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Last Updated: September 22, 2020

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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

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

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
McKinsey
Mallinckrodt
Baxter
Dow

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