Assyro AI

Orange Book product · Brand (NDA)

JARDIANCE

EMPAGLIFLOZIN

Brand (NDA)NDA 204629RX BOEHRINGER INGELHEIM

At a glance

Aug 01, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

35

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 01, 2014

    12 yr 1 mo ago

  2. Today

  3. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    Jun 20, 2026

    in 1 d

  4. Exclusivity ends · I-922

    New indication exclusivity (3 years)

    Sep 21, 2026

    in 3 mo

  5. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Dec 20, 2026

    in 6 mo

  6. Patent 7713938 expires

    Listed drug substance patent expiration.

    Apr 15, 2027

    in 10 mo

  7. Patent 7713938*PED expires

    Listed listed patent expiration.

    Oct 15, 2027

    in 1 yr 4 mo

  8. Patent 7579449 expires

    Listed drug substance patent expiration.

    Aug 01, 2028

    in 2 yr 2 mo

  9. Patent 7579449*PED expires

    Listed listed patent expiration.

    Feb 01, 2029

    in 2 yr 8 mo

  10. Patent 8551957 expires

    Listed method-of-use patent (U-1651) expiration.

    Oct 14, 2029

    in 3 yr 4 mo

  11. Patent 12115179 expires

    Listed method-of-use patent (U-4023) expiration.

    Feb 11, 2030

    in 3 yr 8 mo

  12. Patent 8551957*PED expires

    Listed listed patent expiration.

    Apr 14, 2030

    in 3 yr 11 mo

  13. Patent 12115179*PED expires

    Listed listed patent expiration.

    Aug 11, 2030

    in 4 yr 2 mo

  14. Patent 12527810 expires

    Listed method-of-use patent (U-4403) expiration.

    Apr 22, 2033

    in 6 yr 11 mo

  15. Patent 12527810*PED expires

    Listed listed patent expiration.

    Oct 22, 2033

    in 7 yr 5 mo

  16. Patent 10258637 expires

    Listed method-of-use patent (U-2290) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  17. Patent 11090323 expires

    Listed method-of-use patent (U-3191) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  18. Patent 11666590 expires

    Listed method-of-use patent (U-3691) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  19. Patent 11813275 expires

    Listed method-of-use patent (U-3759) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  20. Patent 11813275 expires

    Listed method-of-use patent (U-3760) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  21. Patent 11833166 expires

    Listed method-of-use patent (U-3776) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  22. Patent 11833166 expires

    Listed method-of-use patent (U-3777) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  23. Patent 12263153 expires

    Listed method-of-use patent (U-4171) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  24. Patent 12427162 expires

    Listed method-of-use patent (U-4287) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  25. Patent 12433906 expires

    Listed method-of-use patent (U-4304) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  26. Patent 12433906 expires

    Listed method-of-use patent (U-4293) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  27. Patent 12433906 expires

    Listed method-of-use patent (U-4294) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  28. Patent 12433906 expires

    Listed method-of-use patent (U-4295) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  29. Patent 12433906 expires

    Listed method-of-use patent (U-4296) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  30. Patent 9949997 expires

    Listed method-of-use patent (U-2292) expiration.

    May 17, 2034

    in 8 yr

  31. Patent 9949997 expires

    Listed method-of-use patent (U-3325) expiration.

    May 17, 2034

    in 8 yr

  32. Patent 9949997 expires

    Listed method-of-use patent (U-3199) expiration.

    May 17, 2034

    in 8 yr

  33. Patent 9949998 expires

    Listed method-of-use patent (U-2290) expiration.

    Jun 11, 2034

    in 8 yr 1 mo

  34. Patent 10258637*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  35. Patent 11090323*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  36. Patent 11813275*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  37. Patent 11833166*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  38. Patent 12433906*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  39. Patent 9949997*PED expires

    Listed listed patent expiration.

    Nov 17, 2034

    in 8 yr 6 mo

  40. Patent 9949998*PED expires

    Listed listed patent expiration.

    Dec 11, 2034

    in 8 yr 7 mo

Pharmaceutical detail

Active ingredient

EMPAGLIFLOZIN

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 204629

Product number

001

Marketing status

RX

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.

Marketing exclusivity (3)

  • NPPNew patient population exclusivity (3 years)

    Jun 20, 2026

    in 1 d

  • I-922New indication exclusivity (3 years)

    Sep 21, 2026

    in 3 mo

  • PEDPediatric exclusivity (adds 6 months)

    Dec 20, 2026

    in 6 mo

Listed patents (35)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7713938Apr 15, 2027in 10 mo
SubstanceProduct
7713938*PEDOct 15, 2027in 1 yr 4 mo
7579449Aug 01, 2028in 2 yr 2 mo
Substance
7579449*PEDFeb 01, 2029in 2 yr 8 mo
8551957Oct 14, 2029in 3 yr 4 mo
U-1651
12115179Feb 11, 2030in 3 yr 8 mo
U-4023
8551957*PEDApr 14, 2030in 3 yr 11 mo
12115179*PEDAug 11, 2030in 4 yr 2 mo
12527810Apr 22, 2033in 6 yr 11 mo
U-4403
12527810*PEDOct 22, 2033in 7 yr 5 mo
10258637Apr 03, 2034in 7 yr 11 mo
U-2290
11090323Apr 03, 2034in 7 yr 11 mo
U-3191
11666590Apr 03, 2034in 7 yr 11 mo
U-3691
11813275Apr 03, 2034in 7 yr 11 mo
U-3759
11813275Apr 03, 2034in 7 yr 11 mo
U-3760
11833166Apr 03, 2034in 7 yr 11 mo
U-3776
11833166Apr 03, 2034in 7 yr 11 mo
U-3777
12263153Apr 03, 2034in 7 yr 11 mo
U-4171
12427162Apr 03, 2034in 7 yr 11 mo
U-4287
12433906Apr 03, 2034in 7 yr 11 mo
U-4304
12433906Apr 03, 2034in 7 yr 11 mo
U-4293
12433906Apr 03, 2034in 7 yr 11 mo
U-4294
12433906Apr 03, 2034in 7 yr 11 mo
U-4295
12433906Apr 03, 2034in 7 yr 11 mo
U-4296
9949997May 17, 2034in 8 yr
U-2292
9949997May 17, 2034in 8 yr
U-3325
9949997May 17, 2034in 8 yr
U-3199
9949998Jun 11, 2034in 8 yr 1 mo
U-2290
10258637*PEDOct 03, 2034in 8 yr 5 mo
11090323*PEDOct 03, 2034in 8 yr 5 mo
11813275*PEDOct 03, 2034in 8 yr 5 mo
11833166*PEDOct 03, 2034in 8 yr 5 mo
12433906*PEDOct 03, 2034in 8 yr 5 mo
9949997*PEDNov 17, 2034in 8 yr 6 mo
9949998*PEDDec 11, 2034in 8 yr 7 mo
Agent CTA Background

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