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Last Updated: April 24, 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 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.

Summary for MIFEPRISTONE

International Patents:	37
US Patents:	16
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	195
Patent Applications:	8,221
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIFEPRISTONE
What excipients (inactive ingredients) are in MIFEPRISTONE?	MIFEPRISTONE excipients list
DailyMed Link:	MIFEPRISTONE at DailyMed

Recent Clinical Trials for MIFEPRISTONE

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

Sponsor	Phase
Women's Hospital School Of Medicine Zhejiang University	N/A
Planned Parenthood League of Massachusetts	Phase 3
Corcept Therapeutics	Phase 4

See all MIFEPRISTONE clinical trials

Pharmacology for MIFEPRISTONE

Drug Class	Progestin Antagonist
Mechanism of Action	Progestational Hormone Receptor Antagonists

Medical Subject Heading (MeSH) Categories for MIFEPRISTONE

Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents

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

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Glossary

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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
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
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000	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
>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

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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

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Country	Patent Number	Title	Estimated Expiration
Australia	2018229355	Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors	⤷ Try a Trial
South Korea	102197526		⤷ Try a Trial
South Korea	20180052120	ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법	⤷ Try a Trial
Spain	2865334		⤷ Try a Trial
South Korea	20190122239	글루코코르티코이드 수용체 조정제 및 CYP3A 억제제의 병용 투여	⤷ Try a Trial
Mexico	2018001803	METODO PARA DISGNOSTICAR DE MANERA DIFERENCIAL EL SINDROME DE CUSHING DEPENDIENTE DE LA CORTICOTROPINA. (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME.)	⤷ Try a Trial
Mexico	2018008849	DIAGNOSTICO DIFERENCIAL DE SINDROME DE CUSHING ECTOPICO. (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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