Orange Book product · Brand (NDA)
WEGOVY
SEMAGLUTIDE
At a glance
Jun 04, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 04, 2021
5 yr 1 mo ago
Patent 8536122 expires
Listed drug substance patent expiration.
Mar 20, 2026
3 mo ago
Today
Exclusivity ends · I-935
New indication exclusivity (3 years)
Mar 08, 2027
in 9 mo
Exclusivity ends · I-973
New indication exclusivity (3 years)
Aug 15, 2028
in 2 yr 2 mo
Patent 8129343 expires
Listed drug substance patent expiration.
Dec 05, 2031
in 5 yr 7 mo
Patent 9764003 expires
Listed method-of-use patent (U-3161) expiration.
Jun 21, 2033
in 7 yr 1 mo
Patent 10888605 expires
Listed drug product patent expiration.
Aug 24, 2038
in 12 yr 4 mo
Patent 11752198 expires
Listed drug product patent expiration.
Aug 24, 2038
in 12 yr 4 mo
Patent 12214017 expires
Listed drug product patent expiration.
Aug 24, 2038
in 12 yr 4 mo
Patent 11478533 expires
Listed method-of-use patent (U-3861) expiration.
May 13, 2040
in 14 yr 1 mo
Patent 11318191 expires
Listed drug product patent expiration.
Feb 17, 2041
in 14 yr 11 mo
Pharmaceutical detail
Active ingredient
SEMAGLUTIDE
Strength
0.25MG/0.5ML (0.25MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 215256
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.
Marketing exclusivity (2)
- I-935New indication exclusivity (3 years)
Mar 08, 2027
in 9 mo
- I-973New indication exclusivity (3 years)
Aug 15, 2028
in 2 yr 2 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8536122 | Mar 20, 2026 | 3 mo ago | SubstanceProduct |
| 8129343 | Dec 05, 2031 | in 5 yr 7 mo | SubstanceProduct |
| 9764003 | Jun 21, 2033 | in 7 yr 1 mo | U-3161 |
| 10888605 | Aug 24, 2038 | in 12 yr 4 mo | ProductU-3162 |
| 11752198 | Aug 24, 2038 | in 12 yr 4 mo | ProductU-3162 |
| 12214017 | Aug 24, 2038 | in 12 yr 4 mo | ProductU-3162 |
| 11478533 | May 13, 2040 | in 14 yr 1 mo | U-3861 |
| 11318191 | Feb 17, 2041 | in 14 yr 11 mo | ProductU-3162 |
