Orange Book product · Brand (NDA)
OZEMPIC
SEMAGLUTIDE
At a glance
Dec 09, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 09, 2024
1 yr 7 mo ago
Patent 8536122 expires
Listed drug substance patent expiration.
Mar 20, 2026
3 mo ago
Today
Exclusivity ends · I-976
New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
Patent 8129343 expires
Listed drug substance patent expiration.
Dec 05, 2031
in 5 yr 7 mo
Patent 11382957 expires
Listed drug substance patent expiration.
Dec 16, 2031
in 5 yr 7 mo
Patent 11033499 expires
Listed drug product patent expiration.
Jun 19, 2033
in 7 yr 1 mo
Patent 10278923 expires
Listed drug substance patent expiration.
May 02, 2034
in 8 yr
Patent 12239739 expires
Listed drug substance patent expiration.
May 02, 2034
in 8 yr
Patent 12514822 expires
Listed method-of-use patent (U-2628) expiration.
May 02, 2034
in 8 yr
Patent 11833248 expires
Listed drug product patent expiration.
Feb 01, 2039
in 12 yr 10 mo
Patent 12396953 expires
Listed drug product patent expiration.
Feb 01, 2039
in 12 yr 10 mo
Pharmaceutical detail
Active ingredient
SEMAGLUTIDE
Strength
1.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213051
Product number
004
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)
- I-976New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8536122 | Mar 20, 2026 | 3 mo ago | SubstanceProductU-2628 |
| 8129343 | Dec 05, 2031 | in 5 yr 7 mo | SubstanceProductU-2628 |
| 11382957 | Dec 16, 2031 | in 5 yr 7 mo | SubstanceProduct |
| 11033499 | Jun 19, 2033 | in 7 yr 1 mo | ProductU-2628 |
| 10278923 | May 02, 2034 | in 8 yr | SubstanceProductU-2628 |
| 12239739 | May 02, 2034 | in 8 yr | SubstanceProductU-2628 |
| 12514822 | May 02, 2034 | in 8 yr | U-2628 |
| 11833248 | Feb 01, 2039 | in 12 yr 10 mo | ProductU-2628 |
| 12396953 | Feb 01, 2039 | in 12 yr 10 mo | ProductU-2628 |
