MIFEPREX Drug Patent Profile
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Which patents cover Mifeprex, and when can generic versions of Mifeprex launch?
Mifeprex is a drug marketed by Danco Labs Llc and is included in one NDA.
The generic ingredient in MIFEPREX is mifepristone. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mifeprex
A generic version of MIFEPREX was approved as mifepristone by GENBIOPRO on April 11th, 2019.
Summary for MIFEPREX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 25 |
Patent Applications: | 5,832 |
Formulation / Manufacturing: | see details |
DailyMed Link: | MIFEPREX at DailyMed |
Recent Clinical Trials for MIFEPREX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Rochester General Hospital | Phase 1 |
Nova Southeastern University | Phase 1 |
RTI International | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for MIFEPREX
US Patents and Regulatory Information for MIFEPREX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Danco Labs Llc | MIFEPREX | mifepristone | TABLET;ORAL | 020687-001 | Sep 28, 2000 | 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 MIFEPREX
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 MIFEPREX
See the table below for patents covering MIFEPREX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Sweden | 8804692 | ⤷ Try a Trial | |
Italy | 1235358 | DERIVATI 17BETA-OH 19-NOR STEROIDEI SOSTITUITI IN 17ALFA, PROCEDIMENTO DI PREPARAZIONE, LORO IMPIEGO COME MEDICAMENTI E COMPOSIZIONI FARMACEUTICHE CHE LI COMPONGONO | ⤷ Try a Trial |
Germany | 3262580 | ⤷ Try a Trial | |
United Kingdom | 2213484 | NEW DERIVATIVES OF 17BETA-OH 19-NOR STEROIDS SUBSTITUTED IN THE 17 ALPHA POSITION, THEIR PREPARATION, THEIR USE AS MEDICAMENTS AND PHARMACEUTICAL COMPOSITIONS | ⤷ Try a Trial |
Denmark | 164477 | ⤷ Try a Trial | |
South Korea | 870001936 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MIFEPREX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0057115 | SPC/GB93/030 | United Kingdom | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |