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Last Updated: August 11, 2022

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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in twelve countries.

The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. One supplier is 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
Drug patent expirations by year for KORLYM
Recent Clinical Trials for KORLYM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Charles Drew University of Medicine and SciencePhase 2
Johns Hopkins UniversityN/A
National Institute on Alcohol Abuse and Alcoholism (NIAAA)N/A

See all KORLYM clinical trials

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 sixteen US patents.

Patents protecting KORLYM

Method for differentially diagnosing ACTH-dependent cushing's syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Treatment and differential diagnosis of Cushing's disease and ectopic Cushing's syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Optimizing mifepristone levels for Cushing's patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Optimizing mifepristone levels for cushing'S patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Method for differentially diagnosing ACTH-dependent Cushing's syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Optimizing mifepristone absorption
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Optimizing mifepristone levels for cushing's patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Optimizing mifepristone absorption
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Method for differentially diagnosing ACTH-dependent Cushing's syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CUSHING'S SYNDROME

Optimizing mifepristone levels for cushing's patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Mexico 2018008849 DIAGNOSTICO DIFERENCIAL DE SINDROME DE CUSHING ECTOPICO. (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME.) See Plans and Pricing
South Korea 20180052120 ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법 See Plans and Pricing
Spain 2865334 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
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Medtronic
Harvard Business School
Moodys

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.