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Generated: November 17, 2018

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Details for New Drug Application (NDA): 202107

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NDA 202107 describes KORLYM, which is a drug marketed by Corcept Therap and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KORLYM profile page.

The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mifepristone profile page.
Summary for 202107
Tradename:KORLYM
Applicant:Corcept Therap
Ingredient:mifepristone
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202107
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KORLYM mifepristone TABLET;ORAL 202107 NDA Corcept Therapeutics 76346-073 76346-073-01 28 TABLET in 1 BOTTLE (76346-073-01)
KORLYM mifepristone TABLET;ORAL 202107 NDA Corcept Therapeutics 76346-073 76346-073-02 280 TABLET in 1 BOTTLE (76346-073-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Feb 17, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 17, 2019
Regulatory Exclusivity Use:FOR THE CONTROL OF HYPERGLYCEMIA SECONDARY TO HYPERCORTISOLISM IN ADULT PATIENTS WITH ENDOGENOUS CUSHING'S SYNDROME WHO HAVE TYPE 2 DIABETES MELLITUS OR GLUCOSE INTOLERANCE AND HAVE FAILED SURGERY OR ARE NOT CANDIDATES FOR SURGERY
Patent:➤ Try a Free TrialPatent Expiration:Aug 12, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING CUSHING'S SYNDROME
Patent:➤ Try a Free TrialPatent Expiration:Aug 27, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING CUSHING'S SYNDROME

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