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Last Updated: June 13, 2024

Tenapanor hydrochloride - Generic Drug Details


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What are the generic drug sources for tenapanor hydrochloride and what is the scope of freedom to operate?

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

Tenapanor hydrochloride has eighty-seven patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for tenapanor hydrochloride
International Patents:87
US Patents:6
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 18
Clinical Trials: 17
What excipients (inactive ingredients) are in tenapanor hydrochloride?tenapanor hydrochloride excipients list
DailyMed Link:tenapanor hydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tenapanor hydrochloride
Generic Entry Dates for tenapanor hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for tenapanor hydrochloride*:
Constraining patent/regulatory exclusivity:
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 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

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 XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-003 Oct 17, 2023 RX Yes Yes ⤷  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 213931-003 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 IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 RX Yes Yes ⤷  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 tenapanor hydrochloride

Country Patent Number Title Estimated Expiration
Taiwan 202123938 NHE3-binding compounds and methods for inhibiting phosphate transport ⤷  Sign Up
South Korea 20150140386 NHE3-결합 화합물 및 포스페이트 수송을 저해하는 방법 (NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT) ⤷  Sign Up
Japan 2018168165 NHE3結合化合物およびリン酸輸送の阻害方法 (NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT) ⤷  Sign Up
Japan 2016516779 NHE3結合化合物およびリン酸輸送の阻害方法 ⤷  Sign Up
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) ⤷  Sign Up
Israel 302151 תרכובות קושרות- nhe3 ושיטות לעיכוב הובלת פוספאט (תרכובות קושרות- nhe3 ושיטות לעיכוב הובלת פוספאט nhe3-binding compounds and methods for inhibiting phosphate transport) ⤷  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.