Details for New Drug Application (NDA): 211801
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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: | 4 |
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: | ⤷ Sign Up | Patent Expiration: | Aug 1, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 30, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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