KORLYM Drug Patent Profile
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Which patents cover Korlym, and what generic alternatives are available?
Korlym is a drug marketed by Corcept Therap and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-nine patent family members in twelve countries.
The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Korlym
A generic version of KORLYM was approved as mifepristone by GENBIOPRO on April 11th, 2019.
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Summary for KORLYM
| International Patents: | 39 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 11 |
| Patent Applications: | 4,965 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KORLYM |
| What excipients (inactive ingredients) are in KORLYM? | KORLYM excipients list |
| DailyMed Link: | KORLYM at DailyMed |
Recent Clinical Trials for KORLYM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Corcept Therapeutics | Phase 4 |
| Charles Drew University of Medicine and Science | Phase 2 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | N/A |
Pharmacology for KORLYM
| Drug Class | Progestin Antagonist |
| Mechanism of Action | Progestational Hormone Receptor Antagonists |
Paragraph IV (Patent) Challenges for KORLYM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KORLYM | Tablets | mifepristone | 300 mg | 202107 | 1 | 2017-12-15 |
US Patents and Regulatory Information for KORLYM
KORLYM is protected by eighteen US patents.
Patents protecting KORLYM
Method for differentially diagnosing ACTH-dependent cushing's syndrome
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Patented Use: TREATING CUSHING'S SYNDROME
Treatment and differential diagnosis of Cushing's disease and ectopic Cushing's syndrome
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Patented Use: TREATING CUSHING'S SYNDROME
Optimizing mifepristone levels for Cushing's patients
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Patented Use: TREATING CUSHING'S SYNDROME
Optimizing mifepristone levels for cushing'S patients
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Patented Use: TREATING CUSHING'S SYNDROME
Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
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Patented 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
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Patented 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
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Method for differentially diagnosing ACTH-dependent Cushing's syndrome
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Optimizing mifepristone absorption
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Optimizing mifepristone levels for cushing's patients
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Use of cortisol in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Optimizing mifepristone absorption
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists
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Patented Use: TREATING CUSHING'S SYNDROME
Method for differentially diagnosing ACTH-dependent Cushing's syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
Optimizing mifepristone levels for cushing's patients
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CUSHING'S SYNDROME
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Corcept Therap | KORLYM | mifepristone | TABLET;ORAL | 202107-001 | Feb 17, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Corcept Therap | KORLYM | mifepristone | TABLET;ORAL | 202107-001 | Feb 17, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Corcept Therap | KORLYM | mifepristone | TABLET;ORAL | 202107-001 | Feb 17, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Corcept Therap | KORLYM | mifepristone | TABLET;ORAL | 202107-001 | Feb 17, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Corcept Therap | KORLYM | mifepristone | TABLET;ORAL | 202107-001 | Feb 17, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for KORLYM
See the table below for patents covering KORLYM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 269009 | טיפול משולב בו זמנית עם מודולטורים של קולטני גלוקוקורטיקואידים ומעכבי cyp3a (Concomitant administration of glucocorticoid receptor modulators and cyp3a inhibitors) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2018160775 | ⤷ Sign Up | |
| Japan | 2019503495 | 異所性クッシング症候群の鑑別診断 | ⤷ Sign Up |
| Japan | 2023052618 | 糖質コルチコイド受容体モジュレータおよびＣＹＰ３Ａインヒビタの併用投与 | ⤷ Sign Up |
| South Korea | 20180052120 | ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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