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Osilodrostat phosphate - Generic Drug Details
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What are the generic sources for osilodrostat phosphate and what is the scope of freedom to operate?
Osilodrostat phosphate
is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Osilodrostat phosphate has one hundred and twenty-three patent family members in forty countries.
One supplier is listed for this compound.
Summary for osilodrostat phosphate
| International Patents: | 123 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 2 |
| Patent Applications: | 4 |
| DailyMed Link: | osilodrostat phosphate at DailyMed |
US Patents and Regulatory Information for osilodrostat phosphate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-003 | Mar 6, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-003 | Mar 6, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-001 | Mar 6, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-003 | Mar 6, 2020 | 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 osilodrostat phosphate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20170029491 | Start Trial |
| Spain | 2707596 | Start Trial |
| Japan | 6181610 | Start Trial |
| European Patent Office | 2256118 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for osilodrostat phosphate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2523731 | CA 2020 00025 | Denmark | Start Trial | PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113 |
| 2523731 | 301043 | Netherlands | Start Trial | PRODUCT NAME: OSILODROSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN OSILODROSTATDIWATERSTOFFOSFAAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
