of diseases mediated by microbes
    Patent 8,153,689
    Issued: April 10, 2012
    Inventor(s): Mang; Rosemarie & Heilmayer; Werner & Badegruber; Rudolf & Strickmann; Dirk B. & Novak; Rodger & Ferencic; Mathias & Bulusu; Atchyuta Rama Chandra Murty
    Assignee(s): Nabriva Therapeutics AG

    Disclosed are pleuromutilin derivatives of formula (I) and their use in the treatment of diseases mediated by microbes.

    Patent expiration dates:

    • March 19, 2028
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  • Process for the preparation of pleuromutilins
    Patent 9,120,727
    Issued: September 1, 2015
    Assignee(s): NABRIVA THERAPEUTICS AG

    Process for the preparation of a compound of formula I in the form of a single stereoisomer in crystalline form, comprising deprotecting the amine group in a compound of formula IIa or in a mixture of a compound of formula IIa with a compound of formula IIb and isolating a compound of formula I from the reaction mixture; compounds and salts of compounds of formula I in crystalline form; pharmaceutical compositions comprising such salts; processes for the preparation of intermediates and intermediates in a process for the preparation of a compound of formula I.

    Patent expiration dates:

    • May 23, 2031
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Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • August 19, 2024 - NEW CHEMICAL ENTITY
    • August 19, 2029 - GENERATING ANTIBIOTIC INCENTIVES NOW

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.