Levoketoconazole - Generic Drug Details

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What are the generic sources for levoketoconazole and what is the scope of patent protection?

Levoketoconazole is the generic ingredient in one branded drug marketed by Strongbridge and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levoketoconazole has thirty-three patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for levoketoconazole

International Patents:	33
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	6
Patent Applications:	2,929
What excipients (inactive ingredients) are in levoketoconazole?	levoketoconazole excipients list
DailyMed Link:	levoketoconazole at DailyMed

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

Generic Entry Date for levoketoconazole^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE 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.

Recent Clinical Trials for levoketoconazole

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cortendo AB	Phase 1
Cortendo AB	Phase 3

See all levoketoconazole clinical trials

Pharmacology for levoketoconazole

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11A1 Inhibitors Cytochrome P450 11B1 Inhibitors Cytochrome P450 17A1 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for levoketoconazole

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 levoketoconazole

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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
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	⤷ 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 levoketoconazole

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Country	Patent Number	Title	Estimated Expiration
China	101141964	Methods and compositions for treating diabetes, metabolic syndrome and other conditions	⤷ Sign Up
New Zealand	560481	Methods and compositions for treating diabetes, metabolic syndrome and other conditions	⤷ Sign Up
Australia	2006204334	Methods and compositions for treating diabetes, metabolic syndrome and other conditions	⤷ Sign Up
South Africa	200706020	Methods and compositions for treating diabetes, metabolic syndrome and other conditions	⤷ Sign Up
Denmark	1853266		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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