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Last Updated: December 3, 2023

ISTURISA Drug Patent Profile


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Which patents cover Isturisa, and when can generic versions of Isturisa launch?

Isturisa is a drug marketed by Recordati Rare and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and thirty-four patent family members in forty-three countries.

The generic ingredient in ISTURISA is osilodrostat phosphate. One supplier is listed for this compound. Additional details are available on the osilodrostat phosphate profile page.

DrugPatentWatch® 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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  Try a Trial

Summary for ISTURISA
International Patents:134
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 50
Patent Applications: 54
Drug Prices: Drug price information for ISTURISA
What excipients (inactive ingredients) are in ISTURISA?ISTURISA excipients list
DailyMed Link:ISTURISA at DailyMed
Drug patent expirations by year for ISTURISA
Drug Prices for ISTURISA

See drug prices for ISTURISA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

ISTURISA is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ISTURISA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ISTURISA

Pharmaceutical dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CUSHING'S DISEASE

Organic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of an adrenal hormone-modifying agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CUSHING'S DISEASE

Organic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of an adrenal hormone-modifying agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting ISTURISA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 Mar 6, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ISTURISA

When does loss-of-exclusivity occur for ISTURISA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1116
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 15287336
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2016030243
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 54393
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 17000026
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6470704
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0181406
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20749
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 66596
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 17008187
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 3685
Estimated Expiration: ⤷  Try a Trial

Patent: 1790140
Estimated Expiration: ⤷  Try a Trial

Patent: 1991359
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 66596
Estimated Expiration: ⤷  Try a Trial

Patent: 12278
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 39037
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9374
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 31136
Estimated Expiration: ⤷  Try a Trial

Patent: 17520590
Estimated Expiration: ⤷  Try a Trial

Patent: 19194221
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 66596
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 16017315
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 170201
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 016502540
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 66596
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 66596
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201610227T
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 66596
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2468610
Estimated Expiration: ⤷  Try a Trial

Patent: 170029491
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 86704
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 07682
Estimated Expiration: ⤷  Try a Trial

Patent: 1613586
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 16000557
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ISTURISA around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2598708 ПРИМЕНЕНИЕ АГЕНТА, ОБЛАДАЮЩЕГО МОДИФИЦИРУЮЩИМИ СВОЙСТВАМИ В ОТНОШЕНИИ ГОРМОНОВ НАДПОЧЕЧНИКОВ (APPLICATION OF AGENT WITH MODIFYING PROPERTIES IN RELATION TO HORMONES OF ADRENAL GLANDS) ⤷  Try a Trial
South Korea 20170029491 제약 투여 형태 (PHARMACEUTICAL DOSAGE FORMS) ⤷  Try a Trial
European Patent Office 3527208 UTILISATION D'UN AGENT MODIFICATEUR D'HORMONE ADRÉNALE (USE OF AN ADRENAL HORMONE-MODIFYING AGENT) ⤷  Try a Trial
Japan 5225086 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ISTURISA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2523731 LUC00159 Luxembourg ⤷  Try a 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 CR 2020 00025 Denmark ⤷  Try a Trial PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731 400 50015-2020 Slovakia ⤷  Try a Trial PRODUCT NAME: OSILODROSTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731 20C1023 France ⤷  Try a 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
>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.