TOLSURA Drug Patent Profile

When do Tolsura patents expire, and what generic alternatives are available?

Tolsura is a drug marketed by Mayne Pharma and is included in one NDA. There are five patents protecting this drug.

This drug has eighteen patent family members in ten countries.

The generic ingredient in TOLSURA is itraconazole. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tolsura

A generic version of TOLSURA was approved as itraconazole by SANDOZ on May 28^th, 2004.

Summary for TOLSURA

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	1
Patent Applications:	3,851
Drug Prices:	Drug price information for TOLSURA
What excipients (inactive ingredients) are in TOLSURA?	TOLSURA excipients list
DailyMed Link:	TOLSURA at DailyMed

See drug prices for TOLSURA

Recent Clinical Trials for TOLSURA

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

Sponsor	Phase
George R Thompson	Phase 2
Mayne Pharma International Pty Ltd	Phase 2

See all TOLSURA clinical trials

Pharmacology for TOLSURA

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for TOLSURA

TOLSURA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y

Expired US Patents for TOLSURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018

EU/EMA Drug Approvals for TOLSURA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Avimedical B.V.	Fungitraxx	itraconazole	EMEA/V/C/002722 For the treatment of aspergillosis and candidiasis in companion birds,	Authorised	no	no	no	2014-03-12

International Patents for TOLSURA

See the table below for patents covering TOLSURA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2331801
China	109674795	伊曲康唑组合物和剂型及其使用方法 (Itraconazole compositions and dosage forms, and methods of using the same)
Japan	2015531749	イトラコナゾール組成物及び投与剤形、並びにその使用方法
Japan	2012236837	IMPROVED PHARMACEUTICAL COMPOSITION FOR POORLY SOLUBLE DRUG
Spain	2398643
World Intellectual Property Organization (WIPO)	2013192566

Market Dynamics and Financial Trajectory for TOLSURA (SUBA®-itraconazole)

Introduction

TOLSURA (SUBA®-itraconazole) is a novel formulation of itraconazole, developed by Mayne Pharma Group Limited, designed to treat systemic fungal infections. This article delves into the market dynamics and financial trajectory of TOLSURA since its launch.

FDA Approval and Launch

TOLSURA received FDA approval in December 2018 and was launched in the United States in January 2019. This approval marked a significant milestone for Mayne Pharma, as it was the first New Drug Application (NDA) approved since the company listed on the ASX in 2007[3][4].

Market Need and Target Population

TOLSURA is indicated for the treatment of serious fungal infections, including blastomycosis, histoplasmosis, and aspergillosis, particularly in immunocompromised patients such as those with cancer, transplants, HIV/AIDS, or chronic rheumatic disorders. These infections are associated with high mortality rates and long-term health issues, creating a clear unmet clinical need[1][4].

Competitive Landscape

The US anti-fungal triazole market is valued at approximately $600 million, with an addressable market for TOLSURA estimated at $200 million. TOLSURA differentiates itself through its proprietary SUBA technology, which enhances the bioavailability of itraconazole, reducing variability and improving patient compliance compared to conventional oral itraconazole capsules[4].

Clinical Advantages

Clinical trials have shown that TOLSURA offers several advantages over conventional itraconazole. It demonstrates less patient variability, with 100% of TOLSURA patients achieving therapeutic levels of itraconazole by Day 42, compared to only 90% of patients on conventional itraconazole. Additionally, TOLSURA is associated with 50% fewer gastrointestinal events and a low rate of abnormal liver function tests (LFTs)[5].

Commercialization Strategy

Mayne Pharma has established a specialized field sales team focused on promoting TOLSURA to infectious disease physicians and pulmonologists, particularly in hospital settings. This institutional sales team is crucial for highlighting the benefits of TOLSURA to key healthcare providers[1][3].

Financial Performance

Initial Growth and Challenges

In the initial period following its launch, TOLSURA prescriptions grew consistently. However, the COVID-19 pandemic significantly impacted sales, with a decline in patient visits to physicians and reduced capacity at physician offices. This led to a drop in TOLSURA prescriptions during the first half of FY20[2].

Revenue and EBITDA Impact

The decline in TOLSURA prescriptions, along with broader challenges in the US generic market, affected Mayne Pharma's financial performance. The company reported a revenue decline of 13% in FY20 compared to the previous year, with EBITDA down by 28%. The Specialty Brands Division, which includes TOLSURA, saw sales decrease by 14% and gross profit by 18% due to reduced patient visits and unfavorable changes in managed care coverage[2].

Cost Optimization and Restructuring

In response to these challenges, Mayne Pharma implemented significant cost reductions, realizing over A$30 million in spend reductions. The company also restructured its dermatology sales team, which is expected to deliver annualized operating expense savings of US$12 million[2].

Patent Protection and Market Exclusivity

TOLSURA is protected by four granted patents from the United States Patent and Trademark Office, with expiry dates ranging from 2023 to 2033. This patent protection provides Mayne Pharma with a competitive edge and market exclusivity for the formulation[4].

Future Outlook

Despite the current challenges, Mayne Pharma remains optimistic about the long-term potential of TOLSURA. The company is focused on optimizing its cost base and expanding its commercial infrastructure to support the growth of its specialty brands, including TOLSURA. The addressable market and the clinical advantages of TOLSURA position it for potential growth once market dynamics stabilize[1][3][4].

Key Takeaways

• FDA Approval and Launch: TOLSURA was approved by the FDA in December 2018 and launched in January 2019.
• Market Need: TOLSURA addresses serious fungal infections in immunocompromised patients.
• Clinical Advantages: Enhanced bioavailability, reduced variability, and improved patient compliance.
• Commercialization: Specialized sales team targeting infectious disease specialists.
• Financial Performance: Initial growth impacted by COVID-19, with subsequent cost optimization measures.
• Patent Protection: Protected by four patents with expiry dates from 2023 to 2033.
• Future Outlook: Potential for growth with optimized cost base and expanded commercial infrastructure.

FAQs

What is TOLSURA used for?

TOLSURA is used for the treatment of systemic fungal infections, including blastomycosis, histoplasmosis, and aspergillosis, particularly in immunocompromised patients.

When was TOLSURA approved by the FDA?

TOLSURA was approved by the FDA in December 2018.

What is the proprietary technology behind TOLSURA?

TOLSURA incorporates Mayne Pharma’s proprietary SUBA technology, which enhances the bioavailability of itraconazole.

How has the COVID-19 pandemic affected TOLSURA sales?

The COVID-19 pandemic led to a decline in TOLSURA prescriptions due to reduced patient visits to physicians and lower capacity at physician offices.

What are the patent protection details for TOLSURA?

TOLSURA is protected by four granted patents from the United States Patent and Trademark Office, with expiry dates ranging from 2023 to 2033.

Sources

1. Biospace: TOLSURA (TM) (SUBA®-itraconazole) Antifungal Capsule Now Available in the United States.
2. ASX Announcement: 2020 Annual Report - For personal use only.
3. ASX Announcement: ASX Announcement - For personal use only.
4. Biospace: Mayne Pharma receives FDA approval of Tolsura™ (SUBA - itraconazole) capsules for the treatment of certain fungal infections.
5. TOLSURA Website: About Tolsura.