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-five 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 was eligible for patent challenges on March 6, 2024.
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ISTURISA?
- What are the global sales for ISTURISA?
- What is Average Wholesale Price for ISTURISA?
Summary for ISTURISA
International Patents: | 135 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Patent Applications: | 121 |
Drug Prices: | Drug price information for ISTURISA |
What excipients (inactive ingredients) are in ISTURISA? | ISTURISA excipients list |
DailyMed Link: | ISTURISA at DailyMed |
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.
Pharmacology 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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: CUSHING'S DISEASE
Organic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of an adrenal hormone-modifying agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: CUSHING'S DISEASE
Organic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of an adrenal hormone-modifying agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting ISTURISA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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 | ⤷ 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 | ⤷ Sign Up | ||||
Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-003 | Mar 6, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 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
Patent: FORMAS DE DOSIFICACIÓN FARMACÉUTICAS PARA ADMINISTRACIÓN ORAL
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 15287336
Patent: Pharmaceutical dosage forms
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016030243
Patent: FORMAS DE DOSAGEM FARMACÊUTICAS, SEU PROCESSO DE PREPARAÇÃO, E USOS DE CELULOSE MICROCRISTALINA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 54393
Patent: FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 17000026
Patent: Formas de dosificación farmacéutica
Estimated Expiration: ⤷ Sign Up
China
Patent: 6470704
Patent: 药物剂型 (Pharmaceutical dosage forms)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181406
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20749
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 66596
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 17008187
Patent: FORMAS DE DOSIFICACIÓN FARMACÉUTICA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 3685
Patent: ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 1790140
Patent: ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ
Estimated Expiration: ⤷ Sign Up
Patent: 1991359
Patent: ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 66596
Patent: FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 12278
Patent: FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 39037
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9374
Patent: צורות מתן רוקחיות המכילה מיקרוקרסטליין צלולוז (Pharmaceutical dosage forms comprising microcrystalline cellulose)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 31136
Estimated Expiration: ⤷ Sign Up
Patent: 17520590
Patent: 医薬製剤
Estimated Expiration: ⤷ Sign Up
Patent: 19194221
Patent: 医薬製剤 (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 66596
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16017315
Patent: FORMAS DE DOSIFICACION FARMACEUTICA. (PHARMACEUTICAL DOSAGE FORMS.)
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 170201
Patent: FORMAS DE DOSIFICACION FARMACEUTICA
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 016502540
Patent: PHARMACEUTICAL DOSAGE FORMS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 66596
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 66596
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201610227T
Patent: PHARMACEUTICAL DOSAGE FORMS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 66596
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2468610
Estimated Expiration: ⤷ Sign Up
Patent: 170029491
Patent: 제약 투여 형태 (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 86704
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 07682
Estimated Expiration: ⤷ Sign Up
Patent: 1613586
Patent: Pharmaceutical dosage forms
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 16000557
Patent: PHARMACEUTICAL DOSAGE FORMS
Estimated Expiration: ⤷ Sign Up
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 |
---|---|---|---|
Lithuania | 3166596 | ⤷ Sign Up | |
Eurasian Patent Organization | 200800488 | КОНДЕНСИРОВАННЫЕ ПРОИЗВОДНЫЕ ИМИДАЗОЛА ДЛЯ ИНГИБИРОВАНИЯ АЛЬДОСТЕРОНСИНТАЗЫ И АРОМАТАЗЫ | ⤷ Sign Up |
Brazil | 112016030243 | FORMAS DE DOSAGEM FARMACÊUTICAS, SEU PROCESSO DE PREPARAÇÃO, E USOS DE CELULOSE MICROCRISTALINA | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ISTURISA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2523731 | 2020C/520 | Belgium | ⤷ Sign Up | PRODUCT NAME: OSILODROSTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN, INCLUSIEF OSILODROSTAT DIWATERSTOFFOSFAAT; AUTHORISATION NUMBER AND DATE: EU/1/19/1407 20200113 |
2523731 | 122020000026 | Germany | ⤷ Sign Up | PRODUCT NAME: OSILODROSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 20200109 |
2523731 | 2020/020 | Ireland | ⤷ Sign Up | PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE.; REGISTRATION NO/DATE: EU/1/19/1407 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |