Trilaciclib dihydrochloride - Generic Drug Details

What are the generic drug 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 forty-five patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for trilaciclib dihydrochloride

International Patents:	145
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Phase 2
Wake Forest University Health Sciences	Phase 2
Merck Sharp & Dohme LLC	Phase 2

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	11,717,523
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	11,040,042		Y
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	12,168,666		Y	Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	10,085,992

International Patents for trilaciclib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	102186969
Japan	2017186357
World Intellectual Property Organization (WIPO)	2014144326
Japan	6738933
Canada	2906166	TRAITEMENTS EPARGNANT HSPC POUR LA PROLIFERATION CELLULAIRE ANORMALE RB POSITIVE (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)

Market Dynamics and Financial Trajectory for Trilaciclib Dihydrochloride

Introduction to Trilaciclib Dihydrochloride

Trilaciclib dihydrochloride, marketed as COSELA, is a novel therapy developed by G1 Therapeutics. It is designed to transiently arrest cells dependent on CDK4/6 for proliferation, particularly hematopoietic stem and progenitor cells (HSPCs), in the G1 phase. This mechanism makes it a valuable asset in reducing chemotherapy-induced myelosuppression (CIM) and enhancing the efficacy of various cancer treatments.

Current Market Indications and Opportunities

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Trilaciclib was approved by the FDA in February 2021 to decrease the incidence of CIM in adult patients with ES-SCLC when administered prior to platinum-/etoposide-containing regimens or topotecan-containing regimens. This approval has been a significant milestone, with the drug being recommended by the National Comprehensive Cancer Network (NCCN) guidelines for ES-SCLC and other hematopoietic growth factors[4].

Triple Negative Breast Cancer (TNBC)

G1 Therapeutics is actively pursuing the development of trilaciclib in various TNBC treatment settings, including metastatic and early-stage TNBC. Phase 2 studies have shown potential benefits, and the company is awaiting the final analysis of the Phase 3 PRESERVE 2 trial, expected in the late second quarter of 2024. This trial evaluates overall survival in first-line metastatic TNBC, a critical area given the poor survival rates associated with TNBC[1][3].

Antibody-Drug Conjugate (ADC) Combinations

Trilaciclib is also being explored in combination with ADC treatments in TNBC and potentially other tumor types. Updated efficacy results from a Phase 2 trial of trilaciclib in combination with a TROP2 ADC are scheduled to be presented, highlighting the drug's potential to improve the efficacy and safety of ADC therapies[2].

Financial Performance and Revenue Growth

Net COSELA Revenue

In 2023, G1 Therapeutics achieved $46.3 million in net revenue from COSELA sales, representing a 48% growth over 2022. For the first quarter of 2024, the company recognized $14.1 million in net COSELA revenue, with vial volume growing by 4% over the prior quarter[2][3].

Revenue Guidance

The company has reaffirmed its 2024 net COSELA revenue guidance of $60 to $70 million, indicating a strong outlook for continued growth. The total addressable market for trilaciclib in ES-SCLC in the U.S. is estimated to exceed $700 million[1][3].

Cash Runway and Financial Management

As of the first quarter of 2024, G1 Therapeutics had a cash runway extending into the third quarter of 2025, with $65.2 million in cash, cash equivalents, and marketable securities. The company has efficiently managed its capital through non-equity dilutive financing, such as the monetization deal with Simcere, securing additional funding beyond its clinical trial readouts[2][5].

Operational Highlights and Clinical Trials

Ongoing Clinical Trials

G1 Therapeutics is focused on several ongoing clinical trials, including the pivotal Phase 3 PRESERVE 2 trial in metastatic TNBC and Phase 2 trials combining trilaciclib with ADCs. The company has completed enrollment in these trials and is awaiting key data readouts[2][5].

Post-Marketing Trials

As a condition of the FDA approval for ES-SCLC, G1 Therapeutics has initiated a post-marketing trial evaluating survival outcomes of trilaciclib in combination with topotecan in patients with ES-SCLC. The first patient was enrolled in October 2023[1].

Market Impact and Cost Savings

Budget Impact Analysis

A budget impact model developed to estimate the financial impact of prescribing trilaciclib for ES-SCLC indicated significant cost savings. The use of trilaciclib was estimated to reduce the number of myelosuppressive adverse events, leading to a cost saving of $801,254 over a 5-year period. This was achieved through reduced AE management costs and decreased use of prophylactic granulocyte colony-stimulating factors[4].

Physician Adoption

Many physicians view proactive myeloprotection as a better approach for patients and are likely to incorporate trilaciclib into their treatment regimens. This trend is supported by market research indicating a preference for trilaciclib due to its unique attributes, such as rapid onset and potent CDK4/6 inhibition[1].

Global Expansion and Partnerships

G1 Therapeutics is pursuing global expansion through ongoing partnering initiatives. The company has a strategic collaboration with Simcere, which includes participation and cost-sharing in global clinical trials, while G1 retains rights to trilaciclib outside of Greater China[5].

Key Takeaways

• Market Indications: Trilaciclib is approved for ES-SCLC and is being developed for TNBC and ADC combinations.
• Financial Growth: Net COSELA revenue has shown significant growth, with a strong revenue guidance for 2024.
• Clinical Trials: Ongoing trials include Phase 3 PRESERVE 2 in TNBC and Phase 2 ADC combination trials.
• Cost Savings: Trilaciclib reduces myelosuppressive adverse events, leading to substantial cost savings.
• Global Expansion: G1 Therapeutics is expanding globally through strategic partnerships.

Frequently Asked Questions (FAQs)

What is the current FDA approval status of trilaciclib?

Trilaciclib (COSELA) is FDA-approved to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with extensive stage small cell lung cancer (ES-SCLC)[1].

What are the key development paths for trilaciclib?

The key development paths include its use in triple negative breast cancer (TNBC) and in combination with antibody-drug conjugate (ADC) treatments[1].

How has the revenue from COSELA grown?

In 2023, net COSELA revenue grew by 48% over 2022, reaching $46.3 million. For the first quarter of 2024, revenue was $14.1 million, with a 4% increase in vial volume[2][3].

What is the estimated total addressable market for trilaciclib in ES-SCLC?

The total addressable market for trilaciclib in ES-SCLC in the U.S. is estimated to exceed $700 million[1].

What are the financial projections for G1 Therapeutics in terms of cash runway?

G1 Therapeutics' cash runway is expected to extend into the third quarter of 2025, with $65.2 million in cash, cash equivalents, and marketable securities as of the first quarter of 2024[2].

Cited Sources

1. Form 10-K for G1 Therapeutics INC filed 02/28/2024 - [PDF][1]
2. G1 Therapeutics Provides First Quarter 2024 Financial Results and Operational Highlights - [GlobeNewswire][2]
3. G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights - [GlobeNewswire][3]
4. Budget impact analysis of trilaciclib for decreasing the incidence of chemotherapy-induced myelosuppression in ES-SCLC in the US - [PDF][4]
5. G1 Therapeutics Provides First Quarter 2023 Financial Results and Recent Highlights - [StockTitan][5]

Last updated: 2024-12-17