Details for New Drug Application (NDA): 211801
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NDA 211801 describes IBSRELA, which is a drug marketed by Ardelyx Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the IBSRELA profile page.
The generic ingredient in IBSRELA is tenapanor hydrochloride. One supplier is listed for this compound. Additional details are available on the tenapanor hydrochloride profile page.
The generic ingredient in IBSRELA is tenapanor hydrochloride. One supplier is listed for this compound. Additional details are available on the tenapanor hydrochloride profile page.
Summary for 211801
| Tradename: | IBSRELA |
| Applicant: | Ardelyx Inc |
| Ingredient: | tenapanor hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211801
Generic Entry Date for 211801*:
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.
Suppliers and Packaging for NDA: 211801
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801 | NDA | Ardelyx, Inc. | 73154-050 | 73154-050-06 | 6 TABLET in 1 BOTTLE (73154-050-06) |
| IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801 | NDA | Ardelyx, Inc. | 73154-050 | 73154-050-60 | 60 TABLET in 1 BOTTLE (73154-050-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Sep 12, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 12, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 12,016,856 | Patent Expiration: | Dec 30, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,541,448 | Patent Expiration: | Aug 1, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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