Osilodrostat phosphate - Generic Drug Details

What are the generic 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

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

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
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No			Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No

International Patents for osilodrostat phosphate

Country	Patent Number	Title	Estimated Expiration
Peru	20070517	DERIVADOS DE IMIDAZOL COMO AGENTES INHIBIDORES DE LA SINTASA DE ALDOSTERONA Y AROMATASA
Spain	2707596
Russian Federation	2598708	ПРИМЕНЕНИЕ АГЕНТА, ОБЛАДАЮЩЕГО МОДИФИЦИРУЮЩИМИ СВОЙСТВАМИ В ОТНОШЕНИИ ГОРМОНОВ НАДПОЧЕЧНИКОВ (APPLICATION OF AGENT WITH MODIFYING PROPERTIES IN RELATION TO HORMONES OF ADRENAL GLANDS)
Chile	2017000026	Formas de dosificación farmacéutica
European Patent Office	2256118	Dérivés d'imidazole condensé pour l'inhibition d'aromatase et pour la traitement des maladies dependents d'aldosterone (Condensed imidazolo derivatives for the inhibition of aromatase and the treatment of aldosterone related diseases)

Supplementary Protection Certificates for osilodrostat phosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	24/2020	Austria		PRODUCT NAME: OSILODROSTAT ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 (MITTEILUNG) 20200113
2523731	2090024-7	Sweden		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; REG. NO/DATE: EU/1/19/1407 20200113
2523731	2020C/520	Belgium		PRODUCT NAME: OSILODROSTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN, INCLUSIEF OSILODROSTAT DIWATERSTOFFOSFAAT; AUTHORISATION NUMBER AND DATE: EU/1/19/1407 20200113
2523731	PA2020512	Lithuania		PRODUCT NAME: OSILODROSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT OSILODROSTATO DIHIDROFOSFATA; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731	2020/020	Ireland		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE.; REGISTRATION NO/DATE: EU/1/19/1407 20200113