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XPHOZAH Drug Patent Profile

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

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

This drug has eighty-seven patent family members in twenty-eight countries.

The generic ingredient in XPHOZAH 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 Xphozah

Xphozah 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 XPHOZAH

International Patents:	87
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for XPHOZAH
DailyMed Link:	XPHOZAH at DailyMed

See drug prices for XPHOZAH

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

Constraining patent/regulatory exclusivity:

8,541,448

NDA:

213931

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.

Pharmacology for XPHOZAH

Drug Class	Sodium-Hydrogen Exchanger 3 Inhibitor
Mechanism of Action	Organic Anion Transporting Polypeptide 2B1 Inhibitors Sodium-Hydrogen Exchanger 3 Inhibitors

US Patents and Regulatory Information for XPHOZAH

XPHOZAH is protected by seven US patents and two FDA Regulatory Exclusivities.

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	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No	10,940,146
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-002	Oct 17, 2023		RX	Yes	No
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-003	Oct 17, 2023		RX	Yes	Yes	12,016,856		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No	8,541,448		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-002	Oct 17, 2023		RX	Yes	No	10,272,079
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-003	Oct 17, 2023		RX	Yes	Yes	10,940,146

International Patents for XPHOZAH

When does loss-of-exclusivity occur for XPHOZAH?

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 XPHOZAH around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2748607	COMPOSES ET PROCEDES D'INHIBITION D'UN ANTIPORT A MEDIATION PAR NHE DANS LE TRAITEMENT DE TROUBLES ASSOCIES A UNE RETENTION DE FLUIDE OU A UNE SURCHARGE DE SEL ET DE TROUBLES DU T RACTUS 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)
Hungary	E036405
Japan	2012514009
China	102333759	Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Slovenia	2384318
Australia	2019204676	NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT
Croatia	P20180289

XPHOZAH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XPHOZAH

Introduction

XPHOZAH, developed by Ardelyx, is a significant addition to the treatment options for patients with hyperphosphatemia, particularly those undergoing dialysis. Since its approval by the U.S. Food and Drug Administration in October 2023, XPHOZAH has shown promising market dynamics and a robust financial trajectory.

Approval and Launch

XPHOZAH was approved by the FDA in October 2023 and launched in November of the same year. This timely approval and swift launch have been crucial in capturing market share quickly[1].

Initial Market Response

The initial response from the nephrology community has been strong. In the first quarter of commercialization, XPHOZAH generated approximately $2.5 million in U.S. net product sales revenue, setting a positive tone for its market adoption[1].

Quarterly Sales Growth

The sales growth of XPHOZAH has been remarkable:

• In the second quarter of 2024, XPHOZAH generated $37.1 million in U.S. net product sales revenue, showing significant quarter-over-quarter growth from the $15.2 million reported in the first quarter[4].
• By the third quarter of 2024, XPHOZAH's sales surged to $51.5 million, representing a 39% increase from the previous quarter[2][3].

Market Adoption and Clinical Positioning

The rapid uptake of XPHOZAH indicates a significant unmet need in the treatment of hyperphosphatemia among dialysis patients. The product's clinical positioning has been supported by multiple scientific presentations and publications, which have strengthened its evidence base and contributed to its market adoption[2].

Revenue Projections

For the full year 2024, while specific revenue guidance for XPHOZAH remains uncertain due to ongoing Medicare coverage developments, the current sales trend suggests a strong financial performance. The company's ability to secure additional financing and maintain a healthy cash position further supports its growth trajectory[3].

Challenges and Opportunities

Medicare Coverage

One of the significant challenges facing XPHOZAH is the Medicare coverage issue. The removal of Part D coverage for oral therapies starting January 1, 2025, poses a risk to future sales projections. However, Ardelyx is actively advocating for the Kidney Patient Act and has initiated legal action against CMS to address these coverage issues[3].

Legislative Support

The increasing legislative support for the Kidney Patient Act could positively impact Medicare coverage for XPHOZAH, potentially mitigating some of the challenges associated with coverage changes[3].

Financial Performance

Total Revenue

XPHOZAH's contribution to Ardelyx's total revenue has been substantial. In the third quarter of 2024, total revenue for the company was $98.2 million, with XPHOZAH generating $51.5 million of this amount. This represents a significant increase from the $56.4 million total revenue in the same period of 2023[2][5].

Cash Position

Ardelyx maintains a robust cash position, with $190.4 million in cash, cash equivalents, and short-term investments as of September 30, 2024. This financial stability is crucial for continuing the commercialization efforts and addressing any challenges that may arise[2][5].

Research and Development

Ardelyx continues to invest in research and development, with expenses increasing to $15.3 million in the third quarter of 2024 from $8.6 million in the same period of 2023. This investment is focused on medical engagement with scientific communities and pediatric clinical trials, further solidifying XPHOZAH's clinical evidence base[2][5].

Selling, General, and Administrative Expenses

The selling, general, and administrative expenses have increased significantly to $65.0 million in the third quarter of 2024, primarily due to the expansion of the commercial team and ongoing commercialization efforts for XPHOZAH and IBSRELA[2][5].

Net Loss

Despite the strong revenue growth, Ardelyx reported a net loss of $0.8 million in the third quarter of 2024, compared to a net income of $6.6 million in the same period of 2023. This is largely due to increased expenses associated with commercialization and research activities[2][5].

Key Takeaways

• Strong Sales Growth: XPHOZAH has shown significant quarter-over-quarter sales growth, reaching $51.5 million in the third quarter of 2024.
• Market Adoption: The product has seen strong adoption in the nephrology community, addressing a significant unmet need in hyperphosphatemia treatment.
• Challenges: Medicare coverage issues pose a risk, but Ardelyx is actively addressing these through advocacy and legal actions.
• Financial Stability: The company maintains a healthy cash position, supporting continued commercialization and R&D efforts.
• Legislative Support: Increasing support for the Kidney Patient Act could positively impact Medicare coverage for XPHOZAH.

FAQs

1. What is XPHOZAH used for? XPHOZAH is used to treat hyperphosphatemia in patients with chronic kidney disease on dialysis.

2. When was XPHOZAH approved by the FDA? XPHOZAH was approved by the FDA in October 2023.

3. How has XPHOZAH performed in terms of sales? XPHOZAH generated $2.5 million in the first quarter, $37.1 million in the second quarter, and $51.5 million in the third quarter of 2024, showing significant growth.

4. What are the challenges facing XPHOZAH's sales? The main challenge is the Medicare coverage issue, specifically the removal of Part D coverage for oral therapies starting January 1, 2025.

5. How is Ardelyx addressing the Medicare coverage issues for XPHOZAH? Ardelyx is advocating for the Kidney Patient Act and has initiated legal action against CMS to address these coverage issues.

Sources

1. Ardelyx Provides Update on Growing Commercial Momentum and Financial Results - Ardelyx IR.
2. Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update - Stock Titan.
3. Earnings call: Ardelyx reports solid growth amid Medicare challenges - Investing.com.
4. Ardelyx Reports Second Quarter 2024 Financial Results and Provides Business Update - BioSpace.
5. Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update - Ardelyx IR.