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Harvard Business School

Last Updated: September 27, 2020

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ISTURISA Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Isturisa

Isturisa will be eligible for patent challenges on March 6, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ISTURISA
International Patents:123
US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 23
Patent Applications: 34
Drug Prices: Drug price information for ISTURISA
DailyMed Link:ISTURISA at DailyMed
Drug patent expirations by year for ISTURISA
Drug Prices for ISTURISA

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Generic Entry Opportunity Date for ISTURISA
Generic Entry Date for ISTURISA*:
Constraining patent/regulatory exclusivity:
NDA:
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 ISTURISA

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 212801-001 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
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 RX Yes Yes   Start Trial   Start Trial   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 212801-001 Mar 6, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No   Start Trial   Start Trial Y Y   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 ISTURISA

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:

Johnson and Johnson
McKinsey
Express Scripts
AstraZeneca
Baxter
Dow

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.