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Generic Cosela Availability

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 FAQs.

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.

  • Patent 10,085,992

    Patent expiration dates:

    • March 14, 2034
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      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
  • Patent 10,189,849

    Patent expiration dates:

    • October 25, 2031
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      Drug substance
  • Patent 10,189,850

    Patent expiration dates:

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

    Patent expiration dates:

    • October 25, 2031
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      Drug product
  • Patent 8,598,186

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      Drug substance
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      Drug product
  • Patent 8,598,197

    Patent expiration dates:

    • October 25, 2031
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Patent 9,487,530

    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 9,957,276

    Patent expiration dates:

    • October 25, 2031
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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:

    • 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.