Recorlev Patent Expiration

Recorlev is a drug owned by Strongbridge Dublin Ltd. It is protected by 8 US drug patents filed from 2022 to 2024 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9918984 Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Jan, 2026

(1 year, 5 months from now)

Active
US11478471 Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Jan, 2026

(1 year, 5 months from now)

Active
US10835530 Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Jan, 2026

(1 year, 5 months from now)

Active
US10517868 Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Jan, 2026

(1 year, 5 months from now)

Active
US10098877 Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Jan, 2026

(1 year, 5 months from now)

Active
US11020393 Methods of treating disease with levoketoconazole
Mar, 2040

(15 years from now)

Active
US11903940 Methods of treating disease with levoketoconazole
Mar, 2040

(15 years from now)

Active
US11278547 Methods of treating disease with levoketoconazole
Mar, 2040

(15 years from now)

Active


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 1 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
Orphan Drug Exclusivity(ODE-385) Dec 30, 2028

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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

Recorlev has patent protection in a total of 21 countries. It's US patent count contributes only to 31.7% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Recorlev.

Family Patents

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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.

Market Authorisation 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