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TURALIO Drug Patent Profile

Which patents cover Turalio, and what generic alternatives are available?

Turalio is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and thirty-six patent family members in forty-one countries.

The generic ingredient in TURALIO is pexidartinib hydrochloride. One supplier is listed for this compound. Additional details are available on the pexidartinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Turalio

Turalio was eligible for patent challenges on August 2, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 24, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TURALIO

International Patents:	136
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	1
Patent Applications:	226
Drug Prices:	Drug price information for TURALIO
What excipients (inactive ingredients) are in TURALIO?	TURALIO excipients list
DailyMed Link:	TURALIO at DailyMed

See drug prices for TURALIO

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

Constraining patent/regulatory exclusivity:

10,435,404

NDA:

211810

Dosage:

CAPSULE;ORAL

^*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 TURALIO

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2

See all TURALIO clinical trials

Pharmacology for TURALIO

Drug Class	Kinase Inhibitor
Mechanism of Action	Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 3A Inducers Kinase Inhibitors Tyrosine Kinase Inhibitors UGT1A1 Inhibitors

US Patents and Regulatory Information for TURALIO

TURALIO is protected by twelve US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,435,404.

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
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	10,189,833
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	10,961,240
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	7,893,075			Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	7,893,075			Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	10,961,240
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	9,169,250			Y

International Patents for TURALIO

When does loss-of-exclusivity occur for TURALIO?

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

Australia

Brazil

Canada

China

European Patent Office

Japan

South Korea

Taiwan

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 TURALIO around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	577011	COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR
Colombia	2017011534	Formas sólidas de quinasas que modulan un compuesto
Canada	2867918	COMPOSES ET PROCEDES POUR UNE MODULATION DE LA KINASE, ET INDICATIONS CORRESPONDANTES (COMPOUNDS AND METHODS FOR KINASE MODULATION, AND INDICATIONS THEREFOR)
China	107548394
World Intellectual Property Organization (WIPO)	2008064265
Israel	255305
Mexico	2017013975

TURALIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TURALIO

Introduction

TURALIO (pexidartinib) is a groundbreaking drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations. Here, we delve into the market dynamics and financial trajectory of TURALIO, highlighting its clinical success, market performance, and financial impact.

Clinical Success and Approval

TURALIO was approved based on the results of a multi-center international clinical trial, known as the ENLIVEN phase 3 trial. This trial demonstrated a statistically significant improvement in the overall response rate (ORR) for patients treated with TURALIO compared to those receiving a placebo. The ORR was 38%, with a complete response rate of 15% and a partial response rate of 23% after 25 weeks of treatment[1][4].

Market Approval and Expansion

The FDA approval of TURALIO marked a significant milestone as it is the first and only FDA-approved therapy for TGCT. This approval not only opened up a new treatment option for patients but also established TURALIO as a leader in this niche market. The drug has since received additional approvals, including a new dosing regimen and the inclusion of long-term efficacy data in its label, further solidifying its market position[4].

Market Performance

TURALIO's market performance has been robust, particularly given its status as a rare disease treatment. The drug has shown strong uptake in the U.S. and other markets where it has been approved. For instance, the inclusion of long-term efficacy data has enhanced its appeal to both patients and healthcare providers, contributing to its market share.

Patient Response and Long-Term Efficacy

The open-label extension part of the ENLIVEN trial provided compelling long-term efficacy data, with an ORR of 61% in patients originally randomized to the TURALIO arm. The median duration of response was not reached, indicating sustained efficacy over a prolonged period (range: 4.6+, 63.4+ months)[4].

Financial Trajectory

The financial performance of TURALIO is closely tied to its market success and the broader financial health of its manufacturer, Daiichi Sankyo.

Revenue Growth

TURALIO has contributed significantly to Daiichi Sankyo's revenue growth. While specific revenue figures for TURALIO alone are not always detailed in financial reports, the overall oncology business segment of Daiichi Sankyo, which includes TURALIO, has shown substantial growth. For example, the company's oncology business has seen significant increases in revenue, partly driven by the success of its oncology portfolio, including TURALIO[3].

Cost and Financial Support

To enhance patient access, Daiichi Sankyo has implemented financial support programs for TURALIO. The $0 TURALIO Copay Program allows eligible commercially insured patients to pay as little as $0 per prescription, with a maximum benefit of $25,000 per calendar year. Such programs help in increasing patient adherence and market penetration[5].

Regulatory Incentives

TURALIO's approval also came with the Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. This designation can include tax credits, grants, and a period of marketing exclusivity, all of which can positively impact the financial trajectory of the drug[1].

Competitive Landscape

In the rare disease space, particularly for TGCT, TURALIO holds a unique position as the first and only FDA-approved therapy. This lack of direct competition has allowed TURALIO to dominate the market for this specific indication. However, the broader oncology market is highly competitive, and TURALIO's success is also influenced by the overall performance of Daiichi Sankyo's oncology portfolio.

Financial Impact on Daiichi Sankyo

The success of TURALIO has contributed to the overall financial health of Daiichi Sankyo. The company has seen significant increases in revenue and profit, partly due to the strong performance of its oncology business. For instance, in the FY2023 Q1 financial results, Daiichi Sankyo reported a substantial increase in revenue and core operating profit, with the oncology business playing a crucial role in this growth[2][3].

R&D and SG&A Expenses

While TURALIO's success has driven revenue, it has also led to increased research and development (R&D) and selling, general, and administrative (SG&A) expenses. These expenses are necessary for maintaining market share and continuing to develop new treatments. For example, Daiichi Sankyo's R&D expenses have increased, reflecting the company's commitment to ongoing research and development in the oncology sector[2][3].

Future Projections

Looking ahead, TURALIO is expected to continue its strong market performance. The inclusion of long-term efficacy data and the new dosing regimen are likely to enhance patient and physician confidence in the drug. Additionally, Daiichi Sankyo's financial forecasts indicate continued growth in the oncology business segment, with TURALIO playing a key role in this growth.

Market Share and Expansion

TURALIO is expected to maintain its market share in the treatment of TGCT and potentially expand into other indications. The drug's success in HER2-negative and HER2-low breast cancer, although not its primary indication, could open up new market opportunities.

Key Takeaways

• Clinical Success: TURALIO has demonstrated significant clinical efficacy in treating TGCT, with a high ORR and sustained response rates.
• Market Approval: It is the first and only FDA-approved therapy for TGCT, giving it a unique market position.
• Financial Performance: TURALIO has contributed to the revenue growth and financial health of Daiichi Sankyo.
• Regulatory Incentives: The Orphan Drug designation provides additional financial benefits.
• Competitive Landscape: TURALIO dominates the market for TGCT treatment with no direct competition.
• Future Projections: Expected to continue strong market performance and potentially expand into new indications.

FAQs

What is TURALIO used for?

TURALIO (pexidartinib) is used for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

What were the key findings of the ENLIVEN trial?

The ENLIVEN trial demonstrated a statistically significant improvement in the overall response rate (ORR) for patients treated with TURALIO, with an ORR of 38% compared to no responses in the placebo group.

What financial support programs are available for TURALIO?

Eligible commercially insured patients may pay as little as $0 per prescription through the $0 TURALIO Copay Program, with a maximum benefit of $25,000 per calendar year.

How has TURALIO impacted Daiichi Sankyo's financial performance?

TURALIO has contributed to significant revenue growth and increased profit for Daiichi Sankyo, particularly within the oncology business segment.

What are the future projections for TURALIO?

TURALIO is expected to maintain its market share and potentially expand into new indications, contributing to continued growth in Daiichi Sankyo's oncology business.

Sources

1. FDA Approves First Therapy for Rare Joint Tumor. FDA.
2. FY2023 Q1 Financial Results Presentation. Daiichi Sankyo.
3. FY2023 Q2 Financial Results Presentation. Daiichi Sankyo.
4. TURALIO New Dosing Regimen Approved in the U.S. for Certain Patients with Tenosynovial Giant Cell Tumor. Daiichi Sankyo.
5. Cost & Financial Support | TURALIO® (pexidartinib) | HCP. TURALIO HCP.