TRODELVY Drug Profile

Summary for Tradename: TRODELVY

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for TRODELVY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRODELVY

Recent Clinical Trials for TRODELVY

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Fundación para el Progreso de la Oncología en Cantabria	Phase 2
Apices Soluciones S.L.	Phase 2
Henry Ford Health System	Phase 1

See all TRODELVY clinical trials

Recent Litigation for TRODELVY

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Highland Capital v. NexPoint Asset	2023-09-06
Highland v. NexPoint	2023-09-06
Highland Capital Management, L.P. - Adversary Proceeding	2021-01-22

See all TRODELVY litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for TRODELVY Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TRODELVY Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for TRODELVY Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Gilead Sciences, Inc.	TRODELVY	sacituzumab govitecan-hziy	For Injection	761115		2032-12-13	Patent claims search
Gilead Sciences, Inc.	TRODELVY	sacituzumab govitecan-hziy	For Injection	761115		2032-12-13	Patent claims search
Gilead Sciences, Inc.	TRODELVY	sacituzumab govitecan-hziy	For Injection	761115		2032-12-13	Patent claims search
Gilead Sciences, Inc.	TRODELVY	sacituzumab govitecan-hziy	For Injection	761115		2035-06-25	Patent claims search
Gilead Sciences, Inc.	TRODELVY	sacituzumab govitecan-hziy	For Injection	761115		2032-12-13	Patent claims search
Gilead Sciences, Inc.	TRODELVY	sacituzumab govitecan-hziy	For Injection	761115		2035-09-30	Patent claims search

TRODELVY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Trodelvy

Introduction

Trodelvy, an antibody-drug conjugate (ADC) developed by Gilead Sciences, has been making significant strides in the oncology market, particularly in the treatment of advanced breast and bladder cancers. Here, we delve into the market dynamics and financial trajectory of Trodelvy, highlighting its performance, challenges, and future prospects.

Approval and Indications

Trodelvy, also known as sacituzumab govitecan-hziy, was approved by the US FDA in April 2020 for the treatment of metastatic triple-negative breast cancer (mTNBC) and later for advanced, pretreated, hormone receptor-positive, HER2-negative breast cancer in February 2023[4][5].

Sales Performance

Trodelvy has shown impressive sales growth since its approval. In 2020, following Gilead's acquisition of Immunomedics, Trodelvy generated $49 million in sales in the United States[3].

2022 Financials

In 2022, Trodelvy's sales skyrocketed by 78.9% year-over-year, reaching $673.9 million. This significant increase was driven by strong uptake in new patient populations and expanded treatment indications[1].

Quarterly Performance

In the second quarter of 2023, Trodelvy's sales jumped by 64% to $260 million compared to the same quarter in the previous year. This growth was attributed to its approval for additional indications and increased adoption in clinical practice[5].

Market Expansion

The European Commission's approval of Trodelvy for advanced, pretreated, hormone receptor-positive, HER2-negative breast cancer in 2023 further expanded its market reach. This approval has been crucial in driving global sales and increasing patient access to the drug[5].

Clinical Trials and Development

Despite a recent setback with the failed EVOKE-01 study in previously treated metastatic non-small cell lung cancer (NSCLC), Gilead remains confident in Trodelvy's long-term potential. The company is pushing forward with the EVOKE-03 trial in the front-line NSCLC setting and has several phase 3 readouts planned, including a bladder cancer confirmatory study and an update to a triple-negative breast cancer trial[4].

Financial Impact on Gilead Sciences

Trodelvy's success has been a key driver for Gilead Sciences' oncology franchise. The drug's revenue growth has contributed significantly to Gilead's overall financial performance, particularly in offsetting declines in other product sales such as Veklury (remdesivir)[2][5].

Revenue Contribution

In 2022, Gilead's total revenue was $27.3 billion, with oncology sales playing a crucial role. While the company's overall revenue was flat compared to 2021, the growth in oncology sales, driven in part by Trodelvy, was a positive factor[2].

Challenges and Future Prospects

Manufacturing and Distribution

Gilead is working to expand the footprint of its authorized treatment centers (ATCs) to meet patient demand more effectively. Currently, the mismatch between where patients are treated and where ATCs operate has been a barrier to growth. However, efforts to expand these centers are underway to improve accessibility and drive further growth[4].

Competitive Landscape

The oncology market is highly competitive, with several other ADCs and cancer therapies vying for market share. However, Trodelvy's strong clinical data and expanding indications position it favorably in this competitive landscape.

Long-Term Strategy

Gilead aims to derive a significant portion of its revenue from the oncology sector by 2030. Currently, oncology contributes around 11% of Gilead's revenue, but the company is targeting a third of its revenue to come from this sector in the future. Trodelvy is expected to play a pivotal role in achieving this goal[4].

Key Takeaways

• Strong Sales Growth: Trodelvy has seen significant sales growth since its approval, with a 78.9% year-over-year increase in 2022.
• Market Expansion: Approvals in new indications and regions have expanded Trodelvy's market reach.
• Clinical Trials: Despite setbacks, Gilead remains confident in Trodelvy's long-term potential and is advancing several phase 3 trials.
• Financial Impact: Trodelvy is a key driver for Gilead's oncology franchise and contributes substantially to the company's revenue.
• Future Prospects: Gilead is working to expand treatment centers and aims for oncology to contribute a third of its revenue by 2030.

FAQs

What is Trodelvy used for?

Trodelvy is an antibody-drug conjugate used for the treatment of advanced breast and bladder cancers, including metastatic triple-negative breast cancer (mTNBC) and hormone receptor-positive, HER2-negative breast cancer.

How has Trodelvy performed in terms of sales?

In 2022, Trodelvy generated $673.9 million in sales, a 78.9% increase from the previous year. In the second quarter of 2023, sales jumped by 64% to $260 million.

What challenges is Gilead facing with Trodelvy?

Gilead faces challenges related to the expansion of authorized treatment centers to meet patient demand and the competitive landscape of the oncology market.

What are Gilead's long-term plans for its oncology franchise?

Gilead aims to derive a third of its revenue from the oncology sector by 2030, with Trodelvy expected to play a significant role in achieving this goal.

How has the failed EVOKE-01 study impacted Gilead's confidence in Trodelvy?

Despite the failed EVOKE-01 study, Gilead maintains a high level of confidence in Trodelvy's long-term potential and is proceeding with other clinical trials, including the EVOKE-03 trial in front-line NSCLC.

Sources

1. Trends in the Development of Antibody-Drug Conjugates for Cancer Therapy - MDPI
2. Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results - Gilead Sciences
3. Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results - Gilead Sciences
4. Gilead's at 'just the beginning' of cell therapy movement: exec - FiercePharma
5. Gilead Sciences' Trodelvy Gains Ground With 64 Percent Revenue Jump in Q2 - Precision Medicine Online