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FDA Orange Book · active-ingredient family

Mifepristone

Mifepristone: 2 brands, 3 generics; first approved Sep 28, 2000; generic available.

Generic available
Generic status & protection

Generic available: 3 ANDA applications approved.

Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
3
Listed patents
18
Next patent expiry
Aug 27, 2028
in 1 yr 11 mo

Brand (NDA) products

Originator applications
  • KORLYMRLDRS
    NDA 2021072012
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    300MGTABLETORALRxAB
  • MIFEPREXRLDRS
    NDA 0206872000
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    200MGTABLETORALRxAB

Generic (ANDA) products (3)

Abbreviated applications
  • MIFEPRISTONE
    ANDA 2166162025
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    200MGTABLETORALRxAB
  • MIFEPRISTONE
    ANDA 2114362020
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    300MGTABLETORALRxAB
  • MIFEPRISTONE
    ANDA 0911782019
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    200MGTABLETORALRxAB

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 8921348: 2028-08-27Patent 8921348Patent 10842801: 2032-11-15Patent 10842801Patent 10500216: 2033-03-05Patent 10500216Patent 10166243: 2036-04-20Patent 10166243Patent 9943526: 2036-04-20Patent 9943526Patent 10166242: 2036-04-20Patent 10166242Patent 10660904: 2036-04-20Patent 10660904Patent 10495650: 2036-08-12Patent 10495650Patent 10006924: 2036-08-12Patent 10006924Patent 9829495: 2036-08-15Patent 9829495Patent 10151763: 2037-01-18Patent 10151763Patent 11969435: 2037-06-19Patent 11969435Patent 12097210: 2037-06-19Patent 12097210Patent 10195214: 2037-06-19Patent 10195214Patent 10842800: 2037-06-19Patent 10842800Patent 10231983: 2038-08-22Patent 10231983Patent 10314850: 2038-08-22Patent 10314850Patent 10780097: 2038-08-22Patent 10780097
Patent expiryExclusivity endToday

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8921348in 1 yr 11 mo
U-1643
10842801in 6 yr 2 mo
U-1643
10500216in 6 yr 6 mo
U-1643
10166243in 9 yr 8 mo
U-1643
9943526in 9 yr 8 mo
U-1643
10166242in 9 yr 8 mo
U-1643
10660904in 9 yr 8 mo
U-1643
10495650in 10 yr
U-1643
10006924in 10 yr
U-1643
9829495in 10 yr
U-1643
10151763in 10 yr 5 mo
U-1643
11969435in 10 yr 10 mo
U-1643
12097210in 10 yr 10 mo
U-1643
10195214in 10 yr 10 mo
U-1643
10842800in 10 yr 10 mo
U-1643
10231983in 12 yr
U-1643
10314850in 12 yr
U-1643
10780097in 12 yr
U-1643

Approval history

FDA approval span
First approval
26 yr 5 mo ago
Most recent approval
1 yr 1 mo ago

Approvals span 2000–2025 across 5 FDA applications.

Brand (NDA) 240%
Generic (ANDA) 360%

Mifepristone: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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