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Last Updated: August 10, 2022

ISTURISA Drug Patent Profile


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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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Summary for ISTURISA
International Patents:133
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 33
Patent Applications: 46
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 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

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CUSHING'S DISEASE

Organic compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of an adrenal hormone-modifying agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CUSHING'S DISEASE

Organic compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of an adrenal hormone-modifying agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ISTURISA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: 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
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 Mar 6, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
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 212801-003 Mar 6, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 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 212801-001 Mar 6, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 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: See Plans and Pricing

Australia

Patent: 15287336
Estimated Expiration: See Plans and Pricing

Canada

Patent: 54393
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17000026
Estimated Expiration: See Plans and Pricing

China

Patent: 6470704
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0181406
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20749
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 66596
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17008187
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 3685
Estimated Expiration: See Plans and Pricing

Patent: 1790140
Estimated Expiration: See Plans and Pricing

Patent: 1991359
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 66596
Estimated Expiration: See Plans and Pricing

Patent: 12278
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 39037
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9374
Estimated Expiration: See Plans and Pricing

Japan

Patent: 31136
Estimated Expiration: See Plans and Pricing

Patent: 17520590
Estimated Expiration: See Plans and Pricing

Patent: 19194221
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 66596
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 16017315
Estimated Expiration: See Plans and Pricing

Peru

Patent: 170201
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 016502540
Estimated Expiration: See Plans and Pricing

Poland

Patent: 66596
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 66596
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201610227T
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 66596
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170029491
Estimated Expiration: See Plans and Pricing

Spain

Patent: 86704
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 07682
Estimated Expiration: See Plans and Pricing

Patent: 1613586
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 16000557
Estimated Expiration: See Plans and Pricing

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
Brazil 112012017458 uso de um agente de modificação de hormônio adrenal See Plans and Pricing
Portugal 3166596 See Plans and Pricing
Poland 1919916 See Plans and Pricing
Australia 2015287336 Pharmaceutical dosage forms See Plans and Pricing
Canada 2954393 FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ISTURISA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2523731 CA 2020 00025 Denmark See Plans and Pricing PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731 122020000026 Germany See Plans and Pricing PRODUCT NAME: OSILODROSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731 20C1023 France See Plans and Pricing 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
2523731 C20200013 00309 Estonia See Plans and Pricing PRODUCT NAME: OSILODROSTAAT;REG NO/DATE: EU/1/19/1407 13.01.2020
2523731 PA2020512 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.