Recorlev is a drug owned by Strongbridge Dublin Ltd. It is protected by 9 US drug patents filed from 2022 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 02, 2040. Details of Recorlev's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12377096 | NA |
Mar, 2040
(14 years from now) | Active |
| US11278547 | Methods of treating disease with levoketoconazole |
Mar, 2040
(14 years from now) | Active |
| US11903940 | Methods of treating disease with levoketoconazole |
Mar, 2040
(14 years from now) | Active |
| US11020393 | Methods of treating disease with levoketoconazole |
Mar, 2040
(14 years from now) | Active |
| US9918984 | Methods and compositions for treating diabetes, metabolic syndrome and other conditions |
May, 2028
(2 years from now) | Active |
| US10835530 | Methods and compositions for treating diabetes, metabolic syndrome and other conditions |
Jan, 2026
(2 months from now) | Active |
| US10517868 | Methods and compositions for treating diabetes, metabolic syndrome and other conditions |
Jan, 2026
(2 months from now) | Active |
| US11478471 | Methods and compositions for treating diabetes, metabolic syndrome and other conditions |
Jan, 2026
(2 months from now) | Active |
| US10098877 | Methods and compositions for treating diabetes, metabolic syndrome and other conditions |
Jan, 2026
(2 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Recorlev's patents.
Latest Legal Activities on Recorlev's Patents
Given below is the list of recent legal activities going on the following patents of Recorlev.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 06 May, 2024 | US10835530 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9918984 |
| Patent Issue Date Used in PTA Calculation
Critical | 20 Feb, 2024 | US11903940 |
| Recordation of Patent eGrant | 20 Feb, 2024 | US11903940 |
| Recordation of Patent Grant Mailed
Critical | 20 Feb, 2024 | US11903940 |
| Mail Patent eGrant Notification | 20 Feb, 2024 | US11903940 |
| Patent eGrant Notification | 20 Feb, 2024 | US11903940 |
| Email Notification
Critical | 20 Feb, 2024 | US11903940 |
| Email Notification
Critical | 01 Feb, 2024 | US11903940 |
| Issue Notification Mailed
Critical | 31 Jan, 2024 | US11903940 |
FDA has granted several exclusivities to Recorlev. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Recorlev, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Recorlev.
Exclusivity Information
Recorlev holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Recorlev's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| NCE*(NCE*) | Dec 30, 2026 |
| Orphan Drug Exclusivity(ODE-385) | Dec 30, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Recorlev is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Recorlev's family patents as well as insights into
ongoing legal events
on those patents.
Recorlev's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Recorlev's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 02, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Recorlev Generics:
There are no approved generic versions for Recorlev as of now.
About Recorlev
Recorlev is a drug owned by Strongbridge Dublin Ltd. It is used for treating Cushing's syndrome in patients with endogenous hypercortisolemia, when surgery is not an option or has not been curative. Recorlev uses Levoketoconazole as an active ingredient. Recorlev was launched by Strongbridge in 2021.
Approval Date:
Recorlev was approved by FDA for market use on 30 December, 2021.
Active Ingredient:
Recorlev uses Levoketoconazole as the active ingredient. Check out other Drugs and Companies using Levoketoconazole ingredient
Treatment:
Recorlev is used for treating Cushing's syndrome in patients with endogenous hypercortisolemia, when surgery is not an option or has not been curative.
Dosage:
Recorlev is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |