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Tenapanor hydrochloride - Generic Drug Details
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What are the generic drug sources for tenapanor hydrochloride and what is the scope of freedom to operate?
Tenapanor hydrochloride
is the generic ingredient in one branded drug marketed by Ardelyx Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tenapanor hydrochloride has thirty-four patent family members in twenty-one countries.
Summary for tenapanor hydrochloride
| International Patents: | 34 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 13 |
| DailyMed Link: | tenapanor hydrochloride at DailyMed |
Recent Clinical Trials for tenapanor hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ardelyx | Phase 4 |
| Ardelyx | Phase 2/Phase 3 |
| Kyowa Hakko Kirin Co., Ltd | Phase 2 |
US Patents and Regulatory Information for tenapanor hydrochloride
| 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 | 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 | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | 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 tenapanor hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2748607 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2018129556 | Start Trial |
| Croatia | P20180289 | Start Trial |
| European Patent Office | 2384318 | Start Trial |
| South Korea | 20110110287 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
