cliffwatch

ribociclib succinate · Novartis · NDA 209092

Kisqali

Earliest generic entry, as listed
14 Oct 2036

Blocked by patent: US 10799506 (pediatric extension), US 12064434 (pediatric extension), US 12419894 (pediatric extension).

Listed patents · 12 unexpired

43 Orange Book listing rows for 12 patents, including 12 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10799506drug product14 Oct 2036
US 10799506 listing rowdrug product14 Apr 2036
US 10799506 listing rowpediatric extension · sets the listed date14 Oct 2036
US 12064434drug product14 Oct 2036
US 12064434 listing rowdrug product14 Apr 2036
US 12064434 listing rowpediatric extension · sets the listed date14 Oct 2036
US 12419894drug product14 Oct 2036
US 12419894 listing rowdrug product14 Apr 2036
US 12419894 listing rowpediatric extension · sets the listed date14 Oct 2036
US 12544379use U-39757 Feb 2035
US 12544379 listing rowuse U-39757 Aug 2034
US 12544379 listing rowpediatric extension7 Feb 2035
US 12544380use U-4404, U-44057 Feb 2035
US 12544380 listing rowuse U-44047 Aug 2034
US 12544380 listing rowuse U-44057 Aug 2034
US 12544380 listing rowpediatric extension7 Feb 2035
US 9193732drug substance, drug product9 May 2032
US 9193732 listing rowdrug substance, drug product9 Nov 2031
US 9193732 listing rowpediatric extension9 May 2032
US 9868739use U-1981, U-2355, U-2356, U-3265, U-3266, U-3975, U-39999 May 2032
US 9868739 listing rowuse U-19819 Nov 2031
US 9868739 listing rowuse U-23559 Nov 2031
US 9868739 listing rowuse U-23569 Nov 2031
US 9868739 listing rowuse U-32659 Nov 2031
US 9868739 listing rowuse U-32669 Nov 2031
US 9868739 listing rowuse U-39759 Nov 2031
US 9868739 listing rowuse U-39999 Nov 2031
US 9868739 listing rowpediatric extension9 May 2032
US 8415355drug substance, drug product13 Sep 2031
US 8415355 listing rowdrug substance, drug product13 Mar 2031
US 8415355 listing rowpediatric extension13 Sep 2031
US 8685980drug substance, drug product25 Nov 2030
US 8685980 listing rowdrug substance, drug product25 May 2030
US 8685980 listing rowpediatric extension25 Nov 2030
US 8962630use U-1981, U-2355, U-2356, U-3265, U-3266, U-3975, U-39999 Jun 2030
US 8962630 listing rowuse U-19819 Dec 2029
US 8962630 listing rowuse U-23559 Dec 2029
US 8962630 listing rowuse U-23569 Dec 2029
US 8962630 listing rowuse U-32659 Dec 2029
US 8962630 listing rowuse U-32669 Dec 2029
US 8962630 listing rowuse U-39759 Dec 2029
US 8962630 listing rowuse U-39999 Dec 2029
US 8962630 listing rowpediatric extension9 Jun 2030
US 9416136use U-1981, U-2355, U-2356, U-3265, U-3266, U-3975, U-399920 Feb 2030
US 9416136 listing rowuse U-198120 Aug 2029
US 9416136 listing rowuse U-235520 Aug 2029
US 9416136 listing rowuse U-235620 Aug 2029
US 9416136 listing rowuse U-326520 Aug 2029
US 9416136 listing rowuse U-326620 Aug 2029
US 9416136 listing rowuse U-397520 Aug 2029
US 9416136 listing rowuse U-399920 Aug 2029
US 9416136 listing rowpediatric extension20 Feb 2030
US 8324225drug substance, drug product17 Dec 2028
US 8324225 listing rowdrug substance, drug product17 Jun 2028
US 8324225 listing rowpediatric extension17 Dec 2028

Exclusivities · 3 unexpired

PEDpediatric (6 months added)1 Jan 2030
M-14miscellaneous (3 years)1 Jul 2029
PEDpediatric (6 months added)17 Mar 2028
I-950new 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 · productFormStrengthListed expiry
209092 · 001 · RLDtablet, oralEQ 200MG BASE14 Oct 2036