Viewing data from:

CORLANOR

NDA

IVABRADINE HYDROCHLORIDE | N206143 | AMGEN INC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Expired (3)Expiring < 1yr (1)TodayPED (+6 mo)

2027

Today

Aug. 22, 2026

Aug. 22, 2026

Jun. 12, 2027

Aug. 22, 2026

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

8 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Amgen Inc. et al v. Alembic Pharmaceuticals Limited et al 1:2021cv00061	D. Del.	2021-01-20	Terminated 2021-06-08	—
Amgen Inc. et al v. MSN Pharmaceuticals, Inc. et al 1:2020cv00137	D. Del.	2020-01-29	Terminated 2021-10-13	—
Amgen Inc. et al v. Annora Pharma Private Limited et al 1:2020cv00122	D. Del.	2020-01-24	Terminated 2022-02-09	—
Amgen Inc. et al v. Centaur Pharmaceuticals Private Ltd. 1:2020cv00123	D. Del.	2020-01-24	Terminated 2021-02-16	—
Amgen Inc. et al v. Bionpharma, Inc. 1:2020cv00105	D. Del.	2020-01-23	Terminated 2021-12-06	—
AMGEN INC. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 3:2020cv00678 4 patentsANDA 213442ivabradine	D.N.J.	2020-01-21	Terminated 2020-05-08	—
Amgen Inc. et al v. Zydus Pharmaceuticals (USA) Inc. et al 1:2020cv00075	D. Del.	2020-01-17	Terminated 2021-12-20	—
Amgen Inc. et al v. Torrent Pharma Inc. et al 1:2020cv00065	D. Del.	2020-01-16	Terminated 2022-02-16	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

64 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ivabradine for Heart Rate Control In Septic Shock NCT04031573	Phase 3	Active	Assistance Publique - Hôpitaux de Paris	429	2021-02-26 → 2026-04-22
Crossover Study of Propranolol vs Ivabradine in POTS NCT04186286	Phase 2	Recruiting	University of Calgary	20	2021-02-01 → 2026-12-31
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome NCT03182725	Phase 3	Completed	University of California, San Diego	37	2018-02-06 → 2020-05-08
HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease NCT01365286	Phase 4	Completed	Medical University of Lodz	40	2009-05 → 2011-01
Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine NCT01373619	Phase 4	Completed	University of Campania Luigi Vanvitelli	150	2010-01 → 2012-01
Heart Rate Reduction in Heart Failure NCT01178528	Phase 3	Completed	IRCCS San Raffaele	121	2009-09 → 2010-10
Ivabradine for Rate Control in Permanent Atrial Fibrillation NCT03987204	Phase 1	Completed	Yale University	4	2019-06-15 → 2019-09-17
Efficacy Study of Digoxin & Ivabradine to Treat Heart Failure NCT01699776	Phase 4	Completed	Cocco, Giuseppe, M.D.	22	2008-04 → 2012-02
Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers NCT03485482	Phase 3	Completed	Ain Shams University	18	2018-03-01 → 2018-03-23
The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction NCT00143507	Phase 3	Completed	Institut de Recherches Internationales Servier	10,917	2004-12 → 2008-02

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

$9.99

per ea

Lowest NADAC/Unit

$9.98

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
55513081060CORLANOR 7.5 MG TABLET	$9.99	EA	Brand	$0.7371	2026-06-17
55513080060CORLANOR 5 MG TABLET	$9.98	EA	Brand	$0.7713	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$444.22

Highest Price

$528.51

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55513-0800-60CORLANOR 5MG TAB	$528.51	FSS	Amgen USA, Inc.	07/31/2026
55513-0800-60CORLANOR 5MG TAB	$445.86	Big4	Amgen USA, Inc.	07/31/2026
55513-0810-60CORLANOR 7.5MG TAB	$528.51	FSS	Amgen USA, Inc.	07/31/2026
55513-0810-60CORLANOR 7.5MG TAB	$444.22	Big4	Amgen USA, Inc.	07/31/2026

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

Medicare Part D Spending

CMS annual spending data for Corlanor (2024)

Total Spending

$40.0M

Total Claims

50,208

Beneficiaries

12,631

Avg Cost/Unit

$9.67

Spending Trend

$21.5M(2019)→$26.5M(2020)→$31.3M(2021)→$38.4M(2022)→$47.3M(2023)→$40.0M(2024)

YoY Change:-2.8%

5yr CAGR:+5.4%

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

API Supply Chain10 active DMFs

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

ORIL INDUSTRIEIVABRADINE HYDROCHLORIDE

DMF 279792014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDIVABRADINE HYDROCHLORIDE

DMF 286582014

ALEMBIC PHARMACEUTICALS LTDIVABRADINE HYDROCHLORIDE

DMF 320742017

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 326162019

BIONPHARMA INCIVABRADINE HYDROCHLORIDE

DMF 330772018

ZYDUS LIFESCIENCES LTDIVABRADINE HYDROCHLORIDE

DMF 331072018

URQUIMA SAIVABRADINE HYDROCHLORIDE (FORM IV)

DMF 332132018

MAITHRI LABORATORIES PRIVATE LTDIVABRADINE HYDROCHLORIDE

DMF 332462018

HETERO DRUGS LTDIVABRADINE HYDROCHLORIDE

DMF 333682018

FUXIN LONG RUI PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 333772018

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2021	SUPPL -8	View Letter (PDF)
May 15, 2019	SUPPL -7	View Letter (PDF)
Jan 19, 2017	SUPPL -2	View Letter (PDF)
Apr 16, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 15, 2015

Patents (4) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7361649	Feb 22, 2026PED: Aug 22, 2026	PED	Yes	Yes	—
7361650	Feb 22, 2026PED: Aug 22, 2026	PED	Yes	Yes	—
7867996	Dec 12, 2026PED: Jun 12, 2027	PED	Yes	Yes	—
7879842	Feb 22, 2026PED: Aug 22, 2026	PED	Yes	Yes	—

#002 — EQ 7.5MG BASE

RLD

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 15, 2015