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Last Updated: October 6, 2022

Tenapanor hydrochloride - Generic Drug Details


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What are the generic sources for tenapanor hydrochloride and what is the scope of patent protection?

Tenapanor hydrochloride is the generic ingredient in one branded drug marketed by Ardelyx Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tenapanor hydrochloride has thirty-seven patent family members in twenty-one countries.

Summary for tenapanor hydrochloride
International Patents:37
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 15
What excipients (inactive ingredients) are in tenapanor hydrochloride?tenapanor hydrochloride excipients list
DailyMed Link:tenapanor hydrochloride at DailyMed
Recent Clinical Trials for tenapanor hydrochloride

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

SponsorPhase
ArdelyxPhase 4
ArdelyxPhase 2/Phase 3
Kyowa Hakko Kirin Co., LtdPhase 2

See all tenapanor hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for tenapanor hydrochloride

US Patents and Regulatory Information for tenapanor hydrochloride

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 tenapanor hydrochloride

Country Patent Number Title Estimated Expiration
South Korea 20170091783 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) See Plans and Pricing
Spain 2657938 See Plans and Pricing
European Patent Office 3939964 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) See Plans and Pricing
Hong Kong 1198162 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
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Merck
Medtronic
Boehringer Ingelheim

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