Generic Recorlev Availability

Last updated on Apr 10, 2025.

Recorlev is a brand name of levoketoconazole, approved by the FDA in the following formulation(s):

RECORLEV (levoketoconazole - tablet;oral)

• Manufacturer: STRONGBRIDGE
  Approval date: December 30, 2021
  Strength(s): 150MG ^[RLD]

Is there a generic version of Recorlev available?

No. There is currently no therapeutically equivalent version of Recorlev available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Recorlev. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• Methods and compositions for treating diabetes, metabolic syndrome and other conditions
  Patent 10,098,877
  Issued: October 16, 2018
  Inventor(s): Marin Per
  Assignee(s): Strongbridge Ireland Limited
  

  Pharmaceuticals compositions comprising the 2S, 4R, ketoconazole enantiomer or its pharmaceutically acceptable salts, hydrates, and solvates, that are substantially free of the 2R, 4S ketoconazole enantiomer are useful to reduce cortisol synthese and for the treatment of type 2 diabetes, hyperglycemia, obesity, insulin resistance, dyslipidemia, hyperlipidemia, hypertension, Metabolic Syndrome, and other diseases and conditions, including but not limited to Cushing's Syndrome, depression, and glaucoma.

  Patent expiration dates:

  • January 10, 2026
    
    ✓ 
    Patent 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 10,517,868
  Issued: December 31, 2019
  Inventor(s): Marin Per
  Assignee(s): Strongbridge Dublin Limited
  

  Pharmaceuticals compositions comprising the 2S, 4R, ketoconazole enantiomer or its pharmaceutically acceptable salts, hydrates, and solvates, that are substantially free of the 2R, 4S ketoconazole enantiomer are useful to reduce cortisol synthese and for the treatment of type 2 diabetes, hyperglycemia, obesity, insulin resistance, dyslipidemia, hyperlipidemia, hypertension, Metabolic Syndrome, and other diseases and conditions, including but not limited to Cushing's Syndrome, depression, and glaucoma.

  Patent expiration dates:

  • January 10, 2026
    
    ✓ 
    Patent 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 10,835,530
  Issued: November 17, 2020
  Inventor(s): Marin Per
  Assignee(s): Strongbridge Dublin Limited
  

  Pharmaceuticals compositions comprising the 2S, 4R, ketoconazole enantiomer or its pharmaceutically acceptable salts, hydrates, and solvates, that are substantially free of the 2R, 4S ketoconazole enantiomer are useful to reduce cortisol synthese and for the treatment of type 2 diabetes, hyperglycemia, obesity, insulin resistance, dyslipidemia, hyperlipidemia, hypertension, Metabolic Syndrome, and other diseases and conditions, including but not limited to Cushing's Syndrome, depression, and glaucoma.

  Patent expiration dates:

  • January 10, 2026
    
    ✓ 
    Patent 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 11,020,393
  Issued: June 1, 2021
  Inventor(s): Cohen Fredric
  Assignee(s): Strongbridge Dublin Limited
  

  Provided herein is a method of administering levoketoconazole, or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the subject is also being administered a multidrug and toxin extrusion transporter 1 (MATE1) substrate or an organic cation transporter 2 (OCT2) substrate.

  Patent expiration dates:

  • March 2, 2040
    
    ✓ 
    Patent 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 11,278,547
  Issued: March 22, 2022
  Inventor(s): Cohen Fredric
  Assignee(s): Strongbridge Dublin Limited
  

  Provided herein is a method of administering levoketoconazole, or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the subject is also being administered a multidrug and toxin extrusion transporter 1 (MATE1) substrate or an organic cation transporter 2 (OCT2) substrate.

  Patent expiration dates:

  • March 2, 2040
    
    ✓ 
    Patent 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 and compositions for treating diabetes, metabolic syndrome and other conditions
  Patent 11,478,471
  Issued: October 25, 2022
  Inventor(s): Marin; Per
  Assignee(s): Strongbridge Dublin Limited (Dublin, IE)
  

  Pharmaceuticals compositions comprising the 2S,4R, ketoconazole enantiomer or its pharmaceutically acceptable salts, hydrates, and solvates, that are substantially free of the 2R,4S ketoconazole enantiomer are useful to reduce cortisol synthesis and for the treatment of type 2 diabetes, hyperglycemia, obesity, insulin resistance, dyslipidemia, hyperlipidemia, hypertension, Metabolic Syndrome, and other diseases and conditions, including but not limited to Cushing's Syndrome, depression, and glaucoma.

  Patent expiration dates:

  • January 10, 2026
    
    ✓ 
    Patent 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 11,903,940
  Issued: February 20, 2024
  Inventor(s): Cohen; Fredric
  Assignee(s): Strongbridge Dublin Limited (Trevose, PA)
  

  Provided herein is a method of administering levoketoconazole, or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the subject is also being administered a multidrug and toxin extrusion transporter 1 (MATE1) substrate or an organic cation transporter 2 (OCT2) substrate.

  Patent expiration dates:

  • March 2, 2040
    
    ✓ 
    Patent 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
• Methods and compositions for treating diabetes, metabolic syndrome and other conditions
  Patent 9,918,984
  Issued: March 20, 2018
  Inventor(s): Marin Per
  Assignee(s): CORTENDO AB (PUBL)
  

  Pharmaceuticals compositions comprising the 2S, 4R, ketoconazole enantiomer or its pharmaceutically acceptable salts, hydrates, and solvates, that are substantially free of the 2R, 4S ketoconazole enantiomer are useful to reduce cortisol synthese and for the treatment of type 2 diabetes, hyperglycemia, obesity, insulin resistance, dyslipidemia, hyperlipidemia, hypertension, Metabolic Syndrome, and other diseases and conditions, including but not limited to Cushing's Syndrome, depression, and glaucoma.

  Patent expiration dates:

  • January 10, 2026
    
    ✓ 
    Patent use: TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN PATIENTS WITH CUSHING’S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:

  • December 30, 2026 - NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT).
  • December 30, 2028 - FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer