exenatide synthetic · Astrazeneca Ab · NDA 022200
Bydureon Pen
Earliest generic entry, as listed
21 Sep 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8361972.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8361972 | — | 21 Sep 2028 |
| US 8361972 | use U-2588 | 21 Mar 2028 |
| US 8501698 | — | 20 Dec 2027 |
| US 8501698 | product, use U-2588 | 20 Jun 2027 |
| US 8329648 | — | 18 Feb 2027 |
| US 8906851 | — | 18 Feb 2027 |
| US 9884092 | — | 18 Feb 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022200 · 002 · RLD · discontinued | for suspension, extended release, subcutaneous | 2MG | 21 Sep 2028 |
Expired or delisted (29)
- US 8329648 · use U-3188 · 18 Aug 2026
- US 8329648 · use U-2594 · 18 Aug 2026
- US 8329648 · use U-2595 · 18 Aug 2026
- US 8329648 · use U-2589 · 18 Aug 2026
- US 8329648 · use U-2588 · 18 Aug 2026
- US 8329648 · use U-2590 · 18 Aug 2026
- US 8329648 · use U-2593 · 18 Aug 2026
- US 8329648 · use U-3189 · 18 Aug 2026
- US 8329648 · use U-3190 · 18 Aug 2026
- US 8329648 · use U-2596 · 18 Aug 2026
- US 8906851 · use U-2589 · 18 Aug 2026
- US 8906851 · use U-2593 · 18 Aug 2026
- US 8906851 · use U-2590 · 18 Aug 2026
- US 8906851 · use U-2588 · 18 Aug 2026
- US 8906851 · use U-3188 · 18 Aug 2026
- US 8906851 · use U-3190 · 18 Aug 2026
- US 8906851 · use U-3189 · 18 Aug 2026
- US 9884092 · use U-2589 · 18 Aug 2026
- US 9884092 · use U-2588 · 18 Aug 2026
- US 9884092 · use U-2594 · 18 Aug 2026
- US 9884092 · use U-2590 · 18 Aug 2026
- US 9884092 · use U-2596 · 18 Aug 2026
- US 9884092 · use U-2595 · 18 Aug 2026
- US 9884092 · use U-2593 · 18 Aug 2026
- US 9884092 · use U-3189 · 18 Aug 2026
- US 9884092 · use U-3190 · 18 Aug 2026
- US 9884092 · use U-3188 · 18 Aug 2026
- US 6515117 · — · 4 Apr 2026
- US 6515117 · substance, product, use U-2588 · 4 Oct 2025