carfilzomib · Onyx Pharms Amgen · NDA 202714
Kyprolis
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Oct 2041
Blocked by patent: US 12636340.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12636340 | — | 29 Oct 2041 |
| US 12636340 | use U-4551 | 29 Apr 2041 |
| US 9493582 | — | 27 Aug 2033 |
| US 9493582 | product | 27 Feb 2033 |
| US RE47954 | — | 21 Apr 2030 |
| US RE47954 | use U-3449 | 21 Oct 2029 |
| US 7737112 | — | 7 Jun 2028 |
| US 7737112 | product | 7 Dec 2027 |
| US 7417042 | — | 20 Jan 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 22 Nov 2028 |
| M-14 | miscellaneous (3 years) | 22 May 2028 |
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 tentatively approved · 202714-0017 Nov 2025
- 25 Oct 2026Generic approved · 202714-00120 Jul 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202714 · 001 · RLD | powder, intravenous | 60MG/VIAL | 29 Oct 2041 |
| 202714 · 002 · RLD | powder, intravenous | 30MG/VIAL | 29 Oct 2041 |
| 202714 · 003 · RLD | powder, intravenous | 10MG/VIAL | 29 Oct 2041 |
Expired or delisted (1)
- US 7417042 · substance, product · 20 Jul 2026