Mifepristone - Generic Drug Details
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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 |
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
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 |
---|---|---|---|
Japan | 7218294 | ⤷ Try a Trial | |
Mexico | 2018008849 | DIAGNOSTICO DIFERENCIAL DE SINDROME DE CUSHING ECTOPICO. (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME.) | ⤷ Try a Trial |
Israel | 257439 | שיטות לאבחון מבדיל של סינדרום קושינג תלוי הורמון אדרנוקורטיקוטרופי (Method for differentially diagnosing acth-dependent cushing's syndrome) | ⤷ Try a Trial |
Hong Kong | 1255714 | 鑑別診斷ACTH依賴性庫欣綜合症的方法 (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME) | ⤷ Try a Trial |
Japan | 2018529941 | ACTH依存性クッシング症候群を鑑別診断する方法 | ⤷ Try a Trial |
South Korea | 20190122239 | 글루코코르티코이드 수용체 조정제 및 CYP3A 억제제의 병용 투여 | ⤷ Try a Trial |
Japan | 6765443 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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