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Last Updated: October 26, 2021

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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 thirty-two patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for osilodrostat phosphate
International Patents:132
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 4
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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for osilodrostat phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2523731 C202030030 Spain ⤷  Free Forever Trial PRODUCT NAME: OSILODROSTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUIDO EL OSILODROSTAT DIHIDROGENO FOSFATO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1407; DATE OF AUTHORISATION: 20200109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1407; DATE OF FIRST AUTHORISATION IN EEA: 20200109
2523731 20C1023 France ⤷  Free Forever Trial PRODUCT NAME: OSILODROSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731 CA 2020 00025 Denmark ⤷  Free Forever Trial PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731 LUC00159 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: OSILODROSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; AUTHORISATION NUMBER AND DATE: EU/1/19/1407 20200113
2523731 2020/020 Ireland ⤷  Free Forever Trial PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE.; REGISTRATION NO/DATE: EU/1/19/1407 20200113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
McKinsey
Mallinckrodt
Baxter
Dow

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