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. Three 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.
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Summary for MIFEPREX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 25 |
| Patent Applications: | 5,130 |
| 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 |
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 |
|---|---|---|---|
| Spain | 2012197 | PROCEDIMIENTO PARA PREPARAR DERIVADOS 17BETA-OH-19-NOR-ESTEROIDES SUSTITUIDOS EN 17ALFA. (Novel 17 beta -hydroxy-19-nor-steroids) | ⤷ Sign Up |
| South Korea | 840000581 | ⤷ Sign Up | |
| Ireland | 820044 | ⤷ Sign Up | |
| Ireland | 842597 | ⤷ Sign Up | |
| Germany | 3844408 | In 17 alpha-Stellung substituierte 17ß-Hydroxy-19-norsteroid-Derivate, deren Herstellungsverfahren, und diese enthaltende pharmazeutische Zusammensetzungen | ⤷ 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 |
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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.
ISSN: 2162-2639
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