THIOLA Drug Patent Profile

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Which patents cover Thiola, and when can generic versions of Thiola launch?

Thiola is a drug marketed by Mission Pharma and Mission Pharmacal and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in THIOLA is tiopronin. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tiopronin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Thiola

A generic version of THIOLA was approved as tiopronin by TEVA PHARMS USA INC on April 26^th, 2021.

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Summary for THIOLA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	1
Patent Applications:	1,141
Drug Prices:	Drug price information for THIOLA
What excipients (inactive ingredients) are in THIOLA?	THIOLA excipients list
DailyMed Link:	THIOLA at DailyMed

Drug patent expirations by year for THIOLA

Recent Clinical Trials for THIOLA

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

Sponsor	Phase
University of Washington	Phase 2
University of Florida	Phase 2
E. Sander Connolly	Phase 2

See all THIOLA clinical trials

Pharmacology for THIOLA

Drug Class	Reducing and Complexing Thiol
Mechanism of Action	Cystine Disulfide Reduction

US Patents and Regulatory Information for THIOLA

THIOLA is protected by zero US patents and one FDA Regulatory Exclusivity.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mission Pharma	THIOLA	tiopronin	TABLET;ORAL	019569-001	Aug 11, 1988	AB	RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes	11,458,104	⤷ Subscribe				⤷ Subscribe
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No	11,458,104	⤷ Subscribe				⤷ Subscribe
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

THIOLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for THIOLA

Introduction

THIOLA, also known as tiopronin, is a crucial drug in the treatment of cystinuria and other kidney stone diseases. To understand its market dynamics and financial trajectory, it is essential to delve into various aspects including market size, growth drivers, key players, and financial performance.

Market Size and Growth

The global tiopronin market, which includes THIOLA, has been experiencing significant growth in recent years. In 2022, the market size was substantial and is forecasted to grow further by 2029, driven by increasing demand for effective treatments for rare diseases like cystinuria[4].

Growth Drivers

Several factors are driving the growth of the tiopronin market:

Increasing Prevalence of Kidney Stone Diseases: The rising incidence of kidney stone diseases globally is a major driver, as tiopronin is a key treatment option.
Advancements in Healthcare: Improvements in healthcare infrastructure and access to advanced treatments are boosting the demand for tiopronin.
Regulatory Support: Favorable regulatory environments and approvals for new indications can significantly impact market growth[4].

Key Player: Travere Therapeutics

Travere Therapeutics is a significant player in the tiopronin market, particularly with its product THIOLA.

Product Sales

Travere Therapeutics reports substantial revenue from tiopronin products. For example:

In the first quarter of 2022, net product sales for tiopronin products (Thiola/Thiola EC) were $21.4 million, contributing to the company's total net product sales of $46.4 million[1].
For the full year 2021, tiopronin product sales totaled $115.1 million, which was part of the company's total net product sales of $210.8 million[2].

Quarterly Performance

In recent quarters, THIOLA has continued to contribute steadily to Travere Therapeutics' revenue. For instance, in the first quarter of 2024, Thiola and Thiola EC contributed approximately $20 million in net product sales[5].

Financial Performance

Revenue Trends

Travere Therapeutics has seen organic growth in net product sales, with a stable revenue stream from tiopronin products. Here are some key financial metrics:

Annual Growth: The company saw a 6% increase in net product sales in 2021 compared to the previous year, indicating stable demand for tiopronin[2].
Quarterly Revenue: The overall net product sales for Travere Therapeutics in the second quarter of 2024 were $52.2 million, with tiopronin products contributing a significant portion[5].

Operating Expenses

Operating expenses are a critical component of Travere Therapeutics' financial performance.

Research and Development (R&D) Expenses: R&D expenses are significant, reflecting ongoing investments in pipeline development. In Q2 2022, R&D expenses were $59.7 million, and this trend continues, supporting the overall growth of the company's product portfolio, including tiopronin[2].
Selling, General, and Administrative (SG&A) Expenses: SG&A expenses also play a crucial role. In Q2 2022, these expenses were $52.9 million, highlighting the company's efforts in marketing and distributing its products, including THIOLA[2].

Market Dynamics

Competitive Landscape

The tiopronin market is characterized by a competitive landscape with several manufacturers. Travere Therapeutics operates in a dynamic environment where competition from other manufacturers and generic drugs is a significant factor[4].

Regulatory Environment

Regulatory approvals and compliance are critical for the tiopronin market. Companies like Travere Therapeutics engage closely with regulatory bodies to ensure compliance and to seek approvals for new indications, which can significantly impact market dynamics[2].

Future Outlook

Growth Projections

The tiopronin market, including THIOLA, is projected to continue its growth trajectory from 2023 to 2029. This growth is driven by increasing demand and advancements in healthcare. The market is expected to expand significantly, making it an attractive segment for pharmaceutical companies[4].

Challenges and Opportunities

Challenges: Despite the growth potential, the market faces challenges such as competition from generic drugs and the need for continuous R&D to maintain market share.
Opportunities: The increasing prevalence of kidney stone diseases and the potential for new indications offer significant opportunities for growth and market expansion.

Financial Health of Travere Therapeutics

While THIOLA contributes significantly to Travere Therapeutics' revenue, the company's overall financial health is also important to consider.

Cash and Debt: As of recent reports, Travere Therapeutics holds more cash than debt on its balance sheet, providing a solid financial foundation to support ongoing operations and research development[5].
Profitability: However, the company is not expected to be profitable this year, indicated by its negative P/E ratio of -4.36. Additionally, the company's gross profit margins have been weak, with a gross profit margin of -76.57% for the last twelve months as of Q1 2023, which could signal challenges in managing costs or pricing pressures in the market[5].

Key Takeaways

Stable Revenue Stream: THIOLA continues to contribute steadily to Travere Therapeutics' revenue.
Market Growth: The tiopronin market is expected to grow significantly from 2023 to 2029, driven by increasing demand and healthcare advancements.
Competitive Landscape: The market is competitive, with several manufacturers and a dynamic regulatory environment.
Financial Health: While Travere Therapeutics faces challenges in profitability, it has a solid financial foundation to support ongoing operations and research.

FAQs

What is THIOLA used for?

THIOLA, or tiopronin, is primarily used in the treatment of cystinuria and other kidney stone diseases.

Who is the key player in the THIOLA market?