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Last Updated: March 29, 2024

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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 seven patents protecting this drug.

This drug has thirty-two patent family members in twenty 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:32
US Patents:7
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
Drug Prices for RECORLEV

See drug prices for RECORLEV

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RECORLEV
Generic Entry Date for RECORLEV*:
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:
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.

US Patents and Regulatory Information for RECORLEV

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

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

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 and compositions for treating diabetes, metabolic syndrome and other conditions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 and compositions for treating diabetes, metabolic syndrome and other conditions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

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

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strongbridge RECORLEV levoketoconazole TABLET;ORAL 214133-001 Dec 30, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strongbridge RECORLEV levoketoconazole TABLET;ORAL 214133-001 Dec 30, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strongbridge RECORLEV levoketoconazole TABLET;ORAL 214133-001 Dec 30, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 28005
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 94433
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1141964
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12519
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 53266
Estimated Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

Hong Kong

Patent: 18449
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4459
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 58095
Estimated Expiration: ⤷  Try a Trial

Patent: 08526830
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07008331
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0481
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 9007
Estimated Expiration: ⤷  Try a Trial

Patent: 074117
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 53266
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 53266
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 53266
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0706020
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1387910
Estimated Expiration: ⤷  Try a Trial

Patent: 070100781
Estimated Expiration: ⤷  Try a Trial

Patent: 140030327
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 77526
Estimated Expiration: ⤷  Try a Trial

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.

Country Patent Number Title Estimated Expiration
Israel 184459 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) ⤷  Try a Trial
South Korea 20140030327 METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITION ⤷  Try a Trial
Canada 3132319 PROCEDES DE TRAITEMENT D'UNE MALADIE AVEC DU LEVOKETOCONAZOLE (METHODS OF TREATING DISEASE WITH LEVOKETOCONAZOLE) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006072881 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.