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Last Updated: February 25, 2024

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 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-five patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for tenapanor hydrochloride
International Patents:85
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 Kirin Co., Ltd.Phase 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 XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-001 Oct 17, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-002 Oct 17, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-003 Oct 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-002 Oct 17, 2023 RX Yes No ⤷  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 tenapanor hydrochloride

Country Patent Number Title Estimated Expiration
Denmark 2983667 ⤷  Try a Trial
China 105392483 NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT ⤷  Try a Trial
Norway 2384318 ⤷  Try a Trial
Croatia P20180289 ⤷  Try a Trial
Hong Kong 1221400 用於抑制磷酸鹽轉運的 結合化合物和方法 (NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT NHE3) ⤷  Try a Trial
South Korea 20150140386 NHE3-결합 화합물 및 포스페이트 수송을 저해하는 방법 (NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
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Boehringer Ingelheim

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.