FDA Orange Book · active-ingredient family
Semaglutide
Semaglutide is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
4
Brand (NDA)
0
Generics (ANDA)
41
Listed patents
30
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OZEMPICRLD×7 | NOVO | NDA 209637 | — | May 05, 2026 | |
| WEGOVYRLD×4 | NOVO | NDA 218316 | — | Dec 22, 2025 | |
| OZEMPICRLD×6 | NOVO | NDA 213051 | — | Dec 09, 2024 | |
| WEGOVYRLD×11 | NOVO | NDA 215256 | — | Jun 04, 2021 |
Marketing exclusivity (30)
- I-961New indication exclusivity (3 years)
Jan 28, 2028
in 1 yr 8 mo
- I-961New indication exclusivity (3 years)
Jan 28, 2028
in 1 yr 8 mo
- I-961New indication exclusivity (3 years)
Jan 28, 2028
in 1 yr 8 mo
- I-961New indication exclusivity (3 years)
Jan 28, 2028
in 1 yr 8 mo
- 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
- 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
- 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
- D-190New indication / change exclusivity (3 years)
Jul 21, 2026
in 1 mo
- 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
- 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
- NSNew strength exclusivity (3 years)
Mar 19, 2029
in 2 yr 9 mo
- I-976New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
- I-976New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
- I-976New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
- I-976New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
- I-976New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
- I-976New indication exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
- I-935New indication exclusivity (3 years)
Mar 08, 2027
in 9 mo
- NPNew product exclusivity (3 years)
Dec 22, 2028
in 2 yr 7 mo
- I-935New indication exclusivity (3 years)
Mar 08, 2027
in 9 mo
- NPNew product exclusivity (3 years)
Dec 22, 2028
in 2 yr 7 mo
- I-935New indication exclusivity (3 years)
Mar 08, 2027
in 9 mo
- NPNew product exclusivity (3 years)
Dec 22, 2028
in 2 yr 7 mo
- I-935New indication exclusivity (3 years)
Mar 08, 2027
in 9 mo
- NPNew product exclusivity (3 years)
Dec 22, 2028
in 2 yr 7 mo
Listed patents (41)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10376652 | Jan 20, 2026 | 5 mo ago | ProductDelisted |
| 9861757 | Jan 20, 2026 | 5 mo ago | ProductDelisted |
| 9616180 | Jan 20, 2026 | 5 mo ago | ProductDelisted |
| 10357616 | Jan 20, 2026 | 5 mo ago | ProductDelisted |
| 9108002 | Jan 20, 2026 | 5 mo ago | ProductDelisted |
| 8536122 | Mar 20, 2026 | 3 mo ago | SubstanceProductU-2202 |
| 8920383 | Jul 17, 2026 | in 28 d | ProductDelisted |
| 9775953 | Jul 17, 2026 | in 28 d | ProductDelisted |
| 11097063 | Jul 17, 2026 | in 28 d | ProductDelisted |
| 10220155 | Jul 17, 2026 | in 28 d | ProductDelisted |
| RE46363 | Aug 03, 2026 | in 2 mo | ProductDelisted |
| 9687611 | Feb 27, 2027 | in 8 mo | ProductDelisted |
| 9457154 | Sep 29, 2027 | in 1 yr 4 mo | ProductDelisted |
| 8129343 | Dec 05, 2031 | in 5 yr 7 mo | SubstanceProductU-2202 |
| 11382957 | Dec 16, 2031 | in 5 yr 7 mo | SubstanceProduct |
| 9278123 | Dec 16, 2031 | in 5 yr 7 mo | SubstanceProductU-2628 |
| 10960052 | Dec 16, 2031 | in 5 yr 7 mo | Product |
| 10086047 | Dec 16, 2031 | in 5 yr 7 mo | Product |
| 9132239 | Feb 01, 2032 | in 5 yr 8 mo | ProductDelisted |
| 11759503 | Mar 15, 2033 | in 6 yr 10 mo | Product |
| 10933120 | Mar 15, 2033 | in 6 yr 10 mo | Product |
| 11759501 | Mar 15, 2033 | in 6 yr 10 mo | Product |
| 11759502 | Mar 15, 2033 | in 6 yr 10 mo | Product |
| 12594326 | Mar 15, 2033 | in 6 yr 10 mo | Product |
| 11033499 | Jun 19, 2033 | in 7 yr 1 mo | ProductU-2628 |
| 10335462 | Jun 21, 2033 | in 7 yr 1 mo | U-2580 |
| 9764003 | Jun 21, 2033 | in 7 yr 1 mo | U-3161 |
| 12514822 | May 02, 2034 | in 8 yr | U-2628 |
| 12239739 | May 02, 2034 | in 8 yr | SubstanceProductU-2628 |
| 10278923 | May 02, 2034 | in 8 yr | SubstanceProductU-2628 |
| 12569543 | Apr 28, 2037 | in 11 yr | U-4446 |
| 12214017 | Aug 24, 2038 | in 12 yr 4 mo | ProductU-3162 |
| 11752198 | Aug 24, 2038 | in 12 yr 4 mo | ProductU-3162 |
| 10888605 | Aug 24, 2038 | in 12 yr 4 mo | ProductU-3162 |
| 12295988 | Oct 10, 2038 | in 12 yr 6 mo | U-2628 |
| 12551536 | Oct 10, 2038 | in 12 yr 6 mo | U-4418 |
| 12029779 | Oct 10, 2038 | in 12 yr 6 mo | U-3162 |
| 11833248 | Feb 01, 2039 | in 12 yr 10 mo | ProductU-2628 |
| 12396953 | Feb 01, 2039 | in 12 yr 10 mo | ProductU-2628 |
| 11478533 | May 13, 2040 | in 14 yr 1 mo | U-3861 |
| 11318191 | Feb 17, 2041 | in 14 yr 11 mo | ProductU-3162 |
Semaglutide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
