Viewing data from:

KISQALI

NDA

RIBOCICLIB SUCCINATE | N209092 | NOVARTIS PHARMACEUTICALS CORP

1 strength12 unique patents3 unique exclusivities

Patent Timeline

12 unique patents, 1 exclusivity by expiration date

Active (12)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Dec. 17, 2028

Sep. 13, 2031

Nov. 25, 2030

Jun. 9, 2030

May. 9, 2032

Feb. 20, 2030

May. 9, 2032

Oct. 14, 2036

Oct. 14, 2036

Oct. 14, 2036

Feb. 7, 2035

Feb. 7, 2035

I-950

Mar. 17, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

7 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Alembic Pharmaceuticals Ltd. et al 1:2025cv00350 5 patentsANDA 215676, 215677ribociclib	D. Del.	2025-03-20	Terminated 2025-03-28	—
Novartis Pharmaceuticals Corporation et al v. Natco Pharma Limited et al 1:2024cv01367	D. Del.	2024-12-13	Terminated 2025-05-01	—
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 1:2024cv01193 2 patentsANDA 215976ribociclib	D. Del.	2024-10-24	Terminated 2025-02-04	—
Novartis Pharmaceuticals Corporation et al v. Natco Pharma Limited et al 1:2024cv01033 2 patentsANDA 219528ribociclib	D. Del.	2024-09-13	Terminated 2025-05-01	—
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 1:2023cv00550 2 patentsANDA 215975, 215976ribociclib	D. Del.	2023-05-19	Terminated 2025-02-04	—
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 1:2021cv01102 5 patentsANDA 215976ribociclib	D. Del.	2021-07-29	Terminated 2025-02-04	—
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 1:2021cv00870 8 patentsANDA 214746, 214771ribociclib	D. Del.	2021-06-17	Terminated 2025-02-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

52 trials from ClinicalTrials.gov — 5 recruiting, 11 active, 26 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL NCT03740334	Phase 1	Active	Dana-Farber Cancer Institute	45	2019-01-30 → 2026-10-01
Ribociclib and Bicalutamide in AR+ TNBC NCT03090165	Phase 1/2	Active	Kari Wisinski	37	2018-05-07 → 2026-10
Ribociclib and Letrozole Treatment in Ovarian Cancer NCT03673124	Phase 2	Active	Gynecologic Oncology Group	51	2019-05-20 → 2026-12-31
A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma NCT03008408	Phase 2	Active	M.D. Anderson Cancer Center	90	2017-08-18 → 2028-08-31
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer NCT02608216	Phase 1	Active	University of Pennsylvania	20	2015-11 → 2026-11
Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.NCT03283384	Phase 2	Active	Borstkanker Onderzoek Groep	100	2019-06-15 → 2027-08
Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.NCT03616587	Phase 1	Active	AstraZeneca	396	2018-10-11 → 2027-06-24
Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)NCT03114527	Phase 2	Active	Fox Chase Cancer Center	48	2017-08-08 → 2026-12
FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer NCT03944434	Phase 2	Active	Fondazione Sandro Pitigliani	116	2018-12-27 → 2025-11-27
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer NCT03425838	Phase 3	Active	Borstkanker Onderzoek Groep	1,050	2017-11-09 → 2028-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$346.95

per ea

Lowest NADAC/Unit

$289.72

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078086742KISQALI 400 MG DAILY DOSE	$346.95	EA	Brand	—	2026-06-17
00078087463KISQALI 600 MG DAILY DOSE	$289.72	EA	Brand	—	2026-04-22

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$5126.82

Highest Price

$15007.70

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0860-01KISQALI FCT 200MG TAB, 21(200MG) DAILY PKT	$6003.05	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0860-01KISQALI FCT 200MG TAB, 21(200MG) DAILY PKT	$5126.82	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0867-42KISQALI FCT 200MG TAB, 42 (400MG) DAILY PKT	$12006.14	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0867-42KISQALI FCT 200MG TAB, 42 (400MG) DAILY PKT	$10239.43	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0874-63KISQALI FCT 200MG TAB, 63(600MG) DAILY PKT	$15007.70	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0874-63KISQALI FCT 200MG TAB, 63(600MG) DAILY PKT	$12805.01	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Kisqali (2024)

Total Spending

$775.5M

Total Claims

52,578

Beneficiaries

8,782

Avg Cost/Unit

$296.84

Spending Trend

$92.0M(2019)→$128.7M(2020)→$119.3M(2021)→$166.3M(2022)→$370.8M(2023)→$775.5M(2024)

YoY Change:+0.8%

5yr CAGR:+6.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDRIBOCICLIB SUCCINATE

DMF 350982020

TAPI NL BVRIBOCICLIB SUCCINATE

DMF 352882020

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDRIBOCICLIB SUCCINATE

DMF 361742021

INTAS PHARMACEUTICALS LTDRIBOCICLIB SUCCINATE

DMF 363352021

MSN LABORATORIES PRIVATE LTDRIBOCICLIB SUCCINATE [ROUTE CODE RBA]

DMF 411792025

VALARY LAB PRIVATE LIMITEDRIBOCICLIB SUCCINATE

DMF 414242025

ALEMBIC PHARMACEUTICALS LTDRIBOCICLIB SUCCINATE

DMF 415182025

CIPLA LTDRIBOCICLIB SUCCINATE

DMF 436262026

FRESENIUS KABI ONCOLOGY LTDInactiveRIBOCICLIB SUCCINATE

DMF 350272020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jul 6, 2026	SUPPL -27	View Letter (PDF)
Dec 1, 2025	SUPPL -25	View Letter (PDF)
Jul 29, 2025	SUPPL -24	View Letter (PDF)
Feb 12, 2025	SUPPL -23	View Letter (PDF)
Oct 15, 2024	SUPPL -20	View Letter (PDF)
Sep 19, 2024	SUPPL -18	View Letter (PDF)
Jul 23, 2024	SUPPL -19	View Letter (PDF)
Aug 28, 2023	SUPPL -16	View Letter (PDF)
Oct 4, 2022	SUPPL -13	View Letter (PDF)
Dec 16, 2021	SUPPL -8	View Letter (PDF)
Sep 17, 2021	SUPPL -9	View Letter (PDF)
Jul 7, 2020	SUPPL -5	View Letter (PDF)
Jan 22, 2020	SUPPL -3	View Letter (PDF)
Sep 11, 2019	SUPPL -4	View Letter (PDF)
Jul 24, 2018	SUPPL -1	View Letter (PDF)
Mar 13, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 200MG BASE

RLD

12 patents3 exclusivities▴

TABLET;ORAL | Approved: Mar 13, 2017

Patents (12) · 24 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8324225	Jun 17, 2028PED: Dec 17, 2028	PED	Yes	Yes	—	—
8415355	Mar 13, 2031PED: Sep 13, 2031	PED	Yes	Yes	—	—
8685980	May 25, 2030PED: Nov 25, 2030	PED	Yes	Yes	—	—
8962630	Dec 9, 2029PED: Jun 9, 2030	PED	—	—		—
9193732	Nov 9, 2031PED: May 9, 2032	PED	Yes	Yes	—	—
9416136	Aug 20, 2029PED: Feb 20, 2030	PED	—	—		—
9868739	Nov 9, 2031PED: May 9, 2032	PED	—	—		—
10799506	Apr 14, 2036PED: Oct 14, 2036	PED	—	Yes	—	—
12064434	Apr 14, 2036PED: Oct 14, 2036	PED	—	Yes	—	—
12419894	Apr 14, 2036PED: Oct 14, 2036	PED	—	Yes	—	—
12544379	Aug 7, 2034PED: Feb 7, 2035	PED	—	—		—
12544380	Aug 7, 2034PED: Feb 7, 2035	PED	—	—		—

Exclusivities (3)

Code	Date	Status
I-950	Sep 17, 2027	Active
PED	Mar 17, 2028	Active
I-950*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Mar 17, 2028	Active