Orange Book product · Brand (NDA)
ORSERDU
ELACESTRANT HYDROCHLORIDE
At a glance
Jan 27, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 2023
3 yr 5 mo ago
Today
Patent 7612114 expires
Listed drug substance patent expiration.
Aug 18, 2026
in 2 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 27, 2028
in 1 yr 8 mo
Patent 10071066 expires
Listed method-of-use patent (U-3524) expiration.
Oct 10, 2034
in 8 yr 5 mo
Patent 11779552 expires
Listed method-of-use patent (U-3524) expiration.
Oct 10, 2034
in 8 yr 5 mo
Patent 10420734 expires
Listed method-of-use patent (U-3524) expiration.
Oct 03, 2036
in 10 yr 5 mo
Patent 11819480 expires
Listed method-of-use patent (U-3523) expiration.
Feb 28, 2037
in 10 yr 10 mo
Patent 10385008 expires
Listed drug substance patent expiration.
Jan 05, 2038
in 11 yr 9 mo
Patent 10745343 expires
Listed method-of-use patent (U-3523) expiration.
Jan 05, 2038
in 11 yr 9 mo
Pharmaceutical detail
Active ingredient
ELACESTRANT HYDROCHLORIDE
Strength
EQ 86MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217639
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Jan 27, 2028
in 1 yr 8 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7612114 | Aug 18, 2026 | in 2 mo | SubstanceProductU-3523 |
| 10071066 | Oct 10, 2034 | in 8 yr 5 mo | U-3524 |
| 11779552 | Oct 10, 2034 | in 8 yr 5 mo | U-3524 |
| 10420734 | Oct 03, 2036 | in 10 yr 5 mo | U-3524 |
| 11819480 | Feb 28, 2037 | in 10 yr 10 mo | U-3523 |
| 10385008 | Jan 05, 2038 | in 11 yr 9 mo | SubstanceProduct |
| 10745343 | Jan 05, 2038 | in 11 yr 9 mo | U-3523 |
