Generic Cosela Availability

Last updated on Apr 10, 2025.

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

COSELA (trilaciclib dihydrochloride - powder;intravenous)

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

Is there a generic version of Cosela available?

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.

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
Inventor(s): Strum Jay Copeland & Bisi John Emerson & Roberts Patrick Joseph & Tavares Francis Xavier
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
Inventor(s): Tavares Francis X. & Strum Jay C.
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
Inventor(s): Tavares Francis X. & Strum Jay C.
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
CDK inhibitors
Patent 10,927,120
Issued: February 23, 2021
Inventor(s): Tavares Francis X. & Strum Jay Copeland
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 product
Transient protection of normal cells during chemotherapy
Patent 10,966,984
Issued: April 6, 2021
Inventor(s): Strum Jay Copeland & Bisi John Emerson & Roberts Patrick Joseph & Tavares Francis Xavier
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
Transient protection of normal cells during chemotherapy
Patent 11,040,042
Issued: June 22, 2021
Inventor(s): Strum Jay Copeland & Bisi John Emerson & Roberts Patrick Joseph & Tavares Francis Xavier
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:
- October 25, 2031
  ✓
  Drug product
Preservation of immune response during chemotherapy regimens
Patent 11,529,352
Issued: December 20, 2022
Inventor(s): Sorrentino; Jessica A. et al.
Assignee(s): G1 Therapeutics, Inc. (Research Triangle Park, NC)
The addition of a selective, fast-acting, short half-life CDK 4/6 inhibitor in a very specific dosage regimen to the combination of chemotherapy with a checkpoint inhibitor provides superior results in the treatment of a tumor or cancer. The unexpected discovery is that the short pulsatile specifically-timed administration of a selective, fast-acting, short half-life CDK 4/6 inhibitor during administration of the chemotherapy portion of the triple combination therapy has a profound effect on the immune cells in the cancer microenvironment.
Patent expiration dates:
- July 23, 2039
  ✓
  Patent use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A PLATINUM/ETOPOSIDE-CONTAINING REGIMEN THAT INCLUDES AN IMMUNE CHECKPOINT INHIBITOR FOR EXTENSIVE-STAGE SMALL CELL CANCER
Transient protection of normal cells during chemotherapy
Patent 11,717,523
Issued: August 8, 2023
Inventor(s): Strum; Jay Copeland et al.
Assignee(s): G1 Therapeutics, Inc. (Research Triangle Park, NC)
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 FOR REDUCING 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 FOR REDUCING THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A TOPOTECAN-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER
Morphic forms of trilaciclib and methods of manufacture thereof
Patent 12,168,666
Issued: December 17, 2024
Inventor(s): Schneider; Stephen et al.
Assignee(s): G1 Therapeutics, Inc. (Research Triangle Park, NC)
An advantageous isolated morphic form of trilaciclib which is 2′-((5-(4-methylpiperazin-1-yl)pyridin-2-yl)amino)-7′,8′-dihydro-6′H-spiro[cyclohexane-1,9′-pyrazino[1′,2′:1,5]pyrrolo[2,3-d]pyrimidin]-6′-one, for example in the form of a di-hydrochloride salt or a dihydrochloride, dihydrate.
Patent expiration dates:
- November 13, 2040
  ✓
  Drug substance
  ✓
  Drug product
CDK inhibitors
Patent 8,598,186
Issued: December 3, 2013
Inventor(s): Tavares Francis X. & Strum Jay C.
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
Inventor(s): Tavares Francis X. & Strum Jay C.
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
Inventor(s): Strum Jay Copeland & Bisi John Emerson & Roberts Patrick Joseph & Tavares Francis Xavier
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
Inventor(s): Tavares Francis X. & Strum Jay C.
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

More about Cosela (trilaciclib)

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Chemotherapy Toxicity

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

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill medicine is Cosela 300 mg lyophilized powder for injection — Cosela 300 mg lyophilized powder for injection