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Last Updated: October 16, 2024

Mifepristone - Generic Drug Details


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What are the generic drug sources for mifepristone and what is the scope of patent protection?

Mifepristone is the generic ingredient in three branded drugs marketed by Corcept Therap, Danco Labs Llc, Genbiopro, and Teva Pharms Usa Inc, and is included in four NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mifepristone has thirty-eight patent family members in twelve countries.

There are six drug master file entries for mifepristone. Three suppliers are listed for this compound.

Summary for mifepristone
Recent Clinical Trials for mifepristone

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

SponsorPhase
Astellas Pharma US, Inc.Phase 2
Memorial Sloan Kettering Cancer CenterPhase 2
Breast Cancer Research FoundationPhase 2

See all mifepristone clinical trials

Pharmacology for mifepristone
Paragraph IV (Patent) Challenges for MIFEPRISTONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KORLYM Tablets mifepristone 300 mg 202107 1 2017-12-15

US Patents and Regulatory Information for mifepristone

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
Genbiopro MIFEPRISTONE mifepristone TABLET;ORAL 091178-001 Apr 11, 2019 AB RX No No ⤷  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

Expired US Patents for mifepristone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Sign Up ⤷  Sign Up
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Sign Up ⤷  Sign Up
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for mifepristone

Country Patent Number Title Estimated Expiration
South Korea 20180052120 ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법 ⤷  Sign Up
Canada 2994422 PROCEDE PERMETTANT D'ETABLIR UN DIAGNOSTIC DIFFERENTIEL DU SYNDROME DE CUSHING EN FONCTION DE L'HORMONE ADRENOCORTICOTROPE (ACTH) (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME) ⤷  Sign Up
European Patent Office 3405101 DIAGNOSTIC DIFFÉRENTIEL DU SYNDROME DE CUSHING ECTOPIQUE (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME) ⤷  Sign Up
Japan 7516586 ⤷  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
>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.