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 |
|---|---|
| Nova Southeastern University | Phase 1 |
| RTI International | Phase 1 |
| Rochester General Hospital | 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 |
|---|---|---|---|
| Germany | 3471588 | ⤷ Try a Trial | |
| 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. | ⤷ Try a Trial |
| Ireland | 820044 | ⤷ Try a Trial | |
| Ireland | 842597 | ⤷ Try a Trial | |
| Spain | 508588 | ⤷ 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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