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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

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, and Genbiopro, and is included in three NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mifepristone has twenty-eight patent family members in eleven countries.

There are six drug master file entries for mifepristone. One supplier is listed for this compound.

Recent Clinical Trials for mifepristone

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

SponsorPhase
Queen Mary Hospital, Hong KongPhase 3
Center for Information and Counseling on Reproductive Health - TanadgomaPhase 4
Grand Challenges CanadaPhase 4

See all mifepristone clinical trials

Pharmacology for mifepristone
Paragraph IV (Patent) Challenges for MIFEPRISTONE
Tradename Dosage Ingredient NDA Submissiondate
KORLYM TABLET;ORAL mifepristone 202107 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 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genbiopro MIFEPRISTONE mifepristone TABLET;ORAL 091178-001 Apr 11, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 RX Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000   Start Trial   Start Trial
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Baxter
Medtronic
McKesson
AstraZeneca

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