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Last Updated: November 5, 2024

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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 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

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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
Drug patent expirations by year for XPHOZAH
Drug Prices for XPHOZAH

See drug prices for XPHOZAH

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XPHOZAH
Generic Entry Date for XPHOZAH*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for XPHOZAH

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

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERPHOSPHATEMIA

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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERPHOSPHATEMIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: REDUCTION OF SERUM PHOSPHORUS IN ADULTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting XPHOZAH

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-002 Oct 17, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-003 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-001 Oct 17, 2023 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-002 Oct 17, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Patent: Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0923861
Patent: 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.
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 48607
Patent: 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)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2333759
Patent: Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Estimated Expiration: ⤷  Sign Up

Patent: 3819403
Patent: Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0180289
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20451
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 84318
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 84318
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 51248
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 39964
Patent: COMBINAISONS 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 TRACTUS GASTRO-INTESTINAL (COMBINATIONS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 98162
Patent: 用於治療與體液瀦留或鹽超負荷有關的病症和胃腸道病症的化合物和方法 (COMPOUNDS AND METHODS IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 36405
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3852
Patent: תרכובות ושיטות לעיכוב אנטיפורט מתווך nhe בטיפול בהפרעות הקשורות לאצירת נוזלים או עומס יתר של מלחים ואי-סדרים במערכת העיכול (Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders)
Estimated Expiration: ⤷  Sign Up

Patent: 0641
Patent: תכשירי רוקחות לעיכוב אנטיפורט מתווך nhe בטיפול בהפרעות הקשורות לאצירת נוזלים או עומס יתר של מלחים ואי-סדרים במערכת העיכול (Pharmaceutical compositions for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders)
Estimated Expiration: ⤷  Sign Up

Patent: 9851
Patent: תרכובות ושיטות לעיכוב אנטיפורט מתווך nhe בטיפול בהפרעות הקשורות לאצירת נוזלים או עומס יתר של מלחים ואי-סדרים במערכת העיכול (Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 02106
Estimated Expiration: ⤷  Sign Up

Patent: 05802
Estimated Expiration: ⤷  Sign Up

Patent: 12514009
Estimated Expiration: ⤷  Sign Up

Patent: 14114300
Patent: COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 84318
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 5283
Patent: COMPUESTOS Y METODOS PARA INHIBIR EL ANTIPORTE MEDIADO POR INTERCAMBIADOR DE IONES DE SODIO/IONES DE HIDROGENO (NHE) EN EL TRATAMIENTO DE TRASTORNOS ASOCIADOS CON RETENCION DE FLUIDO O SOBRECARGA DE SAL Y TRASTORNOS DEL TRACTO GASTROINTESTINAL. (COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS.)
Estimated Expiration: ⤷  Sign Up

Patent: 11007024
Patent: COMPUESTOS Y METODOS PARA INHIBIR EL ANTIPORTE MEDIADO POR INTERCAMBIADOR DE IONES DE SODIO/IONES DE HIDROGENO (NHE) EN EL TRATAMIENTO DE TRASTORNOS ASOCIADOS CON RETENCION DE FLUIDO O SOBRECARGA DE SAL Y TRASTORNOS DEL TRACTO GASTROINTESTINAL. (COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS.)
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 84318
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 84318
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 84318
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 84318
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1683318
Estimated Expiration: ⤷  Sign Up

Patent: 1766619
Estimated Expiration: ⤷  Sign Up

Patent: 110110287
Patent: COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS
Estimated Expiration: ⤷  Sign Up

Patent: 160140994
Patent: 체액 저류 또는 염 과부하와 연관된 장애 및 위장관 장애의 치료 시에 NHE-매개된 역수송을 억제하는 화합물 및 방법 (- COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 170091783
Patent: 체액 저류 또는 염 과부하와 연관된 장애 및 위장관 장애의 치료 시에 NHE-매개된 역수송을 억제하는 화합물 및 방법 (- COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 200111230
Patent: 체액 저류 또는 염 과부하와 연관된 장애 및 위장관 장애의 치료 시에 NHE-매개된 역수송을 억제하는 화합물 및 방법 (- COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 220042487
Patent: 체액 저류 또는 염 과부하와 연관된 장애 및 위장관 장애의 치료 시에 NHE-매개된 역수송을 억제하는 화합물 및 방법 (- COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 57938
Estimated Expiration: ⤷  Sign Up

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
Portugal 2384318 ⤷  Sign Up
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 ⤷  Sign Up
South Korea 20110110287 COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS ⤷  Sign Up
Australia 2014250956 NHE3-binding compounds and methods for inhibiting phosphate transport ⤷  Sign Up
China 103819403 Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.