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FDA Orange Book · active-ingredient family

Mifepristone

Mifepristone is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KORLYM · NDA 202107

2

Brand (NDA)

3

Generics (ANDA)

18

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
KORLYMRLDCORCEPT THERAPNDA 202107ABFeb 17, 2012
MIFEPREXRLDDANCO LABS LLCNDA 020687ABSep 28, 2000

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
MIFEPRISTONEEVITA SOLUTIONSANDA 216616ABSep 30, 2025
MIFEPRISTONETEVA PHARMS USA INCANDA 211436ABAug 03, 2020
MIFEPRISTONEGENBIOPROANDA 091178ABApr 11, 2019

Listed patents (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8921348Aug 27, 2028in 2 yr 3 mo
U-1643
10842801Nov 15, 2032in 6 yr 6 mo
U-1643
10500216Mar 05, 2033in 6 yr 10 mo
U-1643
10166243Apr 20, 2036in 10 yr
U-1643
9943526Apr 20, 2036in 10 yr
U-1643
10166242Apr 20, 2036in 10 yr
U-1643
10660904Apr 20, 2036in 10 yr
U-1643
10495650Aug 12, 2036in 10 yr 4 mo
U-1643
10006924Aug 12, 2036in 10 yr 4 mo
U-1643
9829495Aug 15, 2036in 10 yr 4 mo
U-1643
10151763Jan 18, 2037in 10 yr 9 mo
U-1643
11969435Jun 19, 2037in 11 yr 2 mo
U-1643
12097210Jun 19, 2037in 11 yr 2 mo
U-1643
10195214Jun 19, 2037in 11 yr 2 mo
U-1643
10842800Jun 19, 2037in 11 yr 2 mo
U-1643
10231983Aug 22, 2038in 12 yr 4 mo
U-1643
10314850Aug 22, 2038in 12 yr 4 mo
U-1643
10780097Aug 22, 2038in 12 yr 4 mo
U-1643

Mifepristone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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