Details for New Drug Application (NDA): 214133

NDA 214133 describes RECORLEV, which is a drug marketed by Strongbridge and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the RECORLEV profile page.

The generic ingredient in RECORLEV is levoketoconazole. One supplier is listed for this compound. Additional details are available on the levoketoconazole profile page.

Summary for 214133

Tradename:	RECORLEV
Applicant:	Strongbridge
Ingredient:	levoketoconazole
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 214133

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.

Pharmacology for NDA: 214133

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

Suppliers and Packaging for NDA: 214133

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RECORLEV	levoketoconazole	TABLET;ORAL	214133	NDA	Xeris Pharmaceuticals, Inc.	72065-003	72065-003-01	50 TABLET in 1 BOTTLE (72065-003-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Dec 30, 2021	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 30, 2028
Regulatory Exclusivity Use:	FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
Regulatory Exclusivity Expiration:	Dec 30, 2026
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT).
Patent:	10,098,877	Patent Expiration:	Jan 10, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN PATIENTS WITH CUSHING’S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

Expired US Patents for NDA 214133

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021	10,835,530
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021	11,478,471
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021	10,517,868
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021	10,098,877

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