Tiopronin - Generic Drug Details

What are the generic sources for tiopronin and what is the scope of freedom to operate?

Tiopronin is the generic ingredient in three branded drugs marketed by Mission Pharmacal, Amneal, Endo Operations, Teva Pharms Inc, Torrent, Mission Pharma, and Teva Pharms Usa Inc, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for tiopronin. Seven suppliers are listed for this compound.

Summary for tiopronin

US Patents:	1
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	5
Patent Applications:	2,494
What excipients (inactive ingredients) are in tiopronin?	tiopronin excipients list
DailyMed Link:	tiopronin at DailyMed

Recent Clinical Trials for tiopronin

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

Sponsor	Phase
NYU Langone Health	Phase 2
New York University School of Medicine	Phase 2
Revive Therapeutics, Ltd.	Phase 2

See all tiopronin clinical trials

Pharmacology for tiopronin

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

Anatomical Therapeutic Chemical (ATC) Classes for tiopronin

G04BX	Other urologicals
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for TIOPRONIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THIOLA EC	Delayed-release Tablets	tiopronin	300 mg	211843	1	2022-10-11

US Patents and Regulatory Information for tiopronin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	TIOPRONIN	tiopronin	TABLET, DELAYED RELEASE;ORAL	217219-001	Feb 24, 2023	AB	RX	No	No
Endo Operations	TIOPRONIN	tiopronin	TABLET;ORAL	216198-001	Jun 2, 2022		DISCN	No	No
Teva Pharms Usa Inc	TIOPRONIN	tiopronin	TABLET;ORAL	214326-001	Apr 26, 2021	AB	RX	No	No
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes
Mission Pharma	THIOLA	tiopronin	TABLET;ORAL	019569-001	Aug 11, 1988	AB	RX	Yes	Yes

Tiopronin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tiopronin

Introduction

Tiopronin, a drug used primarily in the treatment of cystinuria and other kidney stone diseases, is an important player in the pharmaceutical market. To understand its market dynamics and financial trajectory, it is crucial to delve into various aspects including market size, growth drivers, key players, and financial performance.

Market Size and Growth

The global tiopronin market has been experiencing significant growth in recent years. The market size was valued at a substantial amount in 2022 and is forecasted to grow further by 2029, driven by increasing demand for effective treatments for rare diseases like cystinuria[3][4].

Key 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[3][4].

Key Players

Travere Therapeutics

Travere Therapeutics, although primarily known for its work on other drugs like sparsentan (FILSPARI), is also involved in the tiopronin market. Here are some key points related to their financial performance and market presence:

• Tiopronin Product Sales: Travere Therapeutics reports significant revenue from tiopronin products. For example, in the fourth quarter of 2021, net product sales for tiopronin products were $30.2 million, contributing to the company's total net product sales of $54.6 million[2].
• Annual Revenue: 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].

Financial Performance

Revenue Trends

• Quarterly Performance: In the second quarter of 2024, while the focus was on sparsentan, tiopronin continued to contribute to the company's revenue. Although specific Q2 2024 figures for tiopronin are not provided, the overall net product sales were $52.2 million, indicating a stable revenue stream[5].
• Annual Growth: The company has seen organic growth in net product sales, with a 6% increase in 2021 compared to the previous year. This growth is indicative of the stable demand for tiopronin[2].

Operating Expenses

• Research and Development (R&D) Expenses: R&D expenses are a significant component of the company's operating costs. In Q2 2024, R&D expenses were $54.3 million, reflecting ongoing investments in pipeline development, which indirectly supports the tiopronin market through overall company growth[5].
• Selling, General, and Administrative (SG&A) Expenses: SG&A expenses also play a crucial role. In Q2 2024, these expenses were $64.8 million, highlighting the company's efforts in marketing and distributing its products, including tiopronin[5].

Market Dynamics

Competitive Landscape

The tiopronin market is characterized by a competitive landscape with several manufacturers. The global market report highlights various manufacturers and their strategies, indicating a dynamic and competitive environment[3].

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][5].

Future Outlook

Growth Projections

The tiopronin market is projected to continue its growth trajectory from 2023 to 2029, driven by increasing demand and advancements in healthcare. The market is expected to expand significantly, making it an attractive segment for pharmaceutical companies[3][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.

Key Takeaways

• The tiopronin market is experiencing significant growth driven by increasing demand and advancements in healthcare.
• Travere Therapeutics is a key player, with substantial revenue from tiopronin products contributing to its overall financial performance.
• The market is competitive, with several manufacturers and a dynamic regulatory environment.
• Future growth projections are positive, with opportunities for expansion in new indications and markets.

FAQs

What is the primary use of tiopronin?

Tiopronin is primarily used in the treatment of cystinuria and other kidney stone diseases.

Which company is a key player in the tiopronin market?

Travere Therapeutics is a key player in the tiopronin market, although it is more prominently known for its work on other drugs like sparsentan.

What are the key drivers of the tiopronin market?

Key drivers include the increasing prevalence of kidney stone diseases, advancements in healthcare, and favorable regulatory environments.

What is the projected growth of the tiopronin market?

The tiopronin market is projected to grow significantly from 2023 to 2029, driven by increasing demand and healthcare advancements.

What are the major challenges faced by the tiopronin market?

Challenges include competition from generic drugs and the need for continuous R&D to maintain market share.

Sources

1. Tiopronin Market 2024: Industry Share, Key Drivers, and Forecast - Northeast News Channel Nebraska.
2. Travere Therapeutics Reports Fourth Quarter and Full Year 2021 - Travere Therapeutics.
3. Global Tiopronin Tablets Market 2023 by Manufacturers, Regions, Type and Application, Forecast to 2029 - Market Research Reports.
4. Global Tiopronin Market Size, Trends and Projections - Market Research Intellect.
5. Travere Therapeutics Reports Second Quarter 2024 Financial Results - Stock Titan.