Assyro AI

Orange Book product · Brand (NDA)

BYDUREON PEN

EXENATIDE SYNTHETIC

Brand (NDA)NDA 022200DISCN ASTRAZENECA AB
View EXENATIDE SYNTHETIC familyOpen on FDA Orange Book

At a glance

Feb 28, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

36

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 28, 2014

    12 yr 6 mo ago

  2. Patent 6515117 expires

    Listed drug substance patent expiration.

    Oct 04, 2025

    9 mo ago

  3. Patent 6515117*PED expires

    Listed listed patent expiration.

    Apr 04, 2026

    3 mo ago

  4. Today

  5. Patent 8329648 expires

    Listed method-of-use patent (U-2596) expiration.

    Aug 18, 2026

    in 2 mo

  6. Patent 8329648 expires

    Listed method-of-use patent (U-2595) expiration.

    Aug 18, 2026

    in 2 mo

  7. Patent 8329648 expires

    Listed method-of-use patent (U-2589) expiration.

    Aug 18, 2026

    in 2 mo

  8. Patent 8329648 expires

    Listed method-of-use patent (U-2588) expiration.

    Aug 18, 2026

    in 2 mo

  9. Patent 8329648 expires

    Listed method-of-use patent (U-2590) expiration.

    Aug 18, 2026

    in 2 mo

  10. Patent 8329648 expires

    Listed method-of-use patent (U-2593) expiration.

    Aug 18, 2026

    in 2 mo

  11. Patent 8329648 expires

    Listed method-of-use patent (U-2594) expiration.

    Aug 18, 2026

    in 2 mo

  12. Patent 8329648 expires

    Listed method-of-use patent (U-3189) expiration.

    Aug 18, 2026

    in 2 mo

  13. Patent 8329648 expires

    Listed method-of-use patent (U-3190) expiration.

    Aug 18, 2026

    in 2 mo

  14. Patent 8329648 expires

    Listed method-of-use patent (U-3188) expiration.

    Aug 18, 2026

    in 2 mo

  15. Patent 8906851 expires

    Listed method-of-use patent (U-2588) expiration.

    Aug 18, 2026

    in 2 mo

  16. Patent 8906851 expires

    Listed method-of-use patent (U-2589) expiration.

    Aug 18, 2026

    in 2 mo

  17. Patent 8906851 expires

    Listed method-of-use patent (U-2593) expiration.

    Aug 18, 2026

    in 2 mo

  18. Patent 8906851 expires

    Listed method-of-use patent (U-2590) expiration.

    Aug 18, 2026

    in 2 mo

  19. Patent 8906851 expires

    Listed method-of-use patent (U-3189) expiration.

    Aug 18, 2026

    in 2 mo

  20. Patent 8906851 expires

    Listed method-of-use patent (U-3190) expiration.

    Aug 18, 2026

    in 2 mo

  21. Patent 8906851 expires

    Listed method-of-use patent (U-3188) expiration.

    Aug 18, 2026

    in 2 mo

  22. Patent 9884092 expires

    Listed method-of-use patent (U-2588) expiration.

    Aug 18, 2026

    in 2 mo

  23. Patent 9884092 expires

    Listed method-of-use patent (U-2594) expiration.

    Aug 18, 2026

    in 2 mo

  24. Patent 9884092 expires

    Listed method-of-use patent (U-2590) expiration.

    Aug 18, 2026

    in 2 mo

  25. Patent 9884092 expires

    Listed method-of-use patent (U-2596) expiration.

    Aug 18, 2026

    in 2 mo

  26. Patent 9884092 expires

    Listed method-of-use patent (U-2589) expiration.

    Aug 18, 2026

    in 2 mo

  27. Patent 9884092 expires

    Listed method-of-use patent (U-2595) expiration.

    Aug 18, 2026

    in 2 mo

  28. Patent 9884092 expires

    Listed method-of-use patent (U-2593) expiration.

    Aug 18, 2026

    in 2 mo

  29. Patent 9884092 expires

    Listed method-of-use patent (U-3189) expiration.

    Aug 18, 2026

    in 2 mo

  30. Patent 9884092 expires

    Listed method-of-use patent (U-3190) expiration.

    Aug 18, 2026

    in 2 mo

  31. Patent 9884092 expires

    Listed method-of-use patent (U-3188) expiration.

    Aug 18, 2026

    in 2 mo

  32. Patent 8329648*PED expires

    Listed listed patent expiration.

    Feb 18, 2027

    in 8 mo

  33. Patent 8906851*PED expires

    Listed listed patent expiration.

    Feb 18, 2027

    in 8 mo

  34. Patent 9884092*PED expires

    Listed listed patent expiration.

    Feb 18, 2027

    in 8 mo

  35. Patent 8501698 expires

    Listed drug product patent expiration.

    Jun 20, 2027

    in 1 yr

  36. Patent 8501698*PED expires

    Listed listed patent expiration.

    Dec 20, 2027

    in 1 yr 6 mo

  37. Patent 8361972 expires

    Listed method-of-use patent (U-2588) expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  38. Patent 8361972*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

Pharmaceutical detail

Active ingredient

EXENATIDE SYNTHETIC

Strength

2MG

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 022200

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (36)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
6515117Oct 04, 20259 mo ago
SubstanceProductU-2588
6515117*PEDApr 04, 20263 mo ago
8329648Aug 18, 2026in 2 mo
U-2596
8329648Aug 18, 2026in 2 mo
U-2595
8329648Aug 18, 2026in 2 mo
U-2589
8329648Aug 18, 2026in 2 mo
U-2588
8329648Aug 18, 2026in 2 mo
U-2590
8329648Aug 18, 2026in 2 mo
U-2593
8329648Aug 18, 2026in 2 mo
U-2594
8329648Aug 18, 2026in 2 mo
U-3189
8329648Aug 18, 2026in 2 mo
U-3190
8329648Aug 18, 2026in 2 mo
U-3188
8906851Aug 18, 2026in 2 mo
U-2588
8906851Aug 18, 2026in 2 mo
U-2589
8906851Aug 18, 2026in 2 mo
U-2593
8906851Aug 18, 2026in 2 mo
U-2590
8906851Aug 18, 2026in 2 mo
U-3189
8906851Aug 18, 2026in 2 mo
U-3190
8906851Aug 18, 2026in 2 mo
U-3188
9884092Aug 18, 2026in 2 mo
U-2588
9884092Aug 18, 2026in 2 mo
U-2594
9884092Aug 18, 2026in 2 mo
U-2590
9884092Aug 18, 2026in 2 mo
U-2596
9884092Aug 18, 2026in 2 mo
U-2589
9884092Aug 18, 2026in 2 mo
U-2595
9884092Aug 18, 2026in 2 mo
U-2593
9884092Aug 18, 2026in 2 mo
U-3189
9884092Aug 18, 2026in 2 mo
U-3190
9884092Aug 18, 2026in 2 mo
U-3188
8329648*PEDFeb 18, 2027in 8 mo
8906851*PEDFeb 18, 2027in 8 mo
9884092*PEDFeb 18, 2027in 8 mo
8501698Jun 20, 2027in 1 yr
ProductU-2588
8501698*PEDDec 20, 2027in 1 yr 6 mo
8361972Mar 21, 2028in 1 yr 9 mo
U-2588
8361972*PEDSep 21, 2028in 2 yr 4 mo
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