FDA Orange Book · active-ingredient family
Empagliflozin; linagliptin; metformin hydrochloride
Empagliflozin; linagliptin; metformin hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TRIJARDY XR · NDA 212614
1
Brand (NDA)
0
Generics (ANDA)
26
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIJARDY XRRLD×4 | BOEHRINGER INGELHEIM | NDA 212614 | — | Jan 27, 2020 |
Listed patents (26)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8883805 | Nov 26, 2025 | 7 mo ago | Product |
| 8883805*PED | May 26, 2026 | 24 d ago | |
| 7713938 | Apr 15, 2027 | in 10 mo | SubstanceProduct |
| 7713938*PED | Oct 15, 2027 | in 1 yr 4 mo | |
| 7579449 | Aug 01, 2028 | in 2 yr 2 mo | Substance |
| 7579449*PED | Feb 01, 2029 | in 2 yr 8 mo | |
| 10022379 | Apr 02, 2029 | in 2 yr 10 mo | ProductU-2732 |
| 9415016 | Apr 02, 2029 | in 2 yr 10 mo | Product |
| 8551957 | Oct 14, 2029 | in 3 yr 4 mo | ProductU-2730 |
| 12115179 | Feb 11, 2030 | in 3 yr 8 mo | U-4023 |
| 8551957*PED | Apr 14, 2030 | in 3 yr 11 mo | |
| 9155705 | May 21, 2030 | in 4 yr | Product |
| 10406172 | Jun 15, 2030 | in 4 yr 1 mo | ProductU-2733 |
| 12115179*PED | Aug 11, 2030 | in 4 yr 2 mo | |
| 11564886 | Mar 07, 2032 | in 5 yr 10 mo | ProductU-3531 |
| 10596120 | Mar 07, 2032 | in 5 yr 10 mo | ProductU-2790 |
| 10258637 | Apr 03, 2034 | in 7 yr 11 mo | U-2731 |
| 11090323 | Apr 03, 2034 | in 7 yr 11 mo | U-3192 |
| 11833166 | Apr 03, 2034 | in 7 yr 11 mo | U-3776 |
| 9949998 | Jun 11, 2034 | in 8 yr 1 mo | U-2731 |
| 10258637*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 11833166*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 11090323*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 9949998*PED | Dec 11, 2034 | in 8 yr 7 mo | |
| 12364700 | Jun 08, 2037 | in 11 yr 2 mo | U-4224 |
| 12364700*PED | Dec 08, 2037 | in 11 yr 8 mo |
Empagliflozin; linagliptin; metformin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
