linagliptin; metformin hydrochloride · Boehringer Ingelheim · NDA 208026
Jentadueto Xr
Earliest generic entry, as listed · earliest of 2 marketed strengths
8 Dec 2037
Blocked by patent: US 12364700.
Listed patents · 15 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12364700 | — | 8 Dec 2037 |
| US 12364700 | use U-4224 | 8 Jun 2037 |
| US 9555001 | — | 6 Sep 2033 |
| US 9555001 | product, use U-1967 | 6 Mar 2033 |
| US 9555001 | product, use U-1968 | 6 Mar 2033 |
| US 9155705 | — | 21 Nov 2030 |
| US 9155705 | product | 21 May 2030 |
| US 11911388 | use U-3854 | 10 Apr 2030 |
| US 10022379 | — | 2 Oct 2029 |
| US 9415016 | — | 2 Oct 2029 |
| US 10022379 | use U-2339 | 2 Apr 2029 |
| US 12678442 | product | 2 Apr 2029 |
| US 9415016 | product | 2 Apr 2029 |
| US 8673927 | — | 4 Nov 2027 |
| US 9173859 | — | 4 Nov 2027 |
Exclusivities · 1 unexpired
| PED | pediatric (6 months added) | 20 Dec 2026 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 24 Oct 2026Exclusivity expires within 90 days PED · 208026-00220 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 208026-00120 Dec 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208026 · 001 · RLD | tablet, extended release, oral | 2.5MG;1GM | 8 Dec 2037 |
| 208026 · 002 · RLD | tablet, extended release, oral | 5MG;1GM | 8 Dec 2037 |
Expired or delisted (5)
- US 8673927 · use U-1503 · 4 May 2027 · delisted
- US 9173859 · product, use U-1503 · 4 May 2027 · delisted
- US 8883805 · — · 26 May 2026
- US 8883805 · product · 26 Nov 2025
- M-295 · 20 Jun 2026