CORLANOR Drug Patent Profile

Which patents cover Corlanor, and what generic alternatives are available?

Corlanor is a drug marketed by Amgen Inc and is included in two NDAs. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-seven patent family members in forty-two countries.

The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Corlanor

A generic version of CORLANOR was approved as ivabradine hydrochloride by INGENUS PHARMS LLC on December 30^th, 2021.

Summary for CORLANOR

International Patents:	97
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	6
Patent Applications:	215
Drug Prices:	Drug price information for CORLANOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CORLANOR
What excipients (inactive ingredients) are in CORLANOR?	CORLANOR excipients list
DailyMed Link:	CORLANOR at DailyMed

See drug prices for CORLANOR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CORLANOR

NDA:

209964

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CORLANOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amgen	Phase 3
Phillip Levy	Phase 4
iRhythm Technologies, Inc.	Phase 4

See all CORLANOR clinical trials

Pharmacology for CORLANOR

Drug Class	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
Mechanism of Action	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists

Paragraph IV (Patent) Challenges for CORLANOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CORLANOR	Tablets	ivabradine hydrochloride	5 mg and 7.5 mg	206143	6	2019-10-15

US Patents and Regulatory Information for CORLANOR

CORLANOR is protected by eight US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No					Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No					Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes					Y
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes			Y	Y
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for CORLANOR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Les Laboratoires Servier	Procoralan	ivabradine	EMEA/H/C/000597 Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.	Authorised	no	no	no	2005-10-25
Les Laboratoires Servier	Corlentor	ivabradine	EMEA/H/C/000598 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.	Authorised	no	no	no	2005-10-25
Zentiva, k.s.	Ivabradine Zentiva	ivabradine	EMEA/H/C/004117 Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersorin combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.	Authorised	yes	no	no	2016-11-11
"Anpharm" Przedsiębiorstwo Farmaceutyczne S.A.	Ivabradine Anpharm	ivabradine	EMEA/H/C/004187 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.	Authorised	no	no	no	2015-09-08
Accord Healthcare S.L.U.	Ivabradine Accord	ivabradine	EMEA/H/C/004241 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.Ivabradine is indicated :- in adults unable to tolerate or with a contra-indication to the use of beta-blockers- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1)	Authorised	yes	no	no	2017-05-22

International Patents for CORLANOR

See the table below for patents covering CORLANOR around the world.

Country	Patent Number	Title	Estimated Expiration
Cuba	23614	FORMA CRISTALINA BETA DEL CLORHIDRATO DE LA IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y LAS COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN
Jordan	2548	الشكل البلوري بيتا لهيدروكلوريد الايفابراداين وعملية تحضيره والمكونات الصيدلانية المحتوية علية (Beta Crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it)
Peru	20061009	FORMA CRISTALINA BETA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACION, Y COMPOSICIONES FARMACEUTICAS QUE LA CONTIENEN
Ukraine	80904	CRYSTALLINE FORM BETA OF THE CHLORHYDRATE OF IVABRADINE, PROCESS FOR ITS PREPARATION AND PHARAMCETUICAL COMPOSITION CONTAINING IT
Uruguay	29406	FORMA CRISTALINA GAMMA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN.

Market Dynamics and Financial Trajectory for CORLANOR

Introduction to CORLANOR

CORLANOR, generically known as ivabradine, is a significant advancement in the treatment of systolic heart failure. Approved by the U.S. Food and Drug Administration (FDA) in 2015, it marked the first new heart drug approved in almost a decade[1].

Mechanism of Action

CORLANOR is an oral medication taken twice a day, designed to target the heart rate by slowing down the pacemaker cells in the heart. This action helps reduce the heart rate by up to 15 points, which is crucial for patients with heart failure who often experience adverse outcomes when their heart rates are elevated[1].

Clinical Trials and Efficacy

The FDA approval of CORLANOR was based on a large clinical trial involving 6,505 patients with long-lasting heart failure, conducted across 667 sites in 38 countries. The trial demonstrated that CORLANOR can decrease the risk of hospitalization and cardiovascular death by 18%, primarily through a reduction in the risk of hospitalization due to worsening heart failure[4].

Market Need and Impact

Heart failure affects approximately 5 million people in the U.S., making it a leading cause of disability and death. The approval of CORLANOR brought new hope for these patients, offering a treatment option that can be added to existing regimens without lowering blood pressure, a common side effect of other heart failure medications[1].

Pricing and Affordability

One of the significant challenges associated with CORLANOR is its high cost. In the United States, a 60-pill supply can cost around $500, or approximately $8.33 per pill. This price can vary but remains substantially higher than in countries with government price controls, such as Canada. For instance, a generic version of ivabradine can be purchased at a much lower cost from international pharmacies[3].

Financial Performance of Amgen

Amgen, the manufacturer of CORLANOR, has seen significant financial growth in recent years. While the specific revenue from CORLANOR is not detailed separately, Amgen's overall product sales have been robust. For example, in the first quarter of 2024, Amgen reported total revenues of $7.4 billion, a 22% increase from the first quarter of 2023. This growth is driven by increased volume and pricing of their products, including potentially CORLANOR[5].

Market Competition

The heart failure treatment market is competitive, with other drugs also in the pipeline. For instance, Novartis's LCZ696, another heart failure drug, was noted to be in the approval process around the same time as CORLANOR and has also shown promising results in reducing the risk of re-hospitalization[1].

Side Effects and Safety Profile

While CORLANOR has shown significant benefits, it also comes with potential side effects. These include bradycardia (slowing of the heart rate), a small risk of atrial fibrillation (irregular heart rate), vision changes, and increased blood pressure. These side effects, although relatively low in incidence, are important considerations for prescribing physicians[1].

Patient Access and Affordability Strategies

Given the high cost of CORLANOR, patients often seek alternative ways to access the medication at a lower price. This includes purchasing from international pharmacies where government price controls keep drug prices lower. For example, a generic version of ivabradine can be obtained for about $0.65 per pill from certain online pharmacies, significantly cheaper than the U.S. market price[3].

Regulatory Environment

The lack of government price controls in the United States is a significant factor in the high cost of CORLANOR and other prescription drugs. Unlike many other countries, the U.S. does not set maximum prices for pharmaceuticals, leaving consumers vulnerable to high prices set by pharmaceutical companies[3].

Future Outlook

The approval of CORLANOR has opened up new avenues for the treatment of heart failure, and its integration into clinical practice is expected to continue. As more patients benefit from this medication, the demand is likely to remain strong, contributing to Amgen's financial performance. However, the ongoing issue of affordability will need to be addressed through various strategies, including potential government interventions or alternative sourcing options.

Key Takeaways

• Approval and Mechanism: CORLANOR is the first new heart drug approved in almost a decade, targeting heart rate to reduce hospitalization and cardiovascular death in patients with systolic heart failure.
• Clinical Trials: The drug was approved based on a large international clinical trial showing significant efficacy.
• Pricing: CORLANOR is expensive in the U.S., but cheaper alternatives are available from international pharmacies.
• Financial Performance: Amgen's overall financial growth indicates strong product sales, though specific CORLANOR revenue is not detailed.
• Market Competition: Other heart failure drugs are in the pipeline, including Novartis's LCZ696.
• Side Effects: The drug has potential side effects such as bradycardia and atrial fibrillation.
• Regulatory Environment: Lack of government price controls in the U.S. contributes to high drug prices.

FAQs

What is CORLANOR used for?

CORLANOR is used to reduce the risk of hospitalization for patients with systolic heart failure by targeting and slowing down the heart rate.

How does CORLANOR differ from other heart failure medications?

Unlike other heart failure medications, CORLANOR specifically targets the heart rate without lowering blood pressure, making it a valuable addition to existing treatment regimens.

Why is CORLANOR so expensive in the U.S.?

The high cost of CORLANOR in the U.S. is due to the lack of government price controls, allowing pharmaceutical companies to set higher prices compared to countries with such controls.

What are the potential side effects of CORLANOR?

Potential side effects include bradycardia (slowing of the heart rate), atrial fibrillation (irregular heart rate), vision changes, and increased blood pressure.

How can patients access CORLANOR at a lower cost?

Patients can access cheaper versions of CORLANOR by purchasing from international pharmacies, particularly those in countries with government price controls.

Sources

1. CBS News: FDA approves first heart drug in almost a decade
2. Corcept Therapeutics: Fourth Quarter and Full-Year 2023 Financial Results
3. NorthWestPharmacy: How to Get Corlanor at a Lower Price
4. FDA: Drug Trials Snapshot: CORLANOR
5. PR Newswire: AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS