Skip to content
Assyro AI
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 10 mo

Brand (NDA) products

Originator applications
Ask AI
  • 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
Ask AI
  • 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
Ask AI
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
Ask AI
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8921348in 1 yr 10 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 9 yr 11 mo
U-1643
10006924in 9 yr 11 mo
U-1643
9829495in 9 yr 11 mo
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
Ask AI
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.

Related FDA reference tools

Assyro Intelligence

Ask anything about Mifepristone

Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.

  • PubMed
  • ClinicalTrials.gov
  • FDA
  • Health Canada
  • EMA
  • ICH

Evaluating for a team? Book a demo