Details for New Drug Application (NDA): 213931
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NDA 213931 describes XPHOZAH, which is a drug marketed by Ardelyx Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the XPHOZAH profile page.
The generic ingredient in XPHOZAH is tenapanor hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tenapanor hydrochloride profile page.
The generic ingredient in XPHOZAH is tenapanor hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tenapanor hydrochloride profile page.
Summary for 213931
| Tradename: | XPHOZAH |
| Applicant: | Ardelyx Inc |
| Ingredient: | tenapanor hydrochloride |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213931
Generic Entry Date for 213931*:
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.
Pharmacology for NDA: 213931
Suppliers and Packaging for NDA: 213931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XPHOZAH | tenapanor hydrochloride | TABLET;ORAL | 213931 | NDA | Ardelyx, Inc. | 73154-110 | 73154-110-14 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-14) |
| XPHOZAH | tenapanor hydrochloride | TABLET;ORAL | 213931 | NDA | Ardelyx, Inc. | 73154-110 | 73154-110-60 | 60 TABLET, FILM COATED in 1 BOTTLE (73154-110-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Oct 17, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 17, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 10, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF SERUM PHOSPHORUS IN ADULTS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 10, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPERPHOSPHATEMIA | ||||||||
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