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Generic Cosela Availability

Last updated on Jun 8, 2022.

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

COSELA (trilaciclib dihydrochloride - powder;intravenous)

  • Manufacturer: G1 THERAP
    Approval date: February 12, 2021
    Strength(s): EQ 300MG BASE/VIAL [RLD]

Has a generic version of Cosela been approved?

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

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

  • Transient protection of normal cells during chemotherapy
    Patent 10,085,992
    Issued: October 2, 2018
    Assignee(s): G1 Therapeutics, Inc.

    This invention is in the area of improved compounds, compositions and methods of transiently protecting healthy cells, and in particular hematopoietic stem and progenitor cells (HSPC) as well as renal cells, from damage associated with DNA damaging chemotherapeutic agents. In one aspect, improved protection of healthy cells is disclosed using disclosed compounds that act as highly selective and short, transiently-acting cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors when administered to subjects undergoing DNA damaging chemotherapeutic regimens for the treatment of proliferative disorders.

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Patent use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A CARBOPLATIN AND ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER
  • CDK inhibitors
    Patent 10,189,849
    Issued: January 29, 2019
    Assignee(s): G1 Therapeutics, Inc.

    Compounds of formulae I, II or III, and pharmaceutically acceptable salts thereof, are useful as CDK inhibitors.

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      Drug substance
  • CDK inhibitors
    Patent 10,189,850
    Issued: January 29, 2019
    Assignee(s): G1 Therapeutics, Inc.

    Compounds of formulae I, II or III, and pharmaceutically acceptable salts thereof, are useful as CDK inhibitors.

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      Drug product
  • Patent 10,927,120

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      Drug product
  • Patent 10,966,984

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Patent use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A PLATINUM/ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER
    • March 14, 2034
      ✓ 
      Patent use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A TOPOTECAN-CONTAINING REGIMEN FOR EXTENSIVE- STAGE SMALL CELL LUNG CANCER
  • Patent 11,040,042

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Drug product
  • CDK inhibitors
    Patent 8,598,186
    Issued: December 3, 2013
    Assignee(s): G1 Therapeutics, Inc.

    Compounds of formulae I, II or III, and pharmaceutically acceptable salts thereof, are useful as CDK inhibitors.

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • CDK inhibitors
    Patent 8,598,197
    Issued: December 3, 2013
    Assignee(s): G1 Therapeutics, Inc.

    Compounds of formulae I, II or III, and pharmaceutically acceptable salts thereof, are useful as CDK inhibitors.

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Transient protection of normal cells during chemotherapy
    Patent 9,487,530
    Issued: November 8, 2016
    Assignee(s): G1 Therapeutics, Inc.

    This invention is in the area of improved compounds, compositions and methods of transiently protecting healthy cells, and in particular hematopoietic stem and progenitor cells (HSPC) as well as renal cells, from damage associated with DNA damaging chemotherapeutic agents. In one aspect, improved protection of healthy cells is disclosed using disclosed compounds that act as highly selective and short, transiently-acting cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors when administered to subjects undergoing DNA damaging chemotherapeutic regimens for the treatment of proliferative disorders.

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Patent use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A PLATINUM/ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER
    • March 14, 2034
      ✓ 
      Patent use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A TOPOTECAN-CONTAINING REGIMEN FOR EXTENSIVE- STAGE SMALL CELL LUNG CANCER
  • CDK inhibitors
    Patent 9,957,276
    Issued: May 1, 2018
    Assignee(s): GI Therapeutics, Inc.

    Compounds of formulae I, II or III, and pharmaceutically acceptable salts thereof, are useful as CDK inhibitors.

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      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:

    • February 12, 2026 - NEW CHEMICAL ENTITY

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.

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