COSELA Drug Patent Profile

When do Cosela patents expire, and when can generic versions of Cosela launch?

Cosela is a drug marketed by Pharmacosmos and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-three patent family members in twenty-eight countries.

The generic ingredient in COSELA is trilaciclib dihydrochloride. Two suppliers are listed for this compound. Additional details are available on the trilaciclib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cosela

Cosela was eligible for patent challenges on February 12, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 25, 2031. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for COSELA

International Patents:	153
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	5
Drug Prices:	Drug price information for COSELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COSELA
What excipients (inactive ingredients) are in COSELA?	COSELA excipients list
DailyMed Link:	COSELA at DailyMed

See drug prices for COSELA

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

Constraining patent/regulatory exclusivity:

10,189,849

NDA:

214200

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 COSELA

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

Sponsor	Phase
Sun Yat-sen University	PHASE2
Wake Forest University Health Sciences	Phase 2
Merck Sharp & Dohme LLC	Phase 2

See all COSELA clinical trials

Pharmacology for COSELA

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

Paragraph IV (Patent) Challenges for COSELA

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 COSELA

COSELA is protected by sixteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,189,849.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,487,530
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	10,966,984
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	11,529,352
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	10,927,120		Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	12,168,666		Y	Y

International Patents for COSELA

When does loss-of-exclusivity occur for COSELA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COSELA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011323739
South Korea	20140003427	CDK INHIBITORS
China	107417691
China	104045654
Hong Kong	1222766	高效的抗贅生劑和抗增生劑 (HIGHLY ACTIVE ANTI-NEOPLASTIC AND ANTI-PROLIFERATIVE AGENTS)

Market Dynamics and Financial Trajectory for COSELA (Trilaciclib)

Last updated: November 19, 2025

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Introduction

COSELA (trilaciclib) emerges as a pioneering small-molecule CDK4/6 inhibitor designed to protect hematopoietic stem and progenitor cells during chemotherapy. Approved by the FDA in February 2021 for adult patients with extensive-stage small cell lung cancer (ES-SCLC), COSELA’s potential extends beyond its initial indication into broader oncology and supportive care markets. Analyzing current market dynamics and projecting COSELA's financial trajectory requires understanding its clinical positioning, competitive landscape, regulatory environment, and evolving healthcare needs.

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Market Background and Clinical Positioning

COSELA’s unique mechanism involves transiently arresting hematopoietic stem and progenitor cells (HSPCs) in the G1 phase of the cell cycle, thereby reducing chemotherapy-induced myelosuppression. Its approval follows compelling clinical data demonstrating reductions in severe neutropenia, anemia, and fatigue in patients undergoing chemotherapy. The drug addresses a significant unmet need in chemotherapy support, where myelosuppression often necessitates dose reductions, treatment delays, or supportive interventions like G-CSF and blood transfusions.

The initial indication covers ES-SCLC patients receiving topotecan or carboplatin plus etoposide, representing a sizeable segment of the oncology support market. The scope for expansion into other tumor types and combination regimens, along with indications for broader supportive care, forms a critical aspect of COSELA's market outlook.

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Market Dynamics

1. Competitive Landscape

Currently, the supportive care landscape for chemotherapy-induced myelosuppression predominantly relies on growth factors (e.g., G-CSF), blood transfusions, and erythropoietin-stimulating agents. COSELA positions itself as a novel prophylactic agent that may reduce the need for these interventions, offering the following competitive advantages:

• Efficacy in Mitigating Myelosuppression: Clinical trials suggest COSELA effectively reduces severe neutropenia, supporting dose intensity.
• Improved Patient Quality of Life: By decreasing fatigue, hospitalizations, and transfusions, it enhances patient well-being.
• Potential for Cost Savings: Reducing supportive care interventions could lower overall treatment costs, appealing to payers.

However, competition persists from existing supportive care drugs, generic formulations, and upcoming biologics. Long-term clinical efficacy, safety profiles, and reimbursement policies will influence market share.

2. Regulatory Environment

While FDA approval grants a considerable advantage, subsequent approvals or label expansions depend on ongoing trials and real-world data. The EMA and other regulatory agencies’ decisions may influence global deployment, especially in Europe and Asia. The recent focus on personalized medicine and supportive care regulation supports a favorable environment for COSELA’s adoption.

3. Reimbursement & Pricing

Reimbursement policies significantly impact market penetration. As an innovative supportive agent, COSELA’s pricing strategy aims to balance profitability with payer acceptance. Evidence demonstrating reduced hospitalization and supportive care costs may promote favorable reimbursement decisions.

Commercial payers may initially be cautious, prioritizing safety and cost-effectiveness data. Payer engagement followed by health technology assessments (HTAs) will shape market access and pricing trajectories.

4. Market Penetration Strategy

Oncology and supportive care specialists’ adoption, coupled with evidence dissemination through key opinion leaders (KOLs) and clinical guidelines, is crucial. Education about its mechanism and clinical benefits will drive uptake.

Additionally, expanding into other oncology indications with high myelosuppression risk—such as breast, colorectal, or hematological cancers—will diversify revenue streams.

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Financial Trajectory

1. Revenue Forecasts

Given COSELA’s current initial indication, early revenues are likely modest. However, the following factors will influence growth:

• Market Penetration Rate: Adoption rates hinge on clinical evidence, physician acceptance, and payor coverage.
• Indication Expansion: Launch in additional tumor types and supportive care indications could exponentially increase revenues.
• International Expansion: Gaining approvals outside the US, especially in Europe and Asia, will significantly augment revenue streams.

In 2022, analyst estimates suggested initial sales in the low hundreds of millions, with projections reaching $1 billion annually within 5-7 years if expansion plans succeed (source: market research reports).

2. Cost Considerations

Development, commercialization, and ongoing research incur significant expenses. However, since trilaciclib's core manufacturing process is established, gross margins are expected to improve with scale. Intellectual property protections, including patents and data exclusivity, further safeguard revenue streams.

3. Investment & Partnerships

Strategic partnerships with global pharma companies—such as leading oncology drug manufacturers—could accelerate market access. Co-marketing arrangements and licensing deals are typical for expanding reach.

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Future Outlook and Risks

Opportunities include:

• Demonstrating superiority over existing supportive care standards.
• Expanding to earlier lines of therapy or maintenance settings.
• Combining with emerging targeted therapies and immunotherapies.

Risks involve:

• Clinical uncertainty if real-world data diverge from trials.
• Competitive advances in supportive care agents.
• Regulatory changes and reimbursement challenges.
• Pricing pressures and payer resistance.

The evolving landscape underscores the importance of continued investment in clinical research and strategic commercialization approaches.

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Key Takeaways

• Market Position: COSELA is positioned as an innovative supportive care agent with potential for significant market share in oncology, contingent on further clinical validation and regulatory approvals.
• Revenue Trajectory: Immediate revenue is modest; substantial growth depends on indication expansion, geographic penetration, and payer acceptance.
• Competitive Dynamics: Its success relies on differentiating from existing supportive care options through demonstrable clinical and economic benefits.
• Regulatory & Reimbursement Climate: Favorable, but requiring ongoing alignment with healthcare policies, HTAs, and payer economics.
• Strategic Focus: Expanding indications, forging partnerships, and emphasizing value-based healthcare will optimize COSELA’s financial trajectory.

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FAQs

1. What is COSELA, and how does it work?
COSELA (trilaciclib) is a CDK4/6 inhibitor designed to transiently arrest hematopoietic stem cells, protecting them from chemotherapy-induced damage. This reduces myelosuppression, lowering risks of neutropenia and anemia.

2. What are the primary current indications for COSELA?
It is FDA-approved for adults with extensive-stage small cell lung cancer receiving chemotherapy, specifically in combination with topotecan or carboplatin plus etoposide.

3. How does COSELA compare to standard supportive care agents?
Unlike growth factors, COSELA offers a protective mechanism by shielding stem cells before chemotherapy, potentially reducing reliance on G-CSF and transfusions, and improving patient quality of life.

4. What factors influence COSELA’s future market growth?
Key factors include clinical validation, regulatory approvals in additional indications, payer reimbursement, competition from existing supportive therapies, and global expansion efforts.

5. What challenges could impede COSELA’s revenue growth?
Potential hurdles include clinical trial failures, slow clinician adoption, restrictive reimbursement policies, and competitive innovations in supportive care.

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References

[1] FDA Approval Announcement. U.S. Food and Drug Administration, 2021.
[2] Market research reports on oncology supportive care market, 2022-2023.
[3] Clinical trial data published in Journal of Clinical Oncology, 2021.
[4] Industry analyst projections on trilaciclib’s market potential, 2022.