cangrelor · Chiesi · NDA 204958
Kengreal
Earliest generic entry, as listed
10 Jul 2035
Blocked by patent: US 10039780, US 9295687, US 9439921, US 9700575.
FDA has approved 1 generic application (ANDA) for Kengreal, though its earliest generic-entry date is 10 Jul 2035 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 · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10039780 | use U-2260 · sets the listed date | 10 Jul 2035 |
| US 9295687 | drug product · sets the listed date | 10 Jul 2035 |
| US 9439921 | drug product · sets the listed date | 10 Jul 2035 |
| US 9700575 | drug product · sets the listed date | 10 Jul 2035 |
| US 8680052 | use U-2979 | 9 Mar 2033 |
| US 9427448 | use U-1926 | 10 Nov 2030 |
| US 9925265 | use U-2260 | 13 May 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 204958-0014 Jun 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204958 · 001 · RLD | powder, intravenous | 50MG/VIAL | 10 Jul 2035 |