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-three 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
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 |


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.
Anatomical Therapeutic Chemical (ATC) Classes for ISTURISA
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
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 |