OSILODROSTAT PHOSPHATE - Generic Drug Details

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What are the generic drug sources for osilodrostat phosphate and what is the scope of freedom to operate?

Osilodrostat phosphate is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Osilodrostat phosphate has one hundred and thirty-five patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for OSILODROSTAT PHOSPHATE

International Patents:	135
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	7
DailyMed Link:	OSILODROSTAT PHOSPHATE at DailyMed

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

Generic Entry Date for OSILODROSTAT PHOSPHATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 OSILODROSTAT PHOSPHATE

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

Anatomical Therapeutic Chemical (ATC) Classes for OSILODROSTAT PHOSPHATE

H02CA	Anticorticosteroids
H02C	ANTIADRENAL PREPARATIONS
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for OSILODROSTAT PHOSPHATE

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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	212801-002	Mar 6, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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 OSILODROSTAT PHOSPHATE

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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 OSILODROSTAT PHOSPHATE

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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

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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.

Summary for OSILODROSTAT PHOSPHATE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OSILODROSTAT PHOSPHATE

Pharmacology for OSILODROSTAT PHOSPHATE

Anatomical Therapeutic Chemical (ATC) Classes for OSILODROSTAT PHOSPHATE

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

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