Orange Book product · Brand (NDA)
KORLYM
MIFEPRISTONE
At a glance
Feb 17, 2012
Approved
Brand (NDA)
Application
AB
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2012
14 yr 7 mo ago
Today
Patent 8921348 expires
Listed method-of-use patent (U-1643) expiration.
Aug 27, 2028
in 2 yr 3 mo
Patent 10842801 expires
Listed method-of-use patent (U-1643) expiration.
Nov 15, 2032
in 6 yr 6 mo
Patent 10500216 expires
Listed method-of-use patent (U-1643) expiration.
Mar 05, 2033
in 6 yr 10 mo
Patent 10166242 expires
Listed method-of-use patent (U-1643) expiration.
Apr 20, 2036
in 10 yr
Patent 10166243 expires
Listed method-of-use patent (U-1643) expiration.
Apr 20, 2036
in 10 yr
Patent 10660904 expires
Listed method-of-use patent (U-1643) expiration.
Apr 20, 2036
in 10 yr
Patent 9943526 expires
Listed method-of-use patent (U-1643) expiration.
Apr 20, 2036
in 10 yr
Patent 10006924 expires
Listed method-of-use patent (U-1643) expiration.
Aug 12, 2036
in 10 yr 4 mo
Patent 10495650 expires
Listed method-of-use patent (U-1643) expiration.
Aug 12, 2036
in 10 yr 4 mo
Patent 9829495 expires
Listed method-of-use patent (U-1643) expiration.
Aug 15, 2036
in 10 yr 4 mo
Patent 10151763 expires
Listed method-of-use patent (U-1643) expiration.
Jan 18, 2037
in 10 yr 9 mo
Patent 10195214 expires
Listed method-of-use patent (U-1643) expiration.
Jun 19, 2037
in 11 yr 2 mo
Patent 10842800 expires
Listed method-of-use patent (U-1643) expiration.
Jun 19, 2037
in 11 yr 2 mo
Patent 11969435 expires
Listed method-of-use patent (U-1643) expiration.
Jun 19, 2037
in 11 yr 2 mo
Patent 12097210 expires
Listed method-of-use patent (U-1643) expiration.
Jun 19, 2037
in 11 yr 2 mo
Patent 10231983 expires
Listed method-of-use patent (U-1643) expiration.
Aug 22, 2038
in 12 yr 4 mo
Patent 10314850 expires
Listed method-of-use patent (U-1643) expiration.
Aug 22, 2038
in 12 yr 4 mo
Patent 10780097 expires
Listed method-of-use patent (U-1643) expiration.
Aug 22, 2038
in 12 yr 4 mo
Pharmaceutical detail
Active ingredient
MIFEPRISTONE
Strength
300MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 202107
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8921348 | Aug 27, 2028 | in 2 yr 3 mo | U-1643 |
| 10842801 | Nov 15, 2032 | in 6 yr 6 mo | U-1643 |
| 10500216 | Mar 05, 2033 | in 6 yr 10 mo | U-1643 |
| 10166242 | Apr 20, 2036 | in 10 yr | U-1643 |
| 10166243 | Apr 20, 2036 | in 10 yr | U-1643 |
| 10660904 | Apr 20, 2036 | in 10 yr | U-1643 |
| 9943526 | Apr 20, 2036 | in 10 yr | U-1643 |
| 10006924 | Aug 12, 2036 | in 10 yr 4 mo | U-1643 |
| 10495650 | Aug 12, 2036 | in 10 yr 4 mo | U-1643 |
| 9829495 | Aug 15, 2036 | in 10 yr 4 mo | U-1643 |
| 10151763 | Jan 18, 2037 | in 10 yr 9 mo | U-1643 |
| 10195214 | Jun 19, 2037 | in 11 yr 2 mo | U-1643 |
| 10842800 | Jun 19, 2037 | in 11 yr 2 mo | U-1643 |
| 11969435 | Jun 19, 2037 | in 11 yr 2 mo | U-1643 |
| 12097210 | Jun 19, 2037 | in 11 yr 2 mo | U-1643 |
| 10231983 | Aug 22, 2038 | in 12 yr 4 mo | U-1643 |
| 10314850 | Aug 22, 2038 | in 12 yr 4 mo | U-1643 |
| 10780097 | Aug 22, 2038 | in 12 yr 4 mo | U-1643 |
