linagliptin · Boehringer Ingelheim · NDA 201280
Tradjenta
Earliest generic entry, as listed
8 Dec 2037
Blocked by patent: US 12364700.
FDA has approved 5 generic applications (ANDAs) for Tradjenta, though its earliest generic-entry date is 8 Dec 2037 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12364700 | — | 8 Dec 2037 |
| US 12364700 | use U-4224 | 8 Jun 2037 |
| US 8853156 | — | 5 Sep 2031 |
| US 8853156 | product, use U-1642 | 5 Mar 2031 |
| US 8846695 | — | 4 Dec 2030 |
| US 11911388 | use U-3854 | 10 Apr 2030 |
| US 10034877 | — | 5 Feb 2030 |
| US 9486526 | — | 5 Feb 2030 |
| US 10034877 | use U-2347 | 5 Aug 2029 |
| US 9486526 | use U-1915 | 5 Aug 2029 |
| US 11033552 | — | 4 Nov 2027 |
| US 8673927 | — | 4 Nov 2027 |
| US 11033552 | product | 4 May 2027 |
| US 12178819 | product | 4 May 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 · 201280-0013 Nov 2025
- 25 Oct 2026Generic approved · 201280-0013 Nov 2025
- 25 Oct 2026Generic approved · 201280-00127 May 2026
- 25 Oct 2026Generic approved · 201280-0013 Nov 2025
- 25 Oct 2026Generic approved · 201280-0013 Nov 2025
- 24 Oct 2026Exclusivity expires within 90 days PED · 201280-00120 Dec 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201280 · 001 · RLD | tablet, oral | 5MG | 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