Assyro AI

Orange Book product · Brand (NDA)

TRIJARDY XR

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand (NDA)NDA 212614RX BOEHRINGER INGELHEIM
View EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jan 27, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

28

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 27, 2020

    6 yr 6 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 7713938*PED expires

    Listed listed patent expiration.

    Oct 15, 2027

    in 1 yr 4 mo

  7. Patent 7579449 expires

    Listed drug substance patent expiration.

    Aug 01, 2028

    in 2 yr 2 mo

  8. Patent 7579449*PED expires

    Listed listed patent expiration.

    Feb 01, 2029

    in 2 yr 8 mo

  9. Patent 10022379 expires

    Listed drug product patent expiration.

    Apr 02, 2029

    in 2 yr 10 mo

  10. Patent 9415016 expires

    Listed drug product patent expiration.

    Apr 02, 2029

    in 2 yr 10 mo

  11. Patent 8551957 expires

    Listed drug product patent expiration.

    Oct 14, 2029

    in 3 yr 4 mo

  12. Patent 12115179 expires

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

    Feb 11, 2030

    in 3 yr 8 mo

  13. Patent 8551957*PED expires

    Listed listed patent expiration.

    Apr 14, 2030

    in 3 yr 11 mo

  14. Patent 9155705 expires

    Listed drug product patent expiration.

    May 21, 2030

    in 4 yr

  15. Patent 10406172 expires

    Listed drug product patent expiration.

    Jun 15, 2030

    in 4 yr 1 mo

  16. Patent 12115179*PED expires

    Listed listed patent expiration.

    Aug 11, 2030

    in 4 yr 2 mo

  17. Patent 10596120 expires

    Listed drug product patent expiration.

    Mar 07, 2032

    in 5 yr 10 mo

  18. Patent 10596120 expires

    Listed drug product patent expiration.

    Mar 07, 2032

    in 5 yr 10 mo

  19. Patent 11564886 expires

    Listed drug product patent expiration.

    Mar 07, 2032

    in 5 yr 10 mo

  20. Patent 10258637 expires

    Listed method-of-use patent (U-2731) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  21. Patent 11090323 expires

    Listed method-of-use patent (U-3192) expiration.

    Apr 03, 2034

    in 7 yr 11 mo

  22. Patent 11833166 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  23. Patent 11833166 expires

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

    Apr 03, 2034

    in 7 yr 11 mo

  24. Patent 9949998 expires

    Listed method-of-use patent (U-2731) expiration.

    Jun 11, 2034

    in 8 yr 1 mo

  25. Patent 10258637*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  26. Patent 11090323*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  27. Patent 11833166*PED expires

    Listed listed patent expiration.

    Oct 03, 2034

    in 8 yr 5 mo

  28. Patent 9949998*PED expires

    Listed listed patent expiration.

    Dec 11, 2034

    in 8 yr 7 mo

  29. Patent 12364700 expires

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

    Jun 08, 2037

    in 11 yr 2 mo

  30. Patent 12364700*PED expires

    Listed listed patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

Pharmaceutical detail

Active ingredient

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Strength

5MG;2.5MG;1GM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 212614

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 (28)

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
7713938*PEDOct 15, 2027in 1 yr 4 mo
7579449Aug 01, 2028in 2 yr 2 mo
Substance
7579449*PEDFeb 01, 2029in 2 yr 8 mo
10022379Apr 02, 2029in 2 yr 10 mo
ProductU-2732
9415016Apr 02, 2029in 2 yr 10 mo
Product
8551957Oct 14, 2029in 3 yr 4 mo
ProductU-2730
12115179Feb 11, 2030in 3 yr 8 mo
U-4023
8551957*PEDApr 14, 2030in 3 yr 11 mo
9155705May 21, 2030in 4 yr
Product
10406172Jun 15, 2030in 4 yr 1 mo
ProductU-2733
12115179*PEDAug 11, 2030in 4 yr 2 mo
10596120Mar 07, 2032in 5 yr 10 mo
ProductU-2790
10596120Mar 07, 2032in 5 yr 10 mo
ProductU-2776
11564886Mar 07, 2032in 5 yr 10 mo
ProductU-3531
10258637Apr 03, 2034in 7 yr 11 mo
U-2731
11090323Apr 03, 2034in 7 yr 11 mo
U-3192
11833166Apr 03, 2034in 7 yr 11 mo
U-3776
11833166Apr 03, 2034in 7 yr 11 mo
U-3777
9949998Jun 11, 2034in 8 yr 1 mo
U-2731
10258637*PEDOct 03, 2034in 8 yr 5 mo
11090323*PEDOct 03, 2034in 8 yr 5 mo
11833166*PEDOct 03, 2034in 8 yr 5 mo
9949998*PEDDec 11, 2034in 8 yr 7 mo
12364700Jun 08, 2037in 11 yr 2 mo
U-4224
12364700*PEDDec 08, 2037in 11 yr 8 mo
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