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Generic Korlym Availability

Last updated on May 11, 2021.

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

KORLYM (mifepristone - tablet;oral)

  • Manufacturer: CORCEPT THERAP
    Approval date: February 17, 2012
    Strength(s): 300MG [RLD] [AB]

Has a generic version of Korlym been approved?

A generic version of Korlym has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Korlym and have been approved by the FDA:

mifepristone tablet;oral

  • Manufacturer: TEVA PHARMS USA INC
    Approval date: August 3, 2020
    Strength(s): 300MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Korlym. 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.

  • Method for differentially diagnosing ACTH-dependent cushing's syndrome
    Patent 10,006,924
    Issued: June 26, 2018
    Assignee(s): Corcept Therapeutics, Inc.

    This invention provides for an improved method for differentially diagnosing ACTH-dependent Cushing's syndrome. Current practice for differentially diagnosing ectopic ACTH syndrome and Cushing's Disease measures relative ACTH concentrations from the inferior petrosal venous sinus compared to fluid obtained from a periphery venous sample. This is performed before and after administration of exogenous corticotropin releasing factor, or after administration of metyrapone. This invention uses glucocorticoid receptor antagonists to induce release of endogenous CRH which stimulates ACTH to increase in patients with ectopic ACTH syndrome but not in those with Cushing's Disease.

    Patent expiration dates:

    • August 12, 2036
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Treatment and differential diagnosis of Cushing's disease and ectopic Cushing's syndrome
    Patent 10,151,763
    Issued: December 11, 2018
    Assignee(s): Corcept Therapeutics, Inc.

    Improved methods and systems for diagnosing and for treating Cushing's syndrome and Cushing's Disease are provided herein, including methods and systems for concurrently treating Cushing's syndrome and differentially diagnosing Cushing's Disease from Ectopic Cushing's Syndrome in a patient with an established diagnosis of ACTH-dependent Cushing's syndrome. Treatment methods can use glucocorticoid receptor antagonists (GRAs), which differentially affect the ratio of cortisol to ACTH levels in patients having Cushing's Disease versus patients having Ectopic Cushing's Syndrome. Methods for concurrently treating and differentially diagnosing Cushing's Disease from Ectopic Cushing's Syndrome include obtaining baseline cortisol and ACTH levels of a patient, treating the patient with a GRA according to a protocol that would typically substantially elevate cortisol levels, obtaining post-treatment cortisol and ACTH levels of the patient, determining a differential relationship between baseline cortisol and ACTH levels and post-treatment cortisol and ACTH levels and providing a positive diagnosis based on the differential relationship.

    Patent expiration dates:

    • January 18, 2037
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Optimizing mifepristone levels for Cushing's patients
    Patent 10,166,242
    Issued: January 1, 2019
    Assignee(s): Corcept Therapeutics, Inc.

    The present invention provides a method for optimizing levels of mifepristone in a patient suffering from Cushing's syndrome. The method comprises the steps of treating the patient with seven or more daily doses of mifepristone over a period of seven or more days; testing the serum levels of the patient to determine whether the blood levels of mifepristone are greater than 1631 ng/mL; and adjusting the daily dose of the patient to achieve mifepristone blood levels greater than 1631 ng/mL.

    Patent expiration dates:

    • April 20, 2036
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Optimizing mifepristone levels for cushing'S patients
    Patent 10,166,243
    Issued: January 1, 2019
    Assignee(s): Corcept Therapeutics, Inc.

    The present invention provides a method for optimizing levels of mifepristone in a patient suffering from Cushing's syndrome. The method comprises the steps of treating the patient with seven or more daily doses of mifepristone over a period of seven or more days; testing the serum levels of the patient to determine whether the blood levels of mifepristone are greater than 1631 ng/mL; and adjusting the daily dose of the patient to achieve mifepristone blood levels greater than 1631 ng/mL.

    Patent expiration dates:

    • April 20, 2036
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
    Patent 10,195,214
    Issued: February 5, 2019
    Assignee(s): Corcept Therapeutics, Inc.

    Applicant provides methods of treating diseases including Cushing's syndrome and hormone-sensitive cancers by concomitant administration of a glucocorticoid receptor antagonist (GRA) and steroidogenesis inhibitors, and by concomitant administration of a GRA and CYP3A inhibitors. Applicant provides methods of treating diseases including Cushing's syndrome and hormone-sensitive cancers by concomitant administration of mifepristone and ketoconazole. Subjects treated with CYP3A inhibitors or steroidogenesis inhibitors may suffer from toxicity or other serious adverse reactions; concomitant administration of other drugs would be expected to increase the risk of such toxicity and adverse reactions. Applicant has surprisingly found that GRAs may be administered to subjects receiving CYP3A inhibitors or steroidogenesis inhibitors such as ketoconazole without increasing risk adverse reactions; for example, Applicant has found that mifepristone may be concomitantly administered with ketoconazole (a CYP3A inhibitor and a steroidogenesis inhibitor), providing safe concomitant administration of the GRA and ketoconazole. In embodiments, the GRA dose may be reduced.

    Patent expiration dates:

    • June 19, 2037
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Use of ACTH in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients
    Patent 10,231,983
    Issued: March 19, 2019
    Assignee(s): Corcept Therapeutics, Inc.

    This invention provides new methods for a) identifying Cushing's Syndrome patients at high risk of developing hypokalemia during glucocorticoid receptor modulator (GRM) treatment, and b) for prophylactically treating such patients to prevent, or reduce the severity of, hypokalemia. Patients at such high risk may be identified prior to their developing hypokalemia. Such a patient may be an adult patient with endogenous Cushing's Syndrome having type 2 diabetes mellitus or glucose intolerance to control hyperglycemia secondary to hypercortisolism. Patients may be identified by an above-threshold level of ACTH or cortisol in a patient sample taken post-GRM administration or pre-GRM administration, respectively. Upon identifying such a patient prior to the development of low potassium, the present methods provide for prophylactically treating the patient by administration of one or more hypokalemia treatments concurrently with an increased dose of GRM or with an initial dose of GRM to prevent hypokalemia.

    Patent expiration dates:

    • August 22, 2038
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Use of ACTH in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients
    Patent 10,314,850
    Issued: June 11, 2019
    Assignee(s): Corcept Therapeutics, Inc.

    This invention provides new methods for a) identifying Cushing's Syndrome patients at high risk of developing hypokalemia during glucocorticoid receptor modulator (GRM) treatment, and b) for prophylactically treating such patients to prevent, or reduce the severity of, hypokalemia. Patients at such high risk may be identified prior to their developing hypokalemia. Such a patient may be an adult patient with endogenous Cushing's Syndrome having type 2 diabetes mellitus or glucose intolerance to control hyperglycemia secondary to hypercortisolism. Patients may be identified by an above-threshold level of ACTH or cortisol in a patient sample taken post-GRM administration or pre-GRM administration, respectively. Upon identifying such a patient prior to the development of low potassium, the present methods provide for prophylactically treating the patient by administration of one or more hypokalemia treatments concurrently with an increased dose of GRM or with an initial dose of GRM to prevent hypokalemia.

    Patent expiration dates:

    • August 22, 2038
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Patent 10,495,650

    Patent expiration dates:

    • August 12, 2036
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Patent 10,500,216

    Patent expiration dates:

    • March 5, 2033
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Patent 10,660,904

    Patent expiration dates:

    • April 20, 2036
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Patent 10,780,097

    Patent expiration dates:

    • August 22, 2038
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Patent 10,842,800

    Patent expiration dates:

    • June 19, 2037
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Patent 10,842,801

    Patent expiration dates:

    • November 15, 2032
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists
    Patent 8,921,348
    Issued: December 30, 2014
    Assignee(s): Corcept Therapeutics, Inc.

    The present invention provides a method for optimizing levels of mifepristone in a patient suffering from a mental disorder amenable to treatment by mifepristone. The method comprises the steps of treating the patient with seven or more daily doses of mifepristone over a period of seven or more days; testing the serum levels of the patient to determine whether the blood levels of mifepristone are greater than 1300 ng/mL; and adjusting the daily dose of the patient to achieve mifepristone blood levels greater than 1300 ng/mL.

    Patent expiration dates:

    • August 27, 2028
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Method for differentially diagnosing ACTH-dependent Cushing's syndrome
    Patent 9,829,495
    Issued: November 28, 2017
    Assignee(s): Corcept Therapeutics, Inc.

    This invention provides for an improved method for differentially diagnosing ACTH-dependent Cushing's syndrome. Current practice for differentially diagnosing ectopic ACTH syndrome and Cushing's Disease measures relative ACTH concentrations from the inferior petrosal venous sinus compared to fluid obtained from a periphery venous sample. This is performed before and after administration of exogenous corticotropin releasing factor, or after administration of metyrapone. This invention uses glucocorticoid receptor antagonists to induce release of endogenous CRH which stimulates ACTH to increase in patients with ectopic ACTH syndrome but not in those with Cushing's Disease.

    Patent expiration dates:

    • August 15, 2036
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME
  • Optimizing mifepristone levels for cushing's patients
    Patent 9,943,526
    Issued: April 17, 2018
    Assignee(s): Corcept Therapeutics, Inc.

    The present invention provides a method for optimizing levels of mifepristone in a patient suffering from Cushing's syndrome. The method comprises the steps of treating the patient with seven or more daily doses of mifepristone over a period of seven or more days; testing the serum levels of the patient to determine whether the blood levels of mifepristone are greater than 1631 ng/mL; and adjusting the daily dose of the patient to achieve mifepristone blood levels greater than 1631 ng/mL.

    Patent expiration dates:

    • April 20, 2036
      ✓ 
      Patent use: TREATING CUSHING'S SYNDROME

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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