linagliptin; metformin hydrochloride · Boehringer Ingelheim · NDA 201281
Jentadueto
Earliest generic entry, as listed · earliest of 3 marketed strengths
8 Dec 2037
Blocked by patent: US 12364700.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12364700 | — | 8 Dec 2037 |
| US 12364700 | use U-4224 | 8 Jun 2037 |
| US 8846695 | — | 4 Dec 2030 |
| 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 10973827 | — | 2 Oct 2029 |
| US 9415016 | — | 2 Oct 2029 |
| US 10022379 | use U-2339 | 2 Apr 2029 |
| US 10973827 | product | 2 Apr 2029 |
| US 12678442 | product | 2 Apr 2029 |
| US 9415016 | product | 2 Apr 2029 |
| US 8673927 | — | 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
- 25 Oct 2026Generic approved · 201281-0013 Nov 2025
- 25 Oct 2026Generic approved · 201281-0013 Nov 2025
- 24 Oct 2026Exclusivity expires within 90 days PED · 201281-00220 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 201281-00120 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 201281-00320 Dec 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201281 · 001 · RLD | tablet, oral | 2.5MG;500MG | 8 Dec 2037 |
| 201281 · 002 · RLD | tablet, oral | 2.5MG;850MG | 8 Dec 2037 |
| 201281 · 003 · RLD | tablet, oral | 2.5MG;1GM | 8 Dec 2037 |
Expired or delisted (5)
- US 8846695 · use U-1503 · 4 Jun 2030 · delisted
- US 8673927 · use U-1503 · 4 May 2027 · delisted
- US 8883805 · — · 26 May 2026
- US 8883805 · product · 26 Nov 2025
- M-295 · 20 Jun 2026