Trilaciclib dihydrochloride - Generic Drug Details

What are the generic sources for trilaciclib dihydrochloride and what is the scope of freedom to operate?

Trilaciclib dihydrochloride is the generic ingredient in one branded drug marketed by Pharmacosmos and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trilaciclib dihydrochloride has one hundred and fifty-three patent family members in twenty-eight countries.

Two suppliers are listed for this compound.

Summary for trilaciclib dihydrochloride

International Patents:	153
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	40
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for trilaciclib dihydrochloride
DailyMed Link:	trilaciclib dihydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for trilaciclib dihydrochloride

Constraining patent/regulatory exclusivity:

10,189,849

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for trilaciclib dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	PHASE3
The Second Affiliated Hospital of Shandong First Medical University	PHASE2
The First Affiliated Hospital of Xiamen University	PHASE2

See all trilaciclib dihydrochloride clinical trials

Pharmacology for trilaciclib dihydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Cyclin-dependent Kinase 4 Inhibitors Cyclin-dependent Kinase 6 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for trilaciclib dihydrochloride

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for TRILACICLIB DIHYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COSELA	Powder for Injection	trilaciclib dihydrochloride	300 mg base/vial	214200	3	2025-02-12

US Patents and Regulatory Information for trilaciclib dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	9,957,276			Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	10,085,992
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	11,717,523

International Patents for trilaciclib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2011323739
South Korea	20140003427	CDK INHIBITORS
China	107417691

Market Dynamics and Financial Trajectory for Trilaciclib Dihydrochloride

Last updated: July 30, 2025

Introduction

Trilaciclib dihydrochloride has emerged as a significant therapeutic agent within oncology treatment regimens, primarily focusing on mitigating chemotherapy-induced myelosuppression. Developed by G1 Therapeutics, this CDK4/6 inhibitor enhances patient outcomes by preserving hematopoietic function during chemotherapy. Understanding its market dynamics and financial trajectory involves analyzing clinical development stages, commercialization strategies, competitive landscape, regulatory environment, and healthcare market trends.

Pharmacological Profile and Therapeutic Indication

Trilaciclib dihydrochloride functions as a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupting cell cycle progression in rapidly dividing cells, including hematopoietic stem and progenitor cells. Its primary indication targets patients undergoing chemotherapy for extensive-stage small cell lung cancer (ES-SCLC). The agent's unique mechanism aims to reduce the incidence and severity of chemotherapy-induced myelosuppression—namely anemia, neutropenia, and thrombocytopenia—thereby improving treatment adherence and patient quality of life.

Market Dynamics

Growing Oncology Treatment Market

The global oncology market is projected to expand annually at a compound annual growth rate (CAGR) exceeding 7%, driven by increasing cancer incidence and advancements in targeted therapies. Within this landscape, supportive care medications like trilaciclib address a significant unmet need, especially in managing chemotherapy-associated toxicities.

Unmet Medical Need and Differentiation

Chemotherapy-induced myelosuppression remains a critical barrier to effective cancer treatment, leading to dose delays, reductions, and hospitalization. Existing supportive care options include granulocyte colony-stimulating factors (G-CSFs) and erythropoiesis-stimulating agents (ESAs). Trilaciclib's novel mechanism offers potential advantages, such as transient hematopoietic stem cell protection without compromising chemotherapeutic efficacy, positioning it as a differentiated therapy in supportive care.

Market Penetration and Adoption

Although regulatory approval was achieved in key markets like the U.S., uptake depends on physician acceptance, clinical evidence, and reimbursement policies. The drug's label approval for ES-SCLC suggests targeted adoption, with potential expansion to other cancers and supportive care contexts as additional research accumulates.

Competitive Landscape

The competitive environment features established supportive care treatments, including G-CSFs (e.g., Neulasta, Neupogen) and emerging agents. Trilaciclib’s unique mechanism aimed at cellular protection differentiates it, but penetration depends on clinical validation, pricing strategies, and formulary inclusion.

Pricing and Reimbursement Strategies

Pricing strategies are critical in oncology supportive care, where cost offsets from reduced hospitalizations and treatment delays influence payer decision-making. Initial pricing positioned trilaciclib at a premium, reflective of its innovation and targeted patient population. Reimbursement coverage varies across countries, affecting market access and financial sustainability.

Financial Trajectory

Revenue Generation

Since its initial approval in 2021, trilaciclib has generated revenue predominantly within the U.S. market, with limited international sales. Revenue growth hinges on uptake rates, clinical evidence supporting its use, and competitive positioning.

Investment and Development Costs

G1 Therapeutics has invested significantly in clinical trials, regulatory approvals, and commercialization. The company's financial health reflects expenditures associated with demonstrating efficacy, safety, and market entry strategies.

Market Expansion Opportunities

Potential expansion into other oncology indications, larger patient populations, or adjunctive supportive care roles could substantially alter revenue forecasts. The upcoming results from ongoing trials assessing trilaciclib's efficacy in other cancers will influence future financial trajectories.

Long-term Outlook

Projected revenue streams are optimistic if clinical benefits are validated across diverse indications and if payers reimburse broadly. Conversely, competition and market saturation could temper growth, emphasizing the importance of continuous clinical and market development.

Regulatory and Policy Influences

Regulatory milestones—such as approvals in additional jurisdictions and positive advisory committee outcomes—can accelerate market penetration. Conversely, safety concerns or regulatory setbacks could impede growth.

Reimbursement Landscape

Reimbursements, predominantly in the U.S., hinge on favorable coverage decisions by the Centers for Medicare & Medicaid Services (CMS) and private insurers. Demonstrating cost-effectiveness through pharmacoeconomic analyses remains pivotal in securing reimbursement.

Market Outlook and Strategic Implications

Future success relies on several strategic factors:

• Demonstrating efficacy and safety through ongoing and future trials.

• Developing robust relationships with oncologists and healthcare providers.

• Securing reimbursement agreements and formulary placements.

• Exploring indications beyond ES-SCLC.

Overall, trilaciclib’s market trajectory will be shaped by its ability to establish itself as the standard of supportive care in chemotherapy regimens, while extending into other cancer treatments.

Key Takeaways

• Trilaciclib dihydrochloride addresses a substantial unmet need in chemotherapy supportive care, providing a differentiated mechanism that preserves hematopoietic function.
• Market growth is supported by the expanding oncology landscape and increasing demand for supportive therapies, yet real-world adoption depends on clinical validation, cost-effectiveness, and payer coverage.
• Revenue prospects are promising in the short term within the U.S., with potential international expansion contingent upon regulatory approvals and evidence.
• Competitive advantages include its novel mode of action; however, ongoing clinical trials and health economics evaluations are critical for sustained growth.
• Long-term market success requires strategic positioning, continuous clinical research, and proactive engagement with healthcare stakeholders.

FAQs

1. What are the primary clinical benefits of trilaciclib dihydrochloride?
Trilaciclib significantly reduces the incidence and severity of chemotherapy-induced myelosuppression, allowing patients to maintain chemotherapy dose intensity and improve quality of life without compromising treatment efficacy.

2. Which patient population is most likely to benefit from trilaciclib?
Patients with extensive-stage small cell lung cancer receiving chemotherapy are the primary beneficiaries, especially those at high risk for myelosuppression. Potential expansion to other cancers is under investigation.

3. How does trilaciclib’s market penetration compare to traditional supportive care options?
While traditional supportive care drugs like G-CSFs are well-established, trilaciclib’s innovative mechanism offers a potentially superior safety profile and efficacy. Adoption depends on clinical validation, physician familiarity, and reimbursement policies.

4. What are the key regulatory milestones influencing trilaciclib’s market trajectory?
Regulatory approvals in major markets, positive supplemental labeling, and expansion of indications are crucial. The FDA’s approval in 2021 marked a significant milestone, with ongoing trials potentially bolstering future approvals.

5. What is the outlook for trilaciclib’s long-term financial performance?
If clinical benefits are confirmed across multiple indications, and reimbursement barriers are addressed, trilaciclib has the potential for sustained revenue growth. Market expansion and competitive positioning will be decisive factors.

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References

[1] G1 Therapeutics. (2022). Trilaciclib (G1T38) Summary of Product Characteristics.
[2] MarketWatch. (2023). “Global Oncology Supportive Care Market Analysis.”
[3] FDA. (2021). Approval of Trilaciclib for Small Cell Lung Cancer.
[4] Evaluate Pharma. (2022). Cancer Supportive Care Drug Market Forecast.
[5] IQVIA. (2023). Pharmaceutical Market Trends in Oncology.