ribociclib succinate · Novartis · NDA 209092
Kisqali
Earliest generic entry, as listed
14 Oct 2036
Blocked by patent: US 10799506, US 12064434, US 12419894.
Listed patents · 43 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10799506 | — | 14 Oct 2036 |
| US 12064434 | — | 14 Oct 2036 |
| US 12419894 | — | 14 Oct 2036 |
| US 10799506 | product | 14 Apr 2036 |
| US 12064434 | product | 14 Apr 2036 |
| US 12419894 | product | 14 Apr 2036 |
| US 12544379 | — | 7 Feb 2035 |
| US 12544380 | — | 7 Feb 2035 |
| US 12544379 | use U-3975 | 7 Aug 2034 |
| US 12544380 | use U-4405 | 7 Aug 2034 |
| US 12544380 | use U-4404 | 7 Aug 2034 |
| US 9193732 | — | 9 May 2032 |
| US 9868739 | — | 9 May 2032 |
| US 9193732 | substance, product | 9 Nov 2031 |
| US 9868739 | use U-3266 | 9 Nov 2031 |
| US 9868739 | use U-2355 | 9 Nov 2031 |
| US 9868739 | use U-2356 | 9 Nov 2031 |
| US 9868739 | use U-3999 | 9 Nov 2031 |
| US 9868739 | use U-1981 | 9 Nov 2031 |
| US 9868739 | use U-3975 | 9 Nov 2031 |
| US 9868739 | use U-3265 | 9 Nov 2031 |
| US 8415355 | — | 13 Sep 2031 |
| US 8415355 | substance, product | 13 Mar 2031 |
| US 8685980 | — | 25 Nov 2030 |
| US 8962630 | — | 9 Jun 2030 |
| US 8685980 | substance, product | 25 May 2030 |
| US 9416136 | — | 20 Feb 2030 |
| US 8962630 | use U-2356 | 9 Dec 2029 |
| US 8962630 | use U-3975 | 9 Dec 2029 |
| US 8962630 | use U-3266 | 9 Dec 2029 |
| US 8962630 | use U-3265 | 9 Dec 2029 |
| US 8962630 | use U-3999 | 9 Dec 2029 |
| US 8962630 | use U-2355 | 9 Dec 2029 |
| US 8962630 | use U-1981 | 9 Dec 2029 |
| US 9416136 | use U-3265 | 20 Aug 2029 |
| US 9416136 | use U-2355 | 20 Aug 2029 |
| US 9416136 | use U-3975 | 20 Aug 2029 |
| US 9416136 | use U-3999 | 20 Aug 2029 |
| US 9416136 | use U-1981 | 20 Aug 2029 |
| US 9416136 | use U-2356 | 20 Aug 2029 |
| US 9416136 | use U-3266 | 20 Aug 2029 |
| US 8324225 | — | 17 Dec 2028 |
| US 8324225 | substance, product | 17 Jun 2028 |
Exclusivities · 4 unexpired
| PED | pediatric (6 months added) | 1 Jan 2030 |
| M-14 | miscellaneous (3 years) | 1 Jul 2029 |
| PED | pediatric (6 months added) | 17 Mar 2028 |
| I-950 | new indication (3 years) | 17 Sep 2027 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209092 · 001 · RLD | tablet, oral | EQ 200MG BASE | 14 Oct 2036 |