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 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 |
Pharmacology for MIFEPRISTONE
Drug Class | Progestin Antagonist |
Mechanism of Action | Progestational Hormone Receptor Antagonists |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
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
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
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 |
Japan | 2020509032 | 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 | ⤷ Try a Trial |
Canada | 3052668 | ADMINISTRATION CONCOMITANTE DE MODULATEURS DE RECEPTEUR DES GLUCOCORTICOIDES ET D'INHIBITEURS DE CYP3A (CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A INHIBITORS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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