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 |
---|---|
RTI International | Phase 1 |
Rochester General Hospital | Phase 1 |
Nova Southeastern University | 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 | ⤷ 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 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 | ⤷ 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 MIFEPREX
See the table below for patents covering MIFEPREX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 0196707 | 19-NOR STEROIDS SUBSTITUTED AT POSITIONS 11 AND 17 AND OPTIONALLY AT POSITION 2, THEIR PREPARATION, THEIR USE AS MEDICAMENTS, COMPOSITIONS CONTAINING THEM AND INTERMEDIATES OBTAINED | ⤷ Sign Up |
Spain | 8401498 | ⤷ Sign Up | |
Austria | 34664 | ⤷ Sign Up | |
Belgium | 1004905 | NOUVEAUX DERIVES 17BETA-OH 19-NOR STEROIDES SUBSTITUES EN 17ALPHA, LEUR PROCEDE DE PREPARATION, LEUR APPLICATION COMME MEDICAMENTS ET LES COMPOSITIONS PHARMACEUTIQUES LES RENFERMANT. | ⤷ Sign Up |
Bulgaria | 60768 | ⤷ Sign Up | |
Germany | 3262580 | ⤷ Sign Up | |
>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 | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |