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IBSRELA Drug Profile
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When do Ibsrela patents expire, and what generic alternatives are available?
Ibsrela is a drug marketed by Ardelyx Inc and is included in one NDA. There are four patents protecting this drug.
This drug has thirty-four patent family members in twenty-one countries.
The generic ingredient in IBSRELA is tenapanor hydrochloride. Additional details are available on the tenapanor hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Ibsrela
Ibsrela will be eligible for patent challenges on September 12, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 30, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for IBSRELA
| International Patents: | 34 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 18 |
| Patent Applications: | 6 |
| DailyMed Link: | IBSRELA at DailyMed |
Generic Entry Opportunity Date for IBSRELA
Generic Entry Date for IBSRELA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for IBSRELA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | DISCN | Yes | No | Start Trial | Start Trial | Start 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 IBSRELA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2384318 | Start Trial |
| Spain | 2657938 | Start Trial |
| Poland | 2384318 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
