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Last Updated: February 2, 2023

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-four patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for osilodrostat phosphate
International Patents:134
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 5
Patent Applications: 7
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No See Plans and Pricing See Plans and Pricing 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 osilodrostat phosphate

Country Patent Number Title Estimated Expiration
Turkey 201900515 See Plans and Pricing
Mexico 2012008212 USO DE UN AGENTE MODIFICADOR DE HORMONAS SUPRARRENALES. (USE OF AN ADRENAL HORMONE-MODIFYING AGENT.) See Plans and Pricing
Israel 189024 תולדות 5-פניל-7,6-דיהידרו-h5-פירול [2,1-c] אימידאזול ותכשירים רפואיים המכילים אותן (5-phenyl-6,7-dihydro-5h-pyrrolo[1,2-c]imidazole derivatives and pharmaceutical compositions comprising them) See Plans and Pricing
Slovenia 3166596 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for osilodrostat phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2523731 C202030030 Spain See Plans and Pricing 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 PA2020512,C2523731 Lithuania See Plans and Pricing PRODUCT NAME: OSILODROSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT OSILODROSTATO DIHIDROFOSFATA; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731 2020/020 Ireland See Plans and Pricing PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE.; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731 301043 Netherlands See Plans and Pricing 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.