FDA Orange Book · active-ingredient family
Exenatide synthetic
Exenatide synthetic is approved as 3 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BYDUREON BCISE · NDA 209210
3
Brand (NDA)
1
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, extended release, injectable, suspension, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BYDUREON BCISERLD | ASTRAZENECA AB | NDA 209210 | — | Oct 20, 2017 | |
| BYDUREONRLD×2 | ASTRAZENECA AB | NDA 022200 | — | Jan 27, 2012 | |
| BYETTARLD×2 | ASTRAZENECA AB | NDA 021773 | — | Apr 28, 2005 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXENATIDE SYNTHETIC×2 | AMNEAL | ANDA 206697 | — | Nov 19, 2024 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6515117 | Oct 04, 2025 | 9 mo ago | SubstanceProductU-2588 |
| 6515117*PED | Apr 04, 2026 | 3 mo ago | |
| 8329648 | Aug 18, 2026 | in 2 mo | U-2590 |
| 8906851 | Aug 18, 2026 | in 2 mo | U-2593 |
| 9884092 | Aug 18, 2026 | in 2 mo | U-2593 |
| 8329648*PED | Feb 18, 2027 | in 8 mo | |
| 8906851*PED | Feb 18, 2027 | in 8 mo | |
| 9884092*PED | Feb 18, 2027 | in 8 mo | |
| 8501698 | Jun 20, 2027 | in 1 yr | ProductU-2588 |
| 8501698*PED | Dec 20, 2027 | in 1 yr 6 mo | |
| 8361972 | Mar 21, 2028 | in 1 yr 9 mo | U-2588 |
| 8361972*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8895033 | Oct 04, 2030 | in 4 yr 4 mo | ProductU-2597 |
| 8895033*PED | Apr 04, 2031 | in 4 yr 10 mo |
Exenatide synthetic — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
