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Last Updated: April 20, 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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL
Generic Entry Dates for tenapanor hydrochloride^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
Ardelyx	Phase 4
Ardelyx	Phase 2/Phase 3
Kyowa Hakko Kirin Co., Ltd	Phase 2

See all tenapanor hydrochloride clinical trials

Pharmacology for tenapanor hydrochloride

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 tenapanor hydrochloride

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

US Patents and Regulatory Information for tenapanor hydrochloride

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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	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	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	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		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				⤷ 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

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Country	Patent Number	Title	Estimated Expiration
South Korea	20150140386	NHE3-결합 화합물 및 포스페이트 수송을 저해하는 방법 (NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT)	⤷ Try a Trial
Brazil	PI0923861	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.	⤷ Try a Trial
China	102333759	Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	⤷ Try a Trial
South Korea	20160140994	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)	⤷ Try a Trial
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)	⤷ Try a Trial
>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.