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Generic Koselugo Availability

Last updated on Sep 8, 2021.

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

KOSELUGO (selumetinib sulfate - capsule;oral)

  • Manufacturer: ASTRAZENECA
    Approval date: April 10, 2020
    Strength(s): EQ 10MG BASE [RLD], EQ 25MG BASE [RLD]

Has a generic version of Koselugo been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Koselugo. 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.

  • N3 alkylated benzimidazole derivatives as MEK inhibitors
    Patent 7,425,637
    Issued: September 16, 2008
    Inventor(s): Wallace; Eli M. & Lyssikatos; Joseph P. & Marlow; Allison L. & Hurley; T. Brian
    Assignee(s): Array BioPharma Inc.

    Disclosed are compounds of the Formula I and pharmaceutically acceptable salts and prodrugs thereof, wherein W, R1, R2, R7, R8, R9 and R10 are as defined in the specification. Such compounds are MEK inhibitors and useful in the treatment of hyperproliferative diseases, such as cancer and inflammation, in mammals. Also disclosed is a method of using such compounds in the treatment of hyperproliferative diseases in mammals, and pharmaceutical compositions containing such compounds.

    Patent expiration dates:

    • April 11, 2024
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      Drug substance
  • N3 alkylated benzimidazole derivatives as MEK inhibitors
    Patent 8,178,693
    Issued: May 15, 2012
    Inventor(s): Wallace; Eli M. & Lyssikatos; Joseph P. & Marlow; Allison L. & Hurley; T. Brian
    Assignee(s): Array Biopharma Inc.

    Disclosed are compounds of the Formula and pharmaceutically acceptable salts and prodrugs thereof, wherein A, R1, R2, R7, R8, and R9 are as defined in the specification. Such compounds are MEK inhibitors and useful in the treatment of hyperproliferative diseases, such as cancer and inflammation, in mammals. Also disclosed is a method of using such compounds in the treatment of hyperproliferative diseases in mammals, and pharmaceutical compositions containing such compounds.

    Patent expiration dates:

    • March 13, 2023
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      Drug substance
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      Drug product
  • Hydrogen sulfate salt
    Patent 9,156,795
    Issued: October 13, 2015
    Assignee(s): Array BioPharma, Inc. Astrazeneca AB

    The present invention relates to Compound 1 hydrogen sulfate salt and solvates, crystalline forms and amorphous forms thereof, and to processes for their preparation.

    Patent expiration dates:

    • December 12, 2026
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      Drug substance
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      Drug product
  • Hydrogen sulfate salt
    Patent 9,562,017
    Issued: February 7, 2017
    Assignee(s): AsrtaZeneca AB Array BioPharma Inc.

    The present invention relates to Compound 1 hydrogen sulfate salt and solvates, crystalline forms and amorphous forms thereof, and to processes for their preparation.

    Patent expiration dates:

    • December 12, 2026
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      Patent use: TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)
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      Drug substance

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:

    • April 10, 2025 - NEW CHEMICAL ENTITY
    • April 10, 2027 -

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.