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
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 |
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.
Pharmacology for RECORLEV
Anatomical Therapeutic Chemical (ATC) Classes for RECORLEV
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 |