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-seven patent family members in twenty-one countries.
One supplier is listed for this compound.
Summary for tenapanor hydrochloride
| International Patents: | 37 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Clinical Trials: | 16 |
| Patent Applications: | 1 |
| What excipients (inactive ingredients) are in tenapanor hydrochloride? | tenapanor hydrochloride excipients list |
| 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 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 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| >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 | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 101766619 | See Plans and Pricing | |
| South Korea | 101683318 | See Plans and Pricing | |
| South Korea | 20220042487 | 체액 저류 또는 염 과부하와 연관된 장애 및 위장관 장애의 치료 시에 ＮＨＥ-매개된 역수송을 억제하는 화합물 및 방법 (- COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS) | See Plans and Pricing |
| Japan | 5805802 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
