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 forty-three patent family members in twenty-eight countries.

The generic ingredient in COSELA is trilaciclib dihydrochloride. One supplier is 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 has been one patent litigation case 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:	143
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	4
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

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
Wake Forest University Health Sciences	Phase 2
Merck Sharp & Dohme LLC	Phase 2
G1 Therapeutics, Inc.	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.

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
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y	Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes				Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes

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
Canada	3045465
China	106967074
China	117530948
Croatia	P20192168
Israel	303038	שימור של תגובה חיסונית במהלך משטרי כימותרפיה (Preservation of immune response during chemotherapy regimens)
South Korea	20190092478	화학요법 레지멘 동안의 면역 반응의 보존
World Intellectual Property Organization (WIPO)	2014144847

Market Dynamics and Financial Trajectory for COSELA (Trilaciclib)

Introduction

COSELA (trilaciclib) is a groundbreaking drug developed by G1 Therapeutics, primarily used in the treatment of extensive-stage small cell lung cancer. Here, we delve into the market dynamics and financial trajectory of COSELA, highlighting its performance, growth, and future prospects.

Market Position and Growth

COSELA has established itself as a significant player in the oncology market, particularly in the treatment of extensive-stage small cell lung cancer. The drug's unique benefits, such as reducing the severity of chemotherapy-induced myelosuppression, have been well-received by oncologists and patients alike.

• Revenue Growth: In 2023, COSELA generated $46.3 million in net revenue, representing a 48% growth over 2022. This robust growth is a testament to the drug's increasing adoption and market penetration[1][2][4].

• Quarterly Performance: The fourth quarter of 2023 saw a 29% increase in net COSELA revenue to $13.9 million, despite challenges from a platinum-based chemotherapy shortage. This trend continued into 2024, with the first quarter showing $14.1 million in net COSELA revenue and a 4% growth in vial volume over the prior quarter[1][2].

• Recent Highlights: In the second quarter of 2024, COSELA's net revenue grew 12% over the prior quarter to $15.8 million, with a 10% increase in vial volume. This double-digit quarter-over-quarter growth underscores the drug's continued market traction[4].

Financial Performance

G1 Therapeutics' financial health is closely tied to the performance of COSELA.

• Total Revenues: For the full year 2023, total revenues were $82.5 million, including $46.3 million from COSELA sales and $36.2 million in license revenue. This represents a significant increase from the prior year's total revenues of $51.3 million[1].

• Quarterly Financials: In the first quarter of 2024, total revenue was $14.5 million, with $14.1 million coming from COSELA sales. Operating expenses decreased compared to the first quarter of 2023, contributing to a healthier financial outlook[2].

• Cash Runway: As of the end of 2023, G1 Therapeutics had $82.2 million in cash, cash equivalents, and marketable securities. This cash runway extends into the third quarter of 2025, providing the company with sufficient funds to continue its operations and capital expenditures[1][2][4].

Clinical Trials and Future Prospects

The ongoing and future clinical trials are crucial for the continued success and potential expansion of COSELA.

• PRESERVE 2 Trial: The final analysis of the Phase 3 PRESERVE 2 trial, evaluating overall survival in metastatic triple-negative breast cancer, is expected in the third quarter of 2024. This trial holds significant potential for label expansion and broader market access[1].

• Survival Benefits: New analyses have shown that patients who received trilaciclib in clinical trials experienced improved overall survival with subsequent anticancer therapies. This robust long-term survival benefit is a strong indicator of the drug's efficacy and future growth potential[1].

Market Dynamics and Adoption

Several factors contribute to COSELA's market dynamics and adoption.

• Guideline Recommendations: The recent update by the American Society of Clinical Oncology (ASCO) recommending the use of COSELA in small cell lung cancer guidelines has further bolstered its market position. This endorsement by a prestigious medical organization highlights the drug's clinical value and is expected to drive increased adoption[3].

• Partnerships and Agreements: G1 Therapeutics has entered into significant partnerships, such as the agreement with Simcere to buy out milestones and royalties in Greater China, which has strengthened the company's balance sheet and expanded market reach[5].

Mergers and Acquisitions

The recent announcement of a definitive merger agreement with Pharmacosmos is set to impact COSELA's market dynamics significantly.

• Merger with Pharmacosmos: The transaction, expected to close in the late third quarter of 2024, is anticipated to deliver a significant premium to G1 Therapeutics' shareholders and enhance access to COSELA for cancer patients. This merger is expected to accelerate the growth of the COSELA business[4].

Operational Efficiency and Cost Management

G1 Therapeutics has been focused on improving operational efficiency and managing costs effectively.

• Operating Expenses: The company expects a 25% to 30% reduction in full-year operational expenses in 2024 compared to 2023. This reduction is part of a broader strategy to achieve profitability in the second half of 2025[4].

Conclusion

COSELA's market dynamics and financial trajectory are marked by strong revenue growth, robust clinical trial outcomes, and strategic partnerships. As the drug continues to gain traction in the oncology market, G1 Therapeutics is well-positioned for future success, particularly with the impending merger with Pharmacosmos.

Key Takeaways

• Revenue Growth: COSELA achieved $46.3 million in net revenue in 2023, with a 48% growth over 2022.
• Clinical Trials: The final analysis of the Phase 3 PRESERVE 2 trial is expected in Q3 2024, with potential for label expansion.
• Market Adoption: ASCO's guideline update recommending COSELA has boosted its market position.
• Financial Health: G1 Therapeutics has a cash runway extending into Q3 2025, with reduced operational expenses expected in 2024.
• Merger: The merger with Pharmacosmos is expected to enhance access to COSELA and deliver a premium to shareholders.

FAQs

Q: What is COSELA used for? A: COSELA (trilaciclib) is used primarily in the treatment of extensive-stage small cell lung cancer to reduce the severity of chemotherapy-induced myelosuppression.

Q: How has COSELA performed financially in recent years? A: COSELA generated $46.3 million in net revenue in 2023, representing a 48% growth over 2022. The drug continues to show strong quarter-over-quarter growth in 2024.

Q: What are the key clinical trials for COSELA? A: The Phase 3 PRESERVE 2 trial evaluating overall survival in metastatic triple-negative breast cancer is a significant ongoing trial, with the final analysis expected in Q3 2024.

Q: How does the merger with Pharmacosmos impact COSELA? A: The merger is expected to enhance access to COSELA for cancer patients, deliver a significant premium to G1 Therapeutics' shareholders, and accelerate the growth of the COSELA business.

Q: What is the current cash runway for G1 Therapeutics? A: As of the second quarter of 2024, G1 Therapeutics has a cash runway extending into the third quarter of 2025, with $60.7 million in cash, cash equivalents, and marketable securities.

Sources

1. G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights. Globenewswire.
2. G1 Therapeutics Provides First Quarter 2024 Financial Results and Operational Highlights. Stocktitan.
3. G1 Therapeutics Provides Third Quarter 2023 Financial Results and Operational Highlights. G1 Therapeutics Investor Relations.
4. G1 Therapeutics Provides Second Quarter 2024 Financial Results and Operational Highlights. Biospace.
5. G1 Therapeutics Provides First Quarter 2023 Financial Results and Operational Highlights. Stocktitan.