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LEQVIO

NDA

INCLISIRAN SODIUM | N214012 | NOVARTIS PHARMACEUTICALS CORP

1 strength10 unique patents3 unique exclusivities

Patent Timeline

10 unique patents, 3 exclusivities by expiration date

Expiring < 1yr (1)Active (9)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Dec. 12, 2029

Dec. 29, 2027

May. 10, 2027

Dec. 4, 2028

Dec. 4, 2028

Aug. 18, 2034

Aug. 24, 2028

Dec. 4, 2028

Aug. 25, 2036

Aug. 18, 2034

NCE

Dec. 22, 2026

I-985

Feb. 12, 2029

NPP

Feb. 12, 2029

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Cipla USA Inc. et al 1:2026cv00272 3 patentsANDA 220297inclisiran	D. Del.	2026-03-13	Active	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Novartis Pharmaceuticals Corporation FDA-2025-P-6315 Novartis Pharmaceuticals Corporation filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any abbreviated new drug application (ANDA) under section 505(j) or new drug application (NDA) under section 505(b)(2) referencing	505(q)	2025-11-19	Denied	Novartis Pharmaceuticals Corporation

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

4 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events NCT05360446	Phase 3	Active	Novartis Pharmaceuticals	608	2022-07-08 → 2026-10-26
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes NCT07102628	Phase 3	Recruiting	Novartis Pharmaceuticals	300	2025-10-03 → 2027-02-11
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention NCT06909565	Phase 4	Recruiting	Duke University	6,000	2025-07-23 → 2029-12
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia NCT06386419	Phase 4	Completed	Novartis Pharmaceuticals	65	2024-11-12 → 2026-01-13

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

Medicare Part D Spending

CMS annual spending data for Leqvio (2023)

Total Spending

$10.6M

Total Claims

2,995

Beneficiaries

1,840

Avg Cost/Unit

$2348.80

Spending Trend

$3.8M(2022)→$10.6M(2023)

YoY Change:+2.8%

5yr CAGR:+2.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Leqvio (2023)

Total Spending

$143.2M

Total Claims

43,125

Beneficiaries

24,690

ASP Price

—

HCPCS: J1306 — Injection, inclisiran, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HANGZHOU APEXTIDE BIOMEDICAL TECHNOLOGY CO LTDINCLISIRAN

DMF 417762025

YANGZHOU AURISCO PHARMACEUTICAL CO LTDINCLISIRAN SODIUM

DMF 420952025

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2026	SUPPL -18	View Letter (PDF)
Feb 13, 2026	SUPPL -17	View Letter (PDF)
Aug 1, 2025	SUPPL -16	View Letter (PDF)
Jun 7, 2024	SUPPL -11	View Letter (PDF)
Jul 10, 2023	SUPPL -9	View Letter (PDF)
Feb 21, 2023	SUPPL -6	View Letter (PDF)
Jun 7, 2022	SUPPL -2	View Letter (PDF)
Dec 23, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

RLD

10 patents3 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 22, 2021

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8106022	Dec 12, 2029	—	Yes	Yes		—
8222222	Dec 29, 2027	—	—	—		—
8809292	May 10, 2027	—	Yes	Yes	U-4413	—
8828956	Dec 4, 2028	—	Yes	Yes	U-4413	—
9370582	Dec 4, 2028	—	Yes	Yes	U-4413	—
10125369	Aug 18, 2034	—	Yes	Yes	U-4413	—
10131907	Aug 24, 2028	—	Yes	Yes	U-4413	—
10806791	Dec 4, 2028	—	Yes	—	—	—
10851377	Aug 25, 2036	—	—	—	U-4413	—
12460206	Aug 18, 2034	—	Yes	Yes	—	—

Exclusivities (3)

Code	Date	Status
I-985	Feb 12, 2029	Active
NCE	Dec 22, 2026	< 1 year
NPP	Feb 12, 2029	Active