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Last Updated: June 13, 2024

Osilodrostat phosphate - Generic Drug Details


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What are the generic sources for osilodrostat phosphate and what is the scope of patent protection?

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-five patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for osilodrostat phosphate
International Patents:135
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 8
Patent Applications: 7
DailyMed Link:osilodrostat phosphate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for osilodrostat phosphate
Generic Entry Date for osilodrostat phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 212801-002 Mar 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 Mar 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 Mar 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 Mar 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Singapore 11201610227T PHARMACEUTICAL DOSAGE FORMS ⤷  Sign Up
South Korea 20170029491 제약 투여 형태 (PHARMACEUTICAL DOSAGE FORMS) ⤷  Sign Up
Slovenia 2523731 ⤷  Sign Up
Hungary E041967 ⤷  Sign Up
South Korea 102468610 ⤷  Sign Up
Chile 2012001961 Método para tratar una enfermedad o trastorno en que aumentan los niveles de hormonas de estrés y/o disminuyen los niveles de hormonas de andrógenos, en que se administra un compuesto pirrolo-[1,2-c]-imidazol-bencil sustituido; su uso en insuficiencia cardíaca, entre otros; y compuestos pirrolo-[1,2-c]-imidazol-bencil sustituidos. ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for osilodrostat phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2523731 C20200013 00309 Estonia ⤷  Sign Up PRODUCT NAME: OSILODROSTAAT;REG NO/DATE: EU/1/19/1407 13.01.2020
2523731 132020000000052 Italy ⤷  Sign Up PRODUCT NAME: OSILODROSTAT(ISTURISA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1407, 20200113
2523731 LUC00159 Luxembourg ⤷  Sign Up 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 2020012 Norway ⤷  Sign Up PRODUCT NAME: OSILODROSTAT ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, INKLUDERT OSILODROSTAT DIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200203
2523731 301043 Netherlands ⤷  Sign Up PRODUCT NAME: OSILODROSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN OSILODROSTATDIWATERSTOFFOSFAAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731 C202030030 Spain ⤷  Sign Up 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
>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.