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RECORLEV Drug Patent Profile

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When do Recorlev patents expire, and when can generic versions of Recorlev launch?

Recorlev is a drug marketed by Strongbridge and is included in one NDA. There are eight patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Recorlev

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RECORLEV

International Patents:	33
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	1,512
Drug Prices:	Drug price information for RECORLEV
What excipients (inactive ingredients) are in RECORLEV?	RECORLEV excipients list
DailyMed Link:	RECORLEV at DailyMed

Drug patent expirations by year for RECORLEV

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

Generic Entry Date for RECORLEV^: ⤷ 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 NDA: 214133 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 RECORLEV

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

US Patents and Regulatory Information for RECORLEV

RECORLEV is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RECORLEV is ⤷ Sign Up.

This potential generic entry date is based on FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE.
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 RECORLEV

Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN PATIENTS WITH CUSHING’S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

Methods of treating disease with levoketoconazole
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DURING LEVOKETOCONAZOLE DOSAGE TITRATION FOR THE TREATMENT OF CUSHING'S SYNDROME IN PATIENTS WHO CONCOMITANTLY USE METFORMIN, MONITORING GLYCEMIA, KIDNEY FUNCTION AND VITAMIN B-12 AND ADJUSTING DOSAGE OF METFORMIN AS NEEDED

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN PATIENTS WITH CUSHING’S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DURING LEVOKETOCONAZOLE DOSAGE TITRATION FOR THE TREATMENT OF CUSHING'S SYNDROME IN PATIENTS WHO CONCOMITANTLY USE AN OCT2 SUBSTRATE, MONITORING THE SUBJECT FOR A DOSE LIMITING EVENT AND ADJUSTING THE DOSAGE OF THE OCT2 SUBSTRATE AS NEEDED

FDA Regulatory Exclusivity protecting RECORLEV

FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM 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
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
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 RECORLEV

When does loss-of-exclusivity occur for RECORLEV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06204334
Patent: Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Estimated Expiration: ⤷ Sign Up

Austria

Patent: 28005
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 94433
Patent: PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DU DIABETE, DU SYNDROME METABOLIQUE ET D'AUTRES CONDITIONS (METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 1141964
Patent: Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 12519
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 53266
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 53266
Patent: 2S,4R KETOCONAZOLE POUR LE TRAITEMENT DU DIABETE, DU SYNDROME METABOLIQUE ET D'AUTRES CONDITIONS (2S,4R KETOCONAZOLE FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 18449
Patent: METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 4459
Patent: תכשירי רוקחות המכילים אנאנטיאומר של s2, r4 קטוקונאזול לטיפול במחלות הנובעות מהגברת קורטיזול (Use of a 2s, 4r ketoconazole enantiomer for the preparation of medicaments for the treatment of elevated cortisol-mediated diseases)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 58095
Estimated Expiration: ⤷ Sign Up

Patent: 08526830
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 07008331
Patent: METODOS Y COMPOSICIONES PARA EL TRATAMIENTO DE DIABETES, SINDROME METABOLICO Y OTRAS CONDICIONES. (METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 0481
Patent: Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Estimated Expiration: ⤷ Sign Up

Norway

Patent: 9007
Estimated Expiration: ⤷ Sign Up

Patent: 074117
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 53266
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 53266
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 53266
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0706020
Patent: Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1387910
Estimated Expiration: ⤷ Sign Up

Patent: 070100781
Patent: METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS
Estimated Expiration: ⤷ Sign Up

Patent: 140030327
Patent: METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITION
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 77526
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 RECORLEV around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1118449	METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS	⤷ Sign Up
Brazil	112021017561	Método de tratamento de uma doença	⤷ Sign Up
New Zealand	560481	Methods and compositions for treating diabetes, metabolic syndrome and other conditions	⤷ Sign Up
Spain	2377526		⤷ Sign Up
Japan	2008526830		⤷ Sign Up
Japan	5358095		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

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Questions you can ask:

Summary for RECORLEV

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

Pharmacology for RECORLEV

Patents protecting RECORLEV

FDA Regulatory Exclusivity protecting RECORLEV

When does loss-of-exclusivity occur for RECORLEV?

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