Assyro AI

Orange Book product · Brand (NDA)

FARXIGA

DAPAGLIFLOZIN

Brand (NDA)NDA 202293TE ABRX ASTRAZENECA AB
View DAPAGLIFLOZIN familyOpen on FDA Orange Book

At a glance

Jan 08, 2014

Approved

Brand (NDA)

Application

AB

TE code

26

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 08, 2014

    12 yr 8 mo ago

  2. Patent 6515117 expires

    Listed drug substance patent expiration.

    Oct 04, 2025

    9 mo ago

  3. Patent 6515117 expires

    Listed drug substance patent expiration.

    Oct 04, 2025

    9 mo ago

  4. Patent 6515117*PED expires

    Listed listed patent expiration.

    Apr 04, 2026

    3 mo ago

  5. Exclusivity ends · M-298

    New use / labeling-change exclusivity (3 years)

    May 08, 2026

    1 mo ago

  6. Today

  7. Patent 8329648 expires

    Listed method-of-use patent (U-2213) expiration.

    Aug 18, 2026

    in 2 mo

  8. Patent 8329648 expires

    Listed method-of-use patent (U-2139) expiration.

    Aug 18, 2026

    in 2 mo

  9. Patent 8329648 expires

    Listed method-of-use patent (U-2212) expiration.

    Aug 18, 2026

    in 2 mo

  10. Patent 8906851 expires

    Listed method-of-use patent (U-2139) expiration.

    Aug 18, 2026

    in 2 mo

  11. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 08, 2026

    in 5 mo

  12. Patent 8329648*PED expires

    Listed listed patent expiration.

    Feb 18, 2027

    in 8 mo

  13. Patent 8906851*PED expires

    Listed listed patent expiration.

    Feb 18, 2027

    in 8 mo

  14. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    Jun 12, 2027

    in 1 yr

  15. Patent 8501698 expires

    Listed drug product patent expiration.

    Jun 20, 2027

    in 1 yr

  16. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Dec 12, 2027

    in 1 yr 6 mo

  17. Patent 8501698*PED expires

    Listed listed patent expiration.

    Dec 20, 2027

    in 1 yr 6 mo

  18. Patent 8221786 expires

    Listed drug product patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  19. Patent 8361972 expires

    Listed method-of-use patent (U-2139) expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  20. Patent 8361972 expires

    Listed method-of-use patent (U-493) expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  21. Patent 8716251 expires

    Listed drug product patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  22. Patent 7851502 expires

    Listed drug product patent expiration.

    Aug 19, 2028

    in 2 yr 2 mo

  23. Patent 8221786*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  24. Patent 8361972*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  25. Patent 8716251*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  26. Patent 7851502*PED expires

    Listed listed patent expiration.

    Feb 19, 2029

    in 2 yr 9 mo

  27. Patent 7919598 expires

    Listed drug substance patent expiration.

    Dec 16, 2029

    in 3 yr 7 mo

  28. Patent 8721615 expires

    Listed drug product patent expiration.

    Jan 18, 2030

    in 3 yr 8 mo

  29. Patent 8685934 expires

    Listed method-of-use patent (U-1522) expiration.

    May 26, 2030

    in 4 yr

  30. Patent 7919598*PED expires

    Listed listed patent expiration.

    Jun 16, 2030

    in 4 yr 1 mo

  31. Patent 8721615*PED expires

    Listed listed patent expiration.

    Jul 18, 2030

    in 4 yr 2 mo

  32. Patent 8685934*PED expires

    Listed listed patent expiration.

    Nov 26, 2030

    in 4 yr 6 mo

Pharmaceutical detail

Active ingredient

DAPAGLIFLOZIN

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 202293

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 (4)

  • M-298New use / labeling-change exclusivity (3 years)

    May 08, 2026

    1 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Nov 08, 2026

    in 5 mo

  • NPPNew patient population exclusivity (3 years)

    Jun 12, 2027

    in 1 yr

  • PEDPediatric exclusivity (adds 6 months)

    Dec 12, 2027

    in 1 yr 6 mo

Listed patents (26)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
6515117Oct 04, 20259 mo ago
SubstanceProductU-493
6515117Oct 04, 20259 mo ago
SubstanceProductU-2139
6515117*PEDApr 04, 20263 mo ago
8329648Aug 18, 2026in 2 mo
U-2213
8329648Aug 18, 2026in 2 mo
U-2139
8329648Aug 18, 2026in 2 mo
U-2212
8906851Aug 18, 2026in 2 mo
U-2139
8329648*PEDFeb 18, 2027in 8 mo
8906851*PEDFeb 18, 2027in 8 mo
8501698Jun 20, 2027in 1 yr
ProductU-493
8501698*PEDDec 20, 2027in 1 yr 6 mo
8221786Mar 21, 2028in 1 yr 9 mo
Product
8361972Mar 21, 2028in 1 yr 9 mo
U-2139
8361972Mar 21, 2028in 1 yr 9 mo
U-493
8716251Mar 21, 2028in 1 yr 9 mo
Product
7851502Aug 19, 2028in 2 yr 2 mo
Product
8221786*PEDSep 21, 2028in 2 yr 4 mo
8361972*PEDSep 21, 2028in 2 yr 4 mo
8716251*PEDSep 21, 2028in 2 yr 4 mo
7851502*PEDFeb 19, 2029in 2 yr 9 mo
7919598Dec 16, 2029in 3 yr 7 mo
Substance
8721615Jan 18, 2030in 3 yr 8 mo
ProductDelisted
8685934May 26, 2030in 4 yr
U-1522
7919598*PEDJun 16, 2030in 4 yr 1 mo
8721615*PEDJul 18, 2030in 4 yr 2 mo
8685934*PEDNov 26, 2030in 4 yr 6 mo
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