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Serving 500+ biopharmaceutical companies globally:

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Generated: June 26, 2017

DrugPatentWatch Database Preview

Mifepristone - Generic Drug Details

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What are the generic sources for mifepristone and what is the scope of mifepristone freedom to operate?

Mifepristone
is the generic ingredient in two branded drugs marketed by Corcept Therap and Danco Labs Llc, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for mifepristone. One supplier is listed for this compound.

Summary for Generic Name: mifepristone

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list5
Suppliers / Packagers: see list1
Bulk Api Vendors: see list55
Clinical Trials: see list140
Patent Applications: see list7,238
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mifepristone at DailyMed

Pharmacology for Ingredient: mifepristone

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;ORAL020687-001Sep 28, 2000RXYesYes► Subscribe► Subscribe
Corcept Therap
KORLYM
mifepristone
TABLET;ORAL202107-001Feb 17, 2012RXYesYes8,921,348► Subscribe ► Subscribe
Corcept Therap
KORLYM
mifepristone
TABLET;ORAL202107-001Feb 17, 2012RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mifepristone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Danco Labs Llc
MIFEPREX
mifepristone
TABLET;ORAL020687-001Sep 28, 20004,386,085► Subscribe
Danco Labs Llc
MIFEPREX
mifepristone
TABLET;ORAL020687-001Sep 28, 20004,626,531► Subscribe
Danco Labs Llc
MIFEPREX
mifepristone
TABLET;ORAL020687-001Sep 28, 20004,447,424► Subscribe
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Non-Orange Book Patents for Generic Ingredient: mifepristone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,598,149Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Covington
Farmers Insurance
Accenture
Mallinckrodt
QuintilesIMS
Julphar
Daiichi Sankyo
Deloitte
Citi
Moodys

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 verifification 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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