Prescription medicine
Trilaciclib Brand names: Cosela
Trilaciclib (Cosela) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the trilaciclib FDA label on DailyMed (effective August 31, 2025, Pharmacosmos Therapeutics Inc.); the NDA 214200 record on Drugs@FDA; every trilaciclib label on DailyMed.
Highlights of the record
FDA label of August 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCOSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).
Forms and strengths
- 300 mg/20ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- February 12, 2021 Cosela, Pharmacosmos; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 13, 2040 Cosela injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 241 through July 30, 2026
What is trilaciclib used for?
From the label: indications and usageCOSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (COSELA), Pharmacosmos Therapeutics Inc., effective August 31, 2025 (SPL set b3179c19-78f3-4bf1-b73e-7f7638522ab1), via openFDA; the full label on DailyMed
Is there a generic for trilaciclib (Cosela)?
No generic trilaciclib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Cosela injection: the compound patent runs to November 13, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the trilaciclib label say about other medicines?
The trilaciclib label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cisplatin | drug interactions | Drugs: Cisplatin; Recommendations: Closely monitor for nephrotoxicity.; Comments: Concurrent treatment with COSELA may increase the exposure and alter the net accumulation of cisplatin in the kidney, which may associate with dose-related nephrotoxicity. |
| Dalfampridine | drug interactions | Drugs: Dalfampridine; Recommendations: The potential benefits of taking COSELA concurrently with dalfampridine should be considered against the risk of seizures in these patients.; Comments: Increased dalfampridine blood levels may occur in patients who are also receiving COSELA. … |
| Dofetilide | drug interactions | Drugs: Dofetilide; Recommendations: The potential benefits of taking COSELA concurrently with dofetilide should be considered against the risk of QT interval prolongation.; Comments: Increased dofetilide blood levels may occur in patients who are also receiving COSELA. … |
| Epinephrine | warnings and precautions | One patient experienced a Grade 2 anaphylactic reaction 4 days after receiving COSELA, which resolved with epinephrine, and treatment with COSELA was continued. |
Source: FDA drug label (COSELA), Pharmacosmos Therapeutics Inc., effective August 31, 2025 (SPL set b3179c19-78f3-4bf1-b73e-7f7638522ab1), via openFDA; the full label on DailyMed
What do FAERS reports show for trilaciclib?
The FDA Adverse Event Reporting System holds 241 reports that list trilaciclib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25 are coded as a death and 78 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Trilaciclib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other