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IBSRELA Drug Patent Profile

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

Ibsrela is a drug marketed by Ardelyx Inc and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-seven patent family members in twenty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ibsrela

Ibsrela was eligible for patent challenges on September 12, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 1, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IBSRELA

International Patents:	37
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	1
Drug Prices:	Drug price information for IBSRELA
What excipients (inactive ingredients) are in IBSRELA?	IBSRELA excipients list
DailyMed Link:	IBSRELA at DailyMed

See drug prices for IBSRELA

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

Constraining patent/regulatory exclusivity:

8,541,448

NDA:

211801

Dosage:

TABLET;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 IBSRELA

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

Sponsor	Phase
Ardelyx	Phase 3

See all IBSRELA clinical trials

US Patents and Regulatory Information for IBSRELA

IBSRELA is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,541,448.

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
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes	9,006,281
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes	12,016,856		Y	Y
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes	9,408,840
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes	8,969,377		Y	Y
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes

International Patents for IBSRELA

When does loss-of-exclusivity occur for IBSRELA?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Norway

Poland

Portugal

Slovenia

South Korea

Spain

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 IBSRELA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3351248	COMPOSÉS ET PROCÉDÉS D'INHIBITION D'UN ANTIPORT À MÉDIATION PAR NHE DANS LE TRAITEMENT DE TROUBLES ASSOCIÉS À UNE RÉTENTION DE FLUIDE OU À UNE SURCHARGE DE SEL ET DE TROUBLES DU TRACTUS GASTRO-INTESTINAL (COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Brazil	PI0923861	Compostos e métodos para inibir o antiporte nhe-mediado no tratamento de distúrbios associados com a retenção de líquidos ou com a sobrecarga de sal e distúrbios do trato gastrointestinal.
Hungary	E036405
European Patent Office	2384318	COMPOSÉS ET PROCÉDÉS D'INHIBITION D'UN ANTIPORT À MÉDIATION PAR NHE DANS LE TRAITEMENT DE TROUBLES ASSOCIÉS À UNE RÉTENTION DE FLUIDE OU À UNE SURCHARGE DE SEL ET DE TROUBLES DU TRACTUS GASTRO-INTESTINAL (COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Portugal	2384318

IBSRELA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IBSRELA

Introduction

IBSRELA, developed by Ardelyx, is a significant treatment option for patients with irritable bowel syndrome with constipation (IBS-C). Here, we delve into the market dynamics and financial trajectory of IBSRELA, highlighting its growth, revenue performance, and future projections.

Product Overview

IBSRELA (tenapanor) is a small molecule that works by inhibiting the sodium-hydrogen exchanger 3 (NHE3) in the intestine, which helps to increase intestinal fluid and promote bowel movements. This mechanism makes it an effective treatment for IBS-C patients[3].

Market Growth and Adoption

Since its launch, IBSRELA has demonstrated consistent and robust growth. Here are some key indicators of its market adoption:

• Quarter-over-Quarter Growth: IBSRELA has shown persistent quarter-over-quarter growth. For instance, in Q3 2023, it achieved a 22% increase in net sales revenue compared to the previous quarter[4].
• Year-over-Year Growth: The product has seen significant year-over-year growth. In Q3 2024, IBSRELA generated $40.6 million in net product sales, a substantial increase from $22.3 million in the same period of 2023[2].

Revenue Performance

The revenue performance of IBSRELA has been strong and steadily increasing:

• 2023 Revenue Guidance: Ardelyx initially guided for full-year 2023 U.S. net sales revenue for IBSRELA to be between $72 and $77 million. This guidance was later adjusted to reflect the product's strong performance[3].
• Q3 2023 Revenue: In the third quarter of 2023, IBSRELA generated $22.3 million in U.S. net sales revenue, marking a 22% quarter-over-quarter increase[4].
• 2024 Revenue Projections: For 2024, Ardelyx expects full-year U.S. net product sales revenue for IBSRELA to be between $140 and $150 million, indicating a significant growth trajectory[2][5].

Market Share and Peak Sales Expectations

Ardelyx is optimistic about IBSRELA's market share and peak sales potential:

• Market Share: The company expects IBSRELA to achieve greater than 10% market share at peak[1].
• Peak Sales: IBSRELA is projected to generate more than $1.0 billion in annual U.S. net product sales revenue before patent term expiration[1].

Commercial Strategies

To support the continued growth of IBSRELA, Ardelyx has implemented several commercial strategies:

• Sales Team Expansion: The company plans to expand the IBSRELA sales team to enhance its reach and penetration in the market[1].
• Promotional Programming: Additional promotional programming and omnichannel digital capabilities are being invested in to increase awareness and adoption of IBSRELA[1].
• Sampling and Patient Support: Increased sampling availability and expanded support through the ArdelyxAssist™ patient services program are also part of the strategy[1].

Financial Health and Funding

Ardelyx's financial health and access to funding are crucial for the continued success of IBSRELA:

• Cash Position: As of September 30, 2024, the company had a strong cash position with $190.4 million in total cash, cash equivalents, and short-term investments[2].
• Financing Agreements: Ardelyx has secured additional financing through an amended loan agreement with SLR Capital Partners, providing access to up to $100 million[2].

Research and Development

While IBSRELA is a key focus, Ardelyx continues to invest in research and development to advance its business:

• R&D Expenses: Research and development expenses have increased, reflecting the company's commitment to advancing its pipeline and supporting the growth of its marketed therapies[2][5].

Challenges and Opportunities

Despite the strong performance, there are challenges and opportunities to consider:

• SG&A Expenses: Selling, general, and administrative expenses have increased significantly due to the ongoing commercialization efforts for IBSRELA and XPHOZAH. This increase is a challenge but also reflects the company's investment in growth[2][5].
• Competition: The IBS-C market is competitive, but IBSRELA's unique mechanism and growing market share position it well for continued success.

International Expansion

Ardelyx is also focusing on international expansion to further grow its revenue:

• Licensing Agreements: The company has received milestone payments from partners like Kyowa Kirin and Fosun Pharma, reflecting its global reach and potential for additional revenue streams[4].

Key Takeaways

• Consistent Growth: IBSRELA has shown consistent quarter-over-quarter and year-over-year growth.
• Strong Revenue Performance: The product is expected to generate between $140 and $150 million in U.S. net product sales revenue for 2024.
• Market Share and Peak Sales: IBSRELA is projected to achieve greater than 10% market share and generate over $1 billion in annual peak sales.
• Commercial Strategies: Ardelyx is investing in sales team expansion, promotional programming, and patient support to drive growth.
• Financial Health: The company has a strong cash position and access to additional financing.

FAQs

1. What is IBSRELA used for? IBSRELA (tenapanor) is used for the treatment of irritable bowel syndrome with constipation (IBS-C).

2. How has IBSRELA performed in terms of revenue? IBSRELA has shown strong revenue growth, with Q3 2024 net product sales of $40.6 million, a 15% quarter-over-quarter increase.

3. What are the peak sales expectations for IBSRELA? Ardelyx expects IBSRELA to generate more than $1.0 billion in annual U.S. net product sales revenue before patent term expiration.

4. How is Ardelyx supporting the growth of IBSRELA? The company is expanding its sales team, increasing promotional programming, enhancing sampling availability, and expanding patient support through the ArdelyxAssist™ program.

5. What is the current cash position of Ardelyx? As of September 30, 2024, Ardelyx had $190.4 million in total cash, cash equivalents, and short-term investments.

Sources

1. Ardelyx Provides Update on Growing Commercial Momentum and ... - Ardelyx IR[1]
2. Ardelyx Reports Third Quarter 2024 Financial Results and Provides ... - Stock Titan[2]
3. Ardelyx Reports Second Quarter 2023 Financial Results ... - BioSpace[3]
4. Ardelyx Reports Third Quarter 2023 Financial Results and Updates ... - BioSpace[4]
5. Ardelyx Reports Second Quarter 2024 Financial Results and ... - GlobeNewswire[5]