Korlym is a drug owned by Corcept Therapeutics Inc. It is protected by 18 US drug patents filed from 2015 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 22, 2038. Details of Korlym'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). | |||
| US10314850 | Use of ACTH in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients |
Aug, 2038
(13 years from now) | Active |
| US10780097 | Use of cortisol in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients |
Aug, 2038
(13 years from now) | Active |
| US10231983 | Use of ACTH in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients |
Aug, 2038
(13 years from now) | Active |
| US10195214 | Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors |
Jun, 2037
(12 years from now) | Active |
| US11969435 | Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors |
Jun, 2037
(12 years from now) | Active |
| US10842800 | Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors |
Jun, 2037
(12 years from now) | Active |
| US12097210 | Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors |
Jun, 2037
(12 years from now) | Active |
| US10151763 | Treatment and differential diagnosis of Cushing's disease and ectopic Cushing's syndrome |
Jan, 2037
(12 years from now) | Active |
| US9829495 | Method for differentially diagnosing ACTH-dependent Cushing's syndrome |
Aug, 2036
(11 years from now) | Active |
| US10495650 | Method for differentially diagnosing ACTH-dependent Cushing's syndrome |
Aug, 2036
(11 years from now) | Active |
| US10006924 | Method for differentially diagnosing ACTH-dependent cushing's syndrome |
Aug, 2036
(11 years from now) | Active |
| US10660904 | Optimizing mifepristone levels for cushing's patients |
Apr, 2036
(11 years from now) | Active |
| US10166242 | Optimizing mifepristone levels for Cushing's patients |
Apr, 2036
(11 years from now) | Active |
| US10166243 | Optimizing mifepristone levels for cushing'S patients |
Apr, 2036
(11 years from now) | Active |
| US9943526 | Optimizing mifepristone levels for cushing's patients |
Apr, 2036
(11 years from now) | Active |
| US10500216 | Optimizing mifepristone absorption |
Mar, 2033
(8 years from now) | Active |
| US10842801 | Optimizing mifepristone absorption |
Nov, 2032
(7 years from now) | Active |
| US8921348 | Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists |
Aug, 2028
(3 years 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 Korlym's patents.
Latest Legal Activities on Korlym's Patents
Given below is the list of recent legal activities going on the following patents of Korlym.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 May, 2024 | US10842800 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 May, 2024 | US10842801 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 06 Mar, 2024 | US10780097 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 Nov, 2023 | US10660904 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 24 May, 2023 | US10500216 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 17 May, 2023 | US10495650 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 23 Nov, 2022 | US10314850 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 07 Sep, 2022 | US10231983 |
| Review Certificate Mailed | 03 Aug, 2022 | US10195214 |
| Review Certificate | 25 Jul, 2022 | US10195214 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Korlym and ongoing litigations to help you estimate the early arrival of Korlym generic.
Korlym's Litigations
Korlym been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 02, 2018, against patent number US8921348. The petitioner Neptune Generics LLC, challenged the validity of this patent, with Corcept Therapeutics Inc. as the respondent. Click below to track the latest information on how companies are challenging Korlym's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10195214 | May, 2019 |
FWD Entered
(18 Nov, 2020) | Corcept Therapeutics, Inc. | Teva Pharmaceuticals USA, Inc. |
| US8921348 | August, 2018 |
FWD Entered
(10 Feb, 2020) | Corcept Therapeutics Inc. | Neptune Generics LLC |
FDA has granted some exclusivities to Korlym. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Korlym, 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 Korlym.
Exclusivity Information
Korlym holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Korlym's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 17, 2015 |
| Orphan Drug Exclusivity(ODE) | Feb 17, 2019 |
| Orphan Drug Exclusivity(ODE-22) | Feb 17, 2019 |
US patents provide insights into the exclusivity only within the United States, but Korlym 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 Korlym's family patents as well as insights into ongoing legal events on those patents.
Korlym's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Korlym's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 22, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Korlym Generic API suppliers:
Mifepristone is the generic name for the brand Korlym. 2 different companies have already filed for the generic of Korlym, with Genbiopro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Korlym's generic
How can I launch a generic of Korlym before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Korlym's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Korlym's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Korlym -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg | 15 Dec, 2017 | 1 | 03 Aug, 2020 | 15 Aug, 2036 | Eligible |
About Korlym
Korlym is a drug owned by Corcept Therapeutics Inc. It is used for managing symptoms associated with Cushing's syndrome. Korlym uses Mifepristone as an active ingredient. Korlym was launched by Corcept Therap in 2012.
Approval Date:
Korlym was approved by FDA for market use on 17 February, 2012.
Active Ingredient:
Korlym uses Mifepristone as the active ingredient. Check out other Drugs and Companies using Mifepristone ingredient
Treatment:
Korlym is used for managing symptoms associated with Cushing's syndrome.
Dosage:
Korlym is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG | TABLET | Prescription | ORAL |