exenatide synthetic · Astrazeneca Ab · NDA 209210
Bydureon Bcise
Earliest generic entry, as listed
4 Apr 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8895033 (pediatric extension).
Listed patents · 6 unexpired
16 Orange Book listing rows for 6 patents, including 6 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8895033 | drug product, use U-2589, U-2590, U-2597, U-2601, U-2602, U-3188, U-3189, U-3190 | 4 Apr 2031 |
| US 8895033 listing row | drug product, use U-2589 | 4 Oct 2030 |
| US 8895033 listing row | drug product, use U-2590 | 4 Oct 2030 |
| US 8895033 listing row | drug product, use U-2597 | 4 Oct 2030 |
| US 8895033 listing row | drug product, use U-2601 | 4 Oct 2030 |
| US 8895033 listing row | drug product, use U-2602 | 4 Oct 2030 |
| US 8895033 listing row | drug product, use U-3188 | 4 Oct 2030 |
| US 8895033 listing row | drug product, use U-3189 | 4 Oct 2030 |
| US 8895033 listing row | drug product, use U-3190 | 4 Oct 2030 |
| US 8895033 listing row | pediatric extension · sets the listed date | 4 Apr 2031 |
| US 8361972 | use U-2588 | 21 Sep 2028 |
| US 8361972 listing row | use U-2588 | 21 Mar 2028 |
| US 8361972 listing row | pediatric extension | 21 Sep 2028 |
| US 8501698 | use U-2588 | 20 Dec 2027 |
| US 8501698 listing row | use U-2588 | 20 Jun 2027 |
| US 8501698 listing row | pediatric extension | 20 Dec 2027 |
| US 8329648 | pediatric extension | 18 Feb 2027 |
| US 8906851 | pediatric extension | 18 Feb 2027 |
| US 9884092 | pediatric extension | 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 |
|---|---|---|---|
| 209210 · 001 · RLD · discontinued | suspension, extended release, subcutaneous | 2MG/0.85ML (2MG/0.85ML) | 4 Apr 2031 |
Expired or delisted (31)
- US 8329648 · use U-3190 · 18 Aug 2026
- US 8329648 · use U-2590 · 18 Aug 2026
- US 8329648 · use U-2593 · 18 Aug 2026
- US 8329648 · use U-2594 · 18 Aug 2026
- US 8329648 · use U-2596 · 18 Aug 2026
- US 8329648 · use U-2595 · 18 Aug 2026
- US 8329648 · use U-2588 · 18 Aug 2026
- US 8329648 · use U-2589 · 18 Aug 2026
- US 8329648 · use U-3189 · 18 Aug 2026
- US 8329648 · use U-3188 · 18 Aug 2026
- US 8906851 · use U-2590 · 18 Aug 2026
- US 8906851 · use U-3188 · 18 Aug 2026
- US 8906851 · use U-3189 · 18 Aug 2026
- US 8906851 · use U-2588 · 18 Aug 2026
- US 8906851 · use U-3190 · 18 Aug 2026
- US 8906851 · use U-2589 · 18 Aug 2026
- US 8906851 · use U-2597 · 18 Aug 2026
- US 8906851 · use U-2593 · 18 Aug 2026
- US 9884092 · use U-3189 · 18 Aug 2026
- US 9884092 · use U-2593 · 18 Aug 2026
- US 9884092 · use U-2595 · 18 Aug 2026
- US 9884092 · use U-2597 · 18 Aug 2026
- US 9884092 · use U-2596 · 18 Aug 2026
- US 9884092 · use U-2594 · 18 Aug 2026
- US 9884092 · use U-2589 · 18 Aug 2026
- US 9884092 · use U-2588 · 18 Aug 2026
- US 9884092 · use U-3188 · 18 Aug 2026
- US 9884092 · use U-3190 · 18 Aug 2026
- US 9884092 · use U-2590 · 18 Aug 2026
- US 6515117 · — · 4 Apr 2026
- US 6515117 · substance, product, use U-2588 · 4 Oct 2025