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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

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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

Drug patent expirations by year for ISTURISA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ISTURISA

Generic Entry Date for ISTURISA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 212801 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

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11B1 Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors

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

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Glossary

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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.

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Country	Patent Number	Title	Estimated Expiration
Canada	2619660	DERIVES IMIDAZOLO CONDENSES UTILISES POUR INHIBER L'ALDOSTERONE SYNTHASE ET L'AROMATASE (CONDENSED IMIDAZOLO DERIVATIVES FOR THE INHIBITION OF ALDOSTERONE SYNTHASE AND AROMATASE)	⤷ Sign Up
Spain	2417498		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011088188		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ISTURISA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	C20200013 00309	Estonia	⤷ Sign Up	PRODUCT NAME: OSILODROSTAAT;REG NO/DATE: EU/1/19/1407 13.01.2020
2523731	CR 2020 00025	Denmark	⤷ Sign Up	PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731	SPC/GB20/034	United Kingdom	⤷ Sign Up	PRODUCT NAME: OSILODROSTAT, OR OSILODROSTAT PHOSPHATE; REGISTERED: UK EU/1/19/1407/001(NI) 20200113; UK EU/1/19/1407/002(NI) 20200113; UK EU/1/19/1407/003(NI) 20200113; UK PLGB 15266/0029-0001 20200113; UK PLGB 15266/0030-0001 20200113; UK PLGB 15266/0031-0001 20200113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

AI Research Assistant

Questions you can ask:

Summary for ISTURISA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ISTURISA

Pharmacology for ISTURISA

Patents protecting ISTURISA

FDA Regulatory Exclusivity protecting ISTURISA

When does loss-of-exclusivity occur for ISTURISA?

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ISTURISA