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XPHOZAH Drug Patent Profile

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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 four patents protecting this drug.

This drug has eighty-five 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

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Summary for XPHOZAH

International Patents:	85
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for XPHOZAH
DailyMed Link:	XPHOZAH at DailyMed

Drug patent expirations by year for XPHOZAH

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

Generic Entry Date for XPHOZAH^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Anatomical Therapeutic Chemical (ATC) Classes for XPHOZAH

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

US Patents and Regulatory Information for XPHOZAH

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XPHOZAH is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XPHOZAH

NHE3-binding compounds and methods for inhibiting phosphate transport
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERPHOSPHATEMIA

NHE3-binding compounds and methods for inhibiting phosphate transport
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF SERUM PHOSPHORUS IN ADULTS

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERPHOSPHATEMIA

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF SERUM PHOSPHORUS IN ADULTS

Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting XPHOZAH

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

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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
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-003	Oct 17, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-003	Oct 17, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

Patent: 09334511
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0923861
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 48607
Estimated Expiration: ⤷ Try a Trial

China

Patent: 2333759
Estimated Expiration: ⤷ Try a Trial

Patent: 3819403
Estimated Expiration: ⤷ Try a Trial

Croatia

Patent: 0180289
Estimated Expiration: ⤷ Try a Trial

Cyprus

Patent: 20451
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 84318
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 84318
Estimated Expiration: ⤷ Try a Trial

Patent: 51248
Estimated Expiration: ⤷ Try a Trial

Patent: 39964
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 98162
Estimated Expiration: ⤷ Try a Trial

Hungary

Patent: 36405
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 3852
Estimated Expiration: ⤷ Try a Trial

Patent: 0641
Estimated Expiration: ⤷ Try a Trial

Patent: 9851
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 02106
Estimated Expiration: ⤷ Try a Trial

Patent: 05802
Estimated Expiration: ⤷ Try a Trial

Patent: 12514009
Estimated Expiration: ⤷ Try a Trial

Patent: 14114300
Estimated Expiration: ⤷ Try a Trial

Lithuania

Patent: 84318
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 5283
Estimated Expiration: ⤷ Try a Trial

Patent: 11007024
Estimated Expiration: ⤷ Try a Trial

Norway

Patent: 84318
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 84318
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 84318
Estimated Expiration: ⤷ Try a Trial

Slovenia

Patent: 84318
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1683318
Estimated Expiration: ⤷ Try a Trial

Patent: 1766619
Estimated Expiration: ⤷ Try a Trial

Patent: 110110287
Estimated Expiration: ⤷ Try a Trial

Patent: 160140994
Estimated Expiration: ⤷ Try a Trial

Patent: 170091783
Estimated Expiration: ⤷ Try a Trial

Patent: 200111230
Estimated Expiration: ⤷ Try a Trial

Patent: 220042487
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 57938
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20210117282	NHE3-결합 화합물 및 포스페이트 수송을 저해하는 방법 (NHE3- NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT)	⤷ Try a Trial
Poland	2384318		⤷ Try a Trial
New Zealand	713688	Nhe3-binding compounds and methods for inhibiting phosphate transport	⤷ Try a Trial
Cyprus	1120451		⤷ Try a Trial
Israel	241959	Bis- [3-(6,8-dichloro-2-methyl-1,2,3,4-tetrahydro-isoquinolin-4-yl)-benzenesulfinic acid (2-{2-[2-(3-ethyl-ureido)-ethoxy]-ethoxy}-ethyl)-amide] compound for use in treating hyperphosphatemia	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for XPHOZAH

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

Pharmacology for XPHOZAH

Anatomical Therapeutic Chemical (ATC) Classes for XPHOZAH

Patents protecting XPHOZAH

FDA Regulatory Exclusivity protecting XPHOZAH

When does loss-of-exclusivity occur for XPHOZAH?

Make Better Decisions: Try a trial or see plans & pricing

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