Tenapanor hydrochloride - Generic Drug Details

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 seven 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:	7
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	18
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

Dosage:

TABLET;ORAL

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
Kyle Staller, MD, MPH	Phase 4
Ardelyx	Phase 4
Ardelyx	Phase 2/Phase 3

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

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			Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-002	Oct 17, 2023		RX	Yes	No
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No			Y	Y
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-003	Oct 17, 2023		RX	Yes	Yes
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-002	Oct 17, 2023		RX	Yes	No

International Patents for tenapanor hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Africa	201508006	NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT
Mexico	2011007024	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.)
European Patent Office	2983667	COMPOSÉS DE LIAISON À NHE3 ET PROCÉDÉS D'INHIBITION DU TRANSPORT DE PHOSPHATE (NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT)
Uruguay	35532	COMPUESTOS DE UNIÓN A NHE3 Y MÉTODOS PARA INHIBIR EL TRANSPORTE DE FOSFATO
Cyprus	1121929
South Korea	20220042487	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)
Canada	2748607	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)