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Last Updated: March 19, 2024

Mifepristone - Generic Drug Details


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What are the generic drug sources for mifepristone and what is the scope of freedom to operate?

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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Recent Clinical Trials for mifepristone

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

SponsorPhase
Planned Parenthood League of MassachusettsPhase 3
Women's Hospital School Of Medicine Zhejiang UniversityN/A
Corcept TherapeuticsPhase 4

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc MIFEPRISTONE mifepristone TABLET;ORAL 211436-001 Aug 3, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for mifepristone

Country Patent Number Title Estimated Expiration
Japan 7218294 ⤷  Try a Trial
Mexico 2018008849 DIAGNOSTICO DIFERENCIAL DE SINDROME DE CUSHING ECTOPICO. (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME.) ⤷  Try a Trial
Israel 257439 שיטות לאבחון מבדיל של סינדרום קושינג תלוי הורמון אדרנוקורטיקוטרופי (Method for differentially diagnosing acth-dependent cushing's syndrome) ⤷  Try a Trial
Hong Kong 1255714 鑑別診斷ACTH依賴性庫欣綜合症的方法 (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME) ⤷  Try a Trial
Japan 2018529941 ACTH依存性クッシング症候群を鑑別診断する方法 ⤷  Try a Trial
South Korea 20190122239 글루코코르티코이드 수용체 조정제 및 CYP3A 억제제의 병용 투여 ⤷  Try a Trial
Japan 6765443 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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