letrozole; ribociclib succinate · Novartis · NDA 209935

Kisqali Femara Co-Pack (Copackaged)

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 · 11 unexpired

29 Orange Book listing rows for 11 patents, including 11 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 10799506	drug product	14 Oct 2036	2 listing rows
US 10799506 listing row	drug product	14 Apr 2036	listed 6 Nov 2020
US 10799506 listing row	pediatric extension · sets the listed date	14 Oct 2036
US 12064434	drug product	14 Oct 2036	2 listing rows
US 12064434 listing row	drug product	14 Apr 2036	listed 13 Sep 2024
US 12064434 listing row	pediatric extension · sets the listed date	14 Oct 2036
US 12419894	drug product	14 Oct 2036	2 listing rows
US 12419894 listing row	drug product	14 Apr 2036	listed 2 Oct 2025
US 12419894 listing row	pediatric extension · sets the listed date	14 Oct 2036
US 12544380	use U-3264, U-3998	7 Feb 2035	3 listing rows
US 12544380 listing row	use U-3264	7 Aug 2034	listed 10 Feb 2026
US 12544380 listing row	use U-3998	7 Aug 2034	listed 10 Feb 2026
US 12544380 listing row	pediatric extension	7 Feb 2035
US 9193732	drug substance, drug product	9 May 2032	2 listing rows
US 9193732 listing row	drug substance, drug product	9 Nov 2031	listed 19 May 2017
US 9193732 listing row	pediatric extension	9 May 2032
US 9868739	use U-2505, U-3264, U-3998	9 May 2032	4 listing rows
US 9868739 listing row	use U-2505	9 Nov 2031	listed 5 Jun 2018
US 9868739 listing row	use U-3264	9 Nov 2031	listed 5 Jun 2018
US 9868739 listing row	use U-3998	9 Nov 2031	listed 5 Jun 2018
US 9868739 listing row	pediatric extension	9 May 2032
US 8415355	drug substance, drug product	13 Sep 2031	2 listing rows
US 8415355 listing row	drug substance, drug product	13 Mar 2031	listed 19 May 2017
US 8415355 listing row	pediatric extension	13 Sep 2031
US 8685980	drug substance, drug product	25 Nov 2030	2 listing rows
US 8685980 listing row	drug substance, drug product	25 May 2030	listed 19 May 2017
US 8685980 listing row	pediatric extension	25 Nov 2030
US 8962630	use U-2505, U-3264, U-3998	9 Jun 2030	4 listing rows
US 8962630 listing row	use U-2505	9 Dec 2029	listed 19 May 2017
US 8962630 listing row	use U-3264	9 Dec 2029	listed 19 May 2017
US 8962630 listing row	use U-3998	9 Dec 2029	listed 19 May 2017
US 8962630 listing row	pediatric extension	9 Jun 2030
US 9416136	use U-2505, U-3264, U-3998	20 Feb 2030	4 listing rows
US 9416136 listing row	use U-2505	20 Aug 2029	listed 19 May 2017
US 9416136 listing row	use U-3264	20 Aug 2029	listed 19 May 2017
US 9416136 listing row	use U-3998	20 Aug 2029	listed 19 May 2017
US 9416136 listing row	pediatric extension	20 Feb 2030
US 8324225	drug substance, drug product	17 Dec 2028	2 listing rows
US 8324225 listing row	drug substance, drug product	17 Jun 2028	listed 19 May 2017
US 8324225 listing row	pediatric extension	17 Dec 2028

Exclusivities · 3 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-951	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	Approved	Listed expiry
209935 · 001 · RLD	tablet, oral	2.5MG;EQ 200MG BASE	4 May 2017	14 Oct 2036