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Last Updated: January 27, 2023

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-four patent family members in twelve countries.

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

Recent Clinical Trials for mifepristone

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

SponsorPhase
KK Women's and Children's HospitalPhase 4
Washington University School of MedicinePhase 4
Calcutta National Medical College and HospitalPhase 3

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 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
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

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

International Patents for mifepristone

Country Patent Number Title Estimated Expiration
South Korea 20180096803 이소성 쿠싱 증후군의 감별 진단 See Plans and Pricing
China 110352058 相伴给予糖皮质激素受体调节剂和CYP3A抑制剂 (CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A INHIBITORS) See Plans and Pricing
Japan 6768789 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2020009824 See Plans and Pricing
Japan 2019503495 異所性クッシング症候群の鑑別診断 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Express Scripts
Baxter
Merck
AstraZeneca

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.