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 seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Mifepristone has thirty-eight 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: | 38 |
US Patents: | 17 |
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 |
Pharmacology for mifepristone
Drug Class | Progestin Antagonist |
Mechanism of Action | Progestational Hormone Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for mifepristone
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Genbiopro | MIFEPRISTONE | mifepristone | TABLET;ORAL | 091178-001 | Apr 11, 2019 | AB | RX | No | No | ⤷ 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
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20180052120 | ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법 | ⤷ Sign Up |
Canada | 2994422 | PROCEDE PERMETTANT D'ETABLIR UN DIAGNOSTIC DIFFERENTIEL DU SYNDROME DE CUSHING EN FONCTION DE L'HORMONE ADRENOCORTICOTROPE (ACTH) (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME) | ⤷ Sign Up |
European Patent Office | 3405101 | DIAGNOSTIC DIFFÉRENTIEL DU SYNDROME DE CUSHING ECTOPIQUE (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME) | ⤷ Sign Up |
Japan | 7516586 | ⤷ 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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