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IBSRELA Drug Profile
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Which patents cover Ibsrela, and when can generic versions of Ibsrela launch?
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. One supplier is listed for this compound. Additional details are available on the tenapanor hydrochloride profile page.
Summary for IBSRELA
| International Patents: | 34 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 17 |
| 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.
Synonyms for IBSRELA
| 1234423-95-0 |
| AZD 1722 |
| AZD 1722;AZD1722;AZD-1722;RDX5791;RDX 5791;RDX-5791 |
| AZD-1722 |
| AZD1722 |
| BCP24892 |
| BCP28554 |
| CHEMBL3304485 |
| CS-6273 |
| DB11761 |
| DTXSID40154016 |
| EX-A2506 |
| GTPL8449 |
| HY-15991 |
| J3.655.031G |
| MFCD28386333 |
| N,N'-(10,17,-Dioxo-3,6,21,24-tetraoxa-9,11,16,18-tetraazahexacosane-1,26-diyl)bis(((4S)-6,8-dichloro-2-methyl-1,2,3,4-tetrahydroisoquinolin-4-yl)benzenesulfonamide) |
| RDX 5791 |
| RDX-5791 |
| RDX5791 |
| SB19099 |
| SCHEMBL15267600 |
| Tenapanor |
| Tenapanor [USAN:INN] |
| Tenapanor; AZD1722; RDX5791 |
| UNII-WYD79216A6 |
| WYD79216A6 |
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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | 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 |
|---|---|---|
| Mexico | 2011007024 | Start Trial |
| Portugal | 2384318 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2018129556 | Start Trial |
| Mexico | 345283 | Start Trial |
| Denmark | 2384318 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
