You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 25, 2024

Mifepristone - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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.

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Genbiopro	MIFEPRISTONE	mifepristone	TABLET;ORAL	091178-001	Apr 11, 2019	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
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
>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

Subscribe to access the full database, or Try a Trial
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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018160775		⤷ Try a Trial
Spain	2861524		⤷ Try a Trial
Canada	3011728	DIAGNOSTIC DIFFERENTIEL DU SYNDROME DE CUSHING ECTOPIQUE (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME)	⤷ Try a Trial
South Korea	20180052120	ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.