MIFEPRISTONE - Generic Drug Details

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What are the generic 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 eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mifepristone has thirty-nine 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

International Patents:	39
US Patents:	18
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	196
Patent Applications:	7,047
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
Astellas Pharma US, Inc.	Phase 2
Memorial Sloan Kettering Cancer Center	Phase 2
Breast Cancer Research Foundation	Phase 2

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

Anatomical Therapeutic Chemical (ATC) Classes for MIFEPRISTONE

G03XB	Progesterone receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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	⤷ 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
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

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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	⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Israel	269009	טיפול משולב בו זמנית עם מודולטורים של קולטני גלוקוקורטיקואידים ומעכבי cyp3a (Concomitant administration of glucocorticoid receptor modulators and cyp3a inhibitors)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018160775		⤷ Sign Up
Japan	2019503495	異所性クッシング症候群の鑑別診断	⤷ 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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