Assyro AI

Orange Book product · Brand (NDA)

GLYXAMBI

EMPAGLIFLOZIN; LINAGLIPTIN

Brand (NDA)NDA 206073RX BOEHRINGER INGELHEIM
View EMPAGLIFLOZIN; LINAGLIPTIN familyOpen on FDA Orange Book

At a glance

Jan 30, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

32

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 2015

    11 yr 7 mo ago

  2. Patent 8883805 expires

    Listed drug product patent expiration.

    Nov 26, 2025

    7 mo ago

  3. Patent 8883805*PED expires

    Listed listed patent expiration.

    May 26, 2026

    24 d ago

  4. Today

  5. Patent 7713938 expires

    Listed drug substance patent expiration.

    Apr 15, 2027

    in 10 mo

  6. Patent 11033552 expires

    Listed drug product patent expiration.

    May 04, 2027

    in 11 mo

  7. Patent 12178819 expires

    Listed drug product patent expiration.

    May 04, 2027

    in 11 mo

  8. Patent 8673927 expires

    Listed method-of-use patent (U-1652) expiration.

    May 04, 2027

    in 11 mo

  9. Patent 9173859 expires

    Listed drug product patent expiration.

    May 04, 2027

    in 11 mo

  10. Patent 7713938*PED expires

    Listed listed patent expiration.

    Oct 15, 2027

    in 1 yr 4 mo

  11. Patent 11033552*PED expires

    Listed listed patent expiration.

    Nov 04, 2027

    in 1 yr 5 mo

  12. Patent 8673927*PED expires

    Listed listed patent expiration.

    Nov 04, 2027

    in 1 yr 5 mo

  13. Patent 7579449 expires

    Listed drug substance patent expiration.

    Aug 01, 2028

    in 2 yr 2 mo

  14. Patent 7579449*PED expires

    Listed listed patent expiration.

    Feb 01, 2029

    in 2 yr 8 mo

  15. Patent 8551957 expires

    Listed drug product patent expiration.

    Oct 14, 2029

    in 3 yr 4 mo

  16. Patent 12115179 expires

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

    Feb 11, 2030

    in 3 yr 8 mo

  17. Patent 8551957*PED expires

    Listed listed patent expiration.

    Apr 14, 2030

    in 3 yr 11 mo

  18. Patent 12115179*PED expires

    Listed listed patent expiration.

    Aug 11, 2030

    in 4 yr 2 mo

  19. Patent 10258637 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  20. Patent 11090323 expires

    Listed method-of-use patent (U-3191) 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 12433906 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  24. Patent 12433906 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  25. Patent 12433906 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  26. Patent 12433906 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  27. Patent 12433906 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  28. Patent 9949998 expires

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

    Jun 11, 2034

    in 8 yr 1 mo

  29. Patent 10258637*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  30. Patent 11090323*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  31. Patent 11833166*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  32. Patent 12433906*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  33. Patent 12364700 expires

    Listed method-of-use patent (U-4224) expiration.

    Jun 08, 2037

    in 11 yr 2 mo

  34. Patent 12364700*PED expires

    Listed listed patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

Pharmaceutical detail

Active ingredient

EMPAGLIFLOZIN; LINAGLIPTIN

Strength

10MG;5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 206073

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.

Listed patents (32)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8883805Nov 26, 20257 mo ago
Product
8883805*PEDMay 26, 202624 d ago
7713938Apr 15, 2027in 10 mo
SubstanceProduct
11033552May 04, 2027in 11 mo
Product
12178819May 04, 2027in 11 mo
Product
8673927May 04, 2027in 11 mo
U-1652Delisted
9173859May 04, 2027in 11 mo
ProductU-1772Delisted
7713938*PEDOct 15, 2027in 1 yr 4 mo
11033552*PEDNov 04, 2027in 1 yr 5 mo
8673927*PEDNov 04, 2027in 1 yr 5 mo
7579449Aug 01, 2028in 2 yr 2 mo
Substance
7579449*PEDFeb 01, 2029in 2 yr 8 mo
8551957Oct 14, 2029in 3 yr 4 mo
ProductU-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
10258637Apr 03, 2034in 7 yr 11 mo
U-2290
11090323Apr 03, 2034in 7 yr 11 mo
U-3191
11833166Apr 03, 2034in 7 yr 11 mo
U-3776
11833166Apr 03, 2034in 7 yr 11 mo
U-3777
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
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
11833166*PEDOct 03, 2034in 8 yr 5 mo
12433906*PEDOct 03, 2034in 8 yr 5 mo
12364700Jun 08, 2037in 11 yr 2 mo
U-4224
12364700*PEDDec 08, 2037in 11 yr 8 mo
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