Orange Book product · Brand (NDA)
NEXPLANON
ETONOGESTREL
At a glance
May 13, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 13, 2011
15 yr 4 mo ago
Today
Patent 8888745 expires
Listed drug product patent expiration.
Aug 28, 2026
in 2 mo
Patent 10821277 expires
Listed drug product patent expiration.
May 31, 2027
in 1 yr
Patent 8722037 expires
Listed drug product patent expiration.
Sep 28, 2027
in 1 yr 4 mo
Exclusivity ends · D-199
New indication / change exclusivity (3 years)
Jan 16, 2029
in 2 yr 7 mo
Patent 9757552 expires
Listed drug product patent expiration.
Jul 28, 2030
in 4 yr 2 mo
Pharmaceutical detail
Active ingredient
ETONOGESTREL
Strength
68MG/IMPLANT
Dosage form
IMPLANT
Route
IMPLANTATION
TE code
Not listed
Application
NDA 021529
Product number
002
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.
Marketing exclusivity (1)
- D-199New indication / change exclusivity (3 years)
Jan 16, 2029
in 2 yr 7 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8888745 | Aug 28, 2026 | in 2 mo | Product |
| 10821277 | May 31, 2027 | in 1 yr | Product |
| 8722037 | Sep 28, 2027 | in 1 yr 4 mo | Product |
| 9757552 | Jul 28, 2030 | in 4 yr 2 mo | ProductU-1 |
